Behavior therapy and sibutramine for the treatment of adolescent obesity: a randomized controlled trial. Addition of orlistat to conventional treatment in adolescents with severe obesity. Treatment of obese adolescents with sibutramine: a randomized, double-blind, controlled study. Effect of orlistat on weight and body composition in obese adolescents: a randomized controlled trial. Effects of sibutramine treatment in obese adolescents: a randomized trial. The effect of sibutramine on energy expenditure and body composition in obese adolescents. Weight loss, weight maintenance, and improved cardiovascular risk factors after 2 years treatment with orlistat for obesity. European Orlistat Obesity Study Group. Orlistat in the long-term treatment of obesity in primary care settings. A double-blind, placebo-controlled trial of sibutramine for olanzapine-associated weight gain. A randomized study of orlistat in combination with a weight management programme in obese patients with Type 2 diabetes treated with metformin. Clinical efficacy of group-based treatment for childhood obesity compared with routinely given individual counseling. Clinical evaluation of sibutramine in obese type 2 diabetic patients refractory to dietary management. One-year outcome of a combination of weight loss therapies for subjects with type 2 diabetes: a randomized trial. Cognitive behavioral therapy guided self-help and orlistat for the treatment of binge eating disorder: a randomized, double-blind, placebo-controlled trial. Clinical efficacy of orlistat therapy in overweight and obese patients with insulin-treated type 2 diabetes: A 1-year randomized controlled trial. Weight reduction by sibutramine in obese subjects in primary care medicine: the SAT Study. 'Adventure therapy' combined with cognitive-behavioral treatment for overweight adolescents. Randomized, controlled trial of a best-practice individualized behavioral program for treatment of childhood overweight: Scottish Childhood Overweight Treatment Trial (SCOTT). Conceptualisation and evaluation of a cognitive-behavioural training programme for children and adolescents with obesity. XENical in the prevention of diabetes in obese subjects (XENDOS) study: a randomized study of orlistat as an adjunct to lifestyle changes for the prevention of type 2 diabetes in obese patients. Weight control and risk factor reduction in obese subjects treated for 2 years with orlistat: a randomized controlled trial. Role of orlistat in the treatment of obese patients with type 2 diabetes. A 1-year randomized double-blind study. Randomized, double-blind, placebo-controlled trial of orlistat for weight loss in adolescents. Behavioral weight control for overweight adolescents initiated in primary care. Randomized controlled comparison of two cognitive behavioral therapies for obese children: mother versus mother-child cognitive behavioral therapy. Cost-effectiveness of group and mixed family-based treatment for childhood obesity. [Evaluation of an outpatient treatment program for obese children and adolescents]. A cognitive/behavioral group intervention for weight loss in patients treated with atypical antipsychotics. Use of sibutramine in obese mexican adolescents: a 6-month, randomized, double-blind, placebo-controlled, parallel-group trial. Childhood obesity treatment: targeting parents exclusively v. parents and children. Role of sibutramine in the treatment of obese Type 2 diabetic patients receiving sulphonylurea therapy. Use of sibutramine in overweight adult hispanic patients with type 2 diabetes mellitus: a 12-month, randomized, double-blind, placebo-controlled clinical trial. Role of behaviour modification in the treatment of childhood obesity with the parents as the exclusive agents of change. Randomised placebo-controlled trial of orlistat for weight loss and prevention of weight regain in obese patients. European Multicentre Orlistat Study Group. Inpatient treatment for children with obesity: weight loss, psychological well-being, and eating behavior. A 4-year, cluster-randomized, controlled childhood obesity prevention study: STOPP. Transtheoretical model-based multiple behavior intervention for weight management: effectiveness on a population basis. [Individual outpatient care versus group education programs. Which leads to greater change in dietary and physical activity habits for obese children?]. Randomized placebo-controlled trial of long-term treatment with sibutramine in mild to moderate obesity. Sibutramine is effective for weight loss and diabetic control in obesity with type 2 diabetes: a randomised, double-blind, placebo-controlled study. The effectiveness of cognitive self-management as an adjunct to a behavioural intervention for childhood obesity: a research note. Effectiveness of a multi-disciplinary family-based programme for treating childhood obesity (the Family Project). A two year family based behaviour treatment for obese children. Effects of moderate weight loss and orlistat on insulin resistance, regional adiposity, and fatty acids in type 2 diabetes. Exercise therapy as a treatment for psychopathologic conditions in obese and morbidly obese adolescents: a randomized, controlled trial. Health-related quality of life in a randomised placebo-controlled trial of sibutramine in obese patients with type II diabetes. The effect of orlistat on body weight and coronary heart disease risk profile in obese patients: the Swedish Multimorbidity Study. One-year treatment of obesity: a randomized, double-blind, placebo-controlled, multicentre study of orlistat, a gastrointestinal lipase inhibitor. Effects of behavioral therapy on weight loss in overweight and obese patients with schizophrenia or schizoaffective disorder. Efficacy of an internet-based behavioral weight loss program for overweight adolescent African-American girls. An evaluation of enhanced self-regulation training in the treatment of childhood obesity. Nutritional intervention to prevent weight gain in patients commenced on olanzapine: a randomized controlled trial. Weight loss with sibutramine improves glycaemic control and other metabolic parameters in obese patients with type 2 diabetes mellitus. Outcomes of a group-randomized trial to prevent excess weight gain, reduce screen behaviours and promote physical activity in 10-year-old children: switch-play. Who benefits from intervention in, as opposed to screening of, overweight and obese children? Orlistat improves blood pressure control in obese subjects with treated but inadequately controlled hypertension. Short- and long-term beneficial effects of a combined dietary-behavioral-physical activity intervention for the treatment of childhood obesity.
Adolescent obesity is becoming a national public health problem. Weight-loss medications including sibutramine facilitate weight control in adults and could be used with obese adolescents in combination with behavior therapy (BT).
                To examine whether increased weight loss in obese adolescents is induced when sibutramine is added to a family-based, behavioral weight control program.
                Randomized, double-blind, placebo-controlled trial consisting of 82 adolescents aged 13 to 17 years with a body mass index (BMI) of 32 to 44 conducted from March 1999 to August 2002 at a university-based clinic for 6 months, followed by open-label treatment during months 7 to 12.
                For the first 6 months, participants received either BT and sibutramine or BT and placebo. From months 7 to 12, all participants received sibutramine in open-label treatment.
                Percentage change in BMI; systolic and diastolic blood pressure and pulse; and hunger.
                In intention-to-treat analysis at month 6, participants in the BT and sibutramine group lost a mean (SD) of 7.8 kg (6.3 kg) and had an 8.5% (6.8%) reduction in BMI, which was significantly more than weight loss of 3.2 kg (6.1 kg) and reduction in BMI of 4.0% (5.4%) in the BT and placebo group. Significantly greater reductions in hunger (P =.002) also were reported by participants who received BT and sibutramine. From months 7 to 12, adolescents initially treated with sibutramine gained 0.8 kg (10.5 kg) with continued use of the medication, whereas those who switched from placebo to sibutramine lost an additional 1.3 kg (5.4 kg). Medication dose was reduced (n = 23) or discontinued (n = 10) to manage increases in blood pressure, pulse rate, or other symptoms.
                The addition of sibutramine to a comprehensive behavioral program induced significantly more weight loss than did BT and placebo. Until more extensive safety and efficacy data are available, medications for weight loss should be used only on an experimental basis in adolescents and children. To investigate the efficacy and tolerability of orlistat in obese adolescents, a prospective, open-label, randomised, controlled pilot trial was performed. A total of 22 adolescents with exogeneous obesity were started on orlistat (120 mg tid) and a daily multivitamin preparation in addition to conventional treatment which included nutritional and lifestyle modification programmes. The control group consisted of 20 obese adolescents who had similar duration of follow-up under conventional treatment alone. Of the 22 patients, 7 dropped out within the 1st month of the trial due to side-effects attributable to orlistat. The remaining 15 patients on orlistat were followed for 5-15 months (average duration of treatment 11.7 +/- 3.7 months). The control group was similar in age, sex, and duration of follow-up (10.2 +/- 3.7 months, range 6-17 months) to the orlistat group. Compared to initial body weight, patients in the orlistat group lost -6.27 +/- 5.4 kg, whereas those in the control group gained 4.16 +/- 6.45 kg (P < 0.001) during the study period. Patients in the orlistat group lost -7.65% +/- 6.5% of their initial body weight, whereas, those of the control group gained 5.7% +/- 8.3% (P < 0.001). The body mass index decreased in the orlistat group by -4.09 +/- 2.9 kg/m2 while it increased by + 0.11 +/- 2.49 kg/m2 in the control group (P < 0.001). Mild gastrointestinal complaints (frequent stools) were experienced by all patients in the orlistat group. Conclusion: Orlistat could be a useful adjunct in the treatment of severe obesity in adolescents; however, gastrointestinal side-effects limit its usefulness in almost one in three adolescents. Adolescent obesity is becoming a health problem in both developed and developing countries. Antiobesity drug therapy is not currently indicated for the treatment of adolescent obesity and remains investigational at this time. The aim of this study was to determine the efficacy and safety of sibutramine in obese adolescents. A randomized, double-blind, placebo-controlled trial, enrolling 60 adolescents, aged 14-17 yr, for 6 months was conducted. In the first month, all patients received placebo and a hypocaloric diet plus exercise orientation. For the next 6 months, participants received either sibutramine or placebo. Patients assigned to sibutramine group lost an average of 10.3 +/- 6.6 kg, and patients in placebo group lost 2.4 +/- 2.5 kg (P < 0.001). The mean body mass index reduction was significantly greater in the sibutramine group (3.6 +/- 2.5 kg/m(2)) than in the placebo group (0.9 +/- 0.9 kg/m(2); P < 0.001). No participant withdrew because of adverse events, and no difference in blood pressure or heart rate was noted between groups. There were no changes in echocardiographic parameters. In conclusion, sibutramine plus diet and exercise induced significantly more weight loss in obese adolescents. The prevalence of overweight and obesity in children and adolescents is increasing rapidly. In this population, behavioral therapy alone has had limited success in providing meaningful, sustained weight reduction, and pharmacological treatment has not been extensively studied.
                To determine the efficacy and safety of orlistat in weight management of adolescents.
                Multicenter, 54-week (August 2000-October 2002), randomized, double-blind study of 539 obese adolescents (aged 12-16 years; body mass index [BMI] >or=2 units above the 95th percentile) at 32 centers in the United States and Canada.
                A 120-mg dose of orlistat (n = 357) or placebo (n = 182) 3 times daily for 1 year, plus a mildly hypocaloric diet (30% fat calories), exercise, and behavioral therapy.
                Change in BMI; secondary measures included changes in waist and hip circumference, weight loss, lipid measurements, and glucose and insulin responses to oral glucose challenge.
                There was a decrease in BMI in both treatment groups up to week 12, thereafter stabilizing with orlistat but increasing beyond baseline with placebo. At the end of the study, BMI had decreased by 0.55 with orlistat but increased by 0.31 with placebo (P = .001). Compared with 15.7% of the placebo group, 26.5% of participants taking orlistat had a 5% or higher decrease in BMI (P = .005); 4.5% and 13.3%, respectively, had a 10% or higher decrease in BMI (P = .002). At study end, weight had increased 0.53 kg with orlistat and 3.14 kg with placebo (P<.001). Dual-energy x-ray absorptiometry showed that this difference was explained by changes in fat mass. Waist circumference decreased in the orlistat group but increased in the placebo group (-1.33 cm vs +0.12 cm; P<.05). Generally mild to moderate gastrointestinal tract adverse events occurred in 9% to 50% of the orlistat group and in 1% to 13% of the placebo group.
                In combination with diet, exercise, and behavioral modification, orlistat statistically significantly improved weight management in obese adolescents compared with placebo. The use of orlistat for 1 year in this adolescent population did not raise major safety issues although gastrointestinal adverse events were more common in the orlistat group. Increased prevalence of adolescent obesity requires effective treatment options beyond behavior therapy.
                To see whether sibutramine reduced weight more than placebo in obese adolescents who were receiving a behavior therapy program.
                12-month, 3:1 randomized, double-blind trial conducted from July 2000 to February 2002.
                33 U.S. outpatient clinics.
                498 participants 12 to 16 years of age with a body mass index (BMI) that was at least 2 units more than the U.S. weighted mean of the 95th percentile based on age and sex, to the upper limit of 44 kg/m2. Interventions: Site-specific behavior therapy plus 10 mg of sibutramine or placebo. Blinded study medication dose was uptitrated to 15 mg or placebo at month 6 if initial BMI was not reduced by 10%.
                Body mass index, waist circumference, body weight, fasting lipid and glycemic variables, safety, and tolerability.
                Seventy-six percent of patients in the sibutramine group and 62% of patients in the placebo group completed the study. The estimated mean treatment group difference at month 12 (linear mixed-effects model) favored sibutramine for change from baseline in BMI (-2.9 kg/m2 [95% CI, -3.5 to -2.2 kg/m2]) and body weight (-8.4 kg [CI, -9.7 to -7.2 kg]) (P < 0.001 for both). The sibutramine group had greater improvements in triglyceride levels, high-density lipoprotein cholesterol levels, insulin levels, and insulin sensitivity (P < or = 0.001 for all). The rate of tachycardia was greater with sibutramine vs. placebo (12.5% vs. 6.2%; difference, 6.3 percentage points [CI, 1.0 to 11.7 percentage points]) but did not lead to increased withdrawal (2.4% vs. 1.5%; difference, 0.9 percentage point [CI, -1.7 to 3.5 percentage points]).
                The 1-year study duration precluded assessment of long-term weight maintenance and putative health benefits and harms, and 24% and 38% of the sibutramine and placebo groups, respectively, did not complete follow-up.
                Sibutramine added to a behavior therapy program reduced BMI and body weight more than placebo and improved the profile of several metabolic risk factors in obese adolescents. Childhood obesity is now considered to be an epidemic. Drug therapy in this age group remains a topic of research.
                The objective of this study was to examine the effect of treatment with sibutramine (10 mg) on body composition and energy expenditure in obese adolescents.
                The study was conducted as a randomized, double-blind, placebo-controlled trial.
                The study was set in an obesity research center.
                The patients were 24 obese adolescents (age 12-17 yr, 11 boys); four patients withdrew.
                Intervention was sibutramine (Meridia) or placebo in combination with an energy-restricted diet and exercise plan for 12 wk, followed by an identical, but medication-free, treatment period (follow-up).
                Change in body mass index (BMI) sd score (BMI-SDS) was the principal measure of efficacy. Body composition and total energy expenditure were measured by stable isotopes and further calculated according to the four-component model, using underwater weighing and dual x-ray absorptiometry. Basal metabolic rate (BMR) was measured by ventilated hood and adjusted for sex and body composition (BMRadj).
                After intervention, the decrease in BMI-SDS was comparable in both groups. During follow-up, BMI further decreased in the placebo group but stabilized in the sibutramine group. Changes in the percentage of fat mass were not different between both groups. BMRadj decreased in the placebo group and remained constant in the sibutramine group. During follow-up, BMRadj decreased in the sibutramine group and increased in the placebo group. Changes in total energy expenditure were not significantly different.
                The effect of sibutramine on BMI-SDS was not significant. Sibutramine may diminish the decrease in BMRadj associated with energy restriction in obese adolescents. To determine the effect of orlistat, a new lipase inhibitor, on long-term weight loss, to determine the extent to which orlistat treatment minimizes weight regain in a second year of treatment, and to assess the effects of orlistat on obesity-related risk factors.
                This was a 2-year, multicenter, randomized, double-blind, placebo-controlled study. Obese patients (body mass index 28 to 43 kg/m2) were randomized to placebo or orlistat (60 or 120 mg) three times a day, combined with a hypocaloric diet during the first year and a weight maintenance diet in the second year of treatment to prevent weight regain. Changes in body weight, lipid profile, glycemic control, blood pressure, quality of life, safety, and tolerability were measured.
                Orlistat-treated patients lost significantly more weight (p<0.001) than placebo-treated patients after Year 1 (6.6%, 8.6%, and 9.7% for the placebo, and orlistat 60 mg and 120 mg groups, respectively). During the second year, orlistat therapy produced less weight regain than placebo (p = 0.005 for orlistat 60 mg; p<0.001 for orlistat 120 mg). Several obesity-related risk factors improved significantly more with orlistat treatment than with placebo. Orlistat was generally well tolerated and only 6% of orlistat-treated patients withdrew because of adverse events. Orlistat leads to predictable gastrointestinal effects related to its mode of action, which were generally mild, transient, and self-limiting and usually occurred early during treatment.
                Orlistat administered for 2 years promotes weight loss and minimizes weight regain. Additionally, orlistat therapy improves lipid profile, blood pressure, and quality of life. To evaluate the long-term efficacy and tolerability within primary care settings of orlistat, a gastrointestinal lipase inhibitor, for the treatment of obesity.
                Randomized, double-blind, placebo-controlled, multicenter study.
                A group of 796 obese patients (body mass index, 30-44 kg/m2), treated with placebo 3 times a day (TID), 60 mg of orlistat TID, or 120 mg of orlistat TID, in conjunction with a reduced-energy diet for the first year and a weight-maintenance diet during the second year.
                Seventeen primary care centers in the United States.
                Changes in body weight and obesity-related disease risk factors.
                Patients treated with orlistat lost significantly more weight (7.08 +/- 0.54 and 7.94 +/- 0.57 kg for the 60-mg and 120-mg orlistat groups, respectively) than those treated with placebo (4.14 +/- 0.56 kg) in year 1 (P<.001) and sustained more of this weight loss during year 2 (P<.001). More patients treated with orlistat lost 5% or more of their initial weight in year 1 (48.8% and 50.5% of patients in the 60-mg and 120-mg groups, respectively) compared with placebo (30.7%; P<.001), and approximately 34% of patients in the orlistat groups sustained weight loss of 5% or greater over 2 years compared with 24% in the placebo group (P<.001). Orlistat produced greater improvements than placebo in serum lipid levels and blood pressure and was well tolerated, although treatment resulted in a higher incidence of gastrointestinal events.
                This long-term study indicates that orlistat is an effective adjunct to dietary intervention in the treatment of obesity in primary care settings. Weight gain is commonly observed with olanzapine treatment and can increase the risk for obesity, cardiovascular disease, hypertension, and diabetes mellitus. This study examined the effectiveness of sibutramine, an approved weight loss agent, in overweight and obese subjects taking olanzapine for schizophrenia or schizoaffective disorder.
                Each subject had a DSM-IV diagnosis of schizophrenia or schizoaffective disorder, had been taking a stable dose of olanzapine for at least 4 months, and had a body mass index of >/=30 kg/m(2) or >/=27 kg/m(2) plus at least one cardiovascular risk factor. In a 12-week double-blind, randomized, placebo-controlled study, 37 subjects received placebo or sibutramine (up to 15 mg/day). For the first 8 weeks all subjects participated in weekly group sessions focused on nutrition and behavioral modification.
                The sibutramine and placebo groups had no significant baseline differences on age, gender, education, ethnicity, diagnosis, weight, body mass index, and blood pressure. At week 12 the sibutramine group had significantly greater losses than the placebo group in weight (mean=8.3 lb, SD=2.4, versus mean=1.8 lb, SD=1.6), waist circumference, body mass index, and hemoglobin A(1c). There were no significant differences on most side effects, although the sibutramine group exhibited a mean increase in systolic blood pressure of 2.1 mm Hg (SD=8.5), and anticholinergic side effects and sleep disturbances were at least twice as common in the sibutramine group.
                Sibutramine was an effective and well-tolerated adjunct to behavior modification for weight loss in patients with schizophrenia and schizoaffective disorder being treated with olanzapine. To assess the effects of orlistat vs. placebo, in combination with a weight management programme, on weight loss and metabolic control in obese patients with Type 2 diabetes.
                Patients treated with either metformin alone or metformin in combination with sulphonylurea were randomized to double-blind treatment with orlistat or placebo (120 mg) three times daily, combined with a mildly reduced calorie diet and a weight management programme for 52 weeks. Changes in body weight, anthropometry, glycaemic control and lipid profile were assessed.
                After 52 weeks, orlistat-treated patients achieved an almost threefold greater reduction in weight compared with placebo recipients (-5.0% vs. -1.8%; P<0.0001). The decrease in waist circumference was significantly greater with orlistat than placebo (-4.8 cm vs. -2.8 cm; P=0.0022). Orlistat treatment was also associated with significantly greater reductions in haemoglobin A(1c) (-1.1% vs. -0.2%; P<0.0001), fasting plasma glucose (-1.9 mmol/l vs. -0.3 mmol/l; P<0.0001), total cholesterol (-0.2 mmol/l vs. 0.1 mmol/l; P=0.03) and apolipoprotein B (-0.08 g/l vs. 0.01 g/l; P=0.0085) and greater improvements in beta-cell function (P=0.031) and insulin resistance (P=0.001) assessed using the homeostasis model assessment (HOMA). Similar results were obtained for subgroups of patients treated with metformin alone or metformin in combination with sulphonylurea. Orlistat treatment reduced the requirement for anti-diabetic medication more than placebo.
                Orlistat, in combination with a reduced calorie diet and a weight management programme, promotes weight loss and clinically relevant improvements in glycaemic control and other cardiovascular risk factors in obese patients with Type 2 diabetes. The aim of the study was to compare the efficacy of group treatment stressing a health-promoting lifestyle with routine counseling in the treatment of childhood obesity.
                Seventy obese children (weight for height 115-182%) aged 7-9 years were randomized either to routine counseling (two appointments for children) or to family-based group treatment (15 separate sessions for parents and children). These sessions included nutrition education, physical activity education and behavioral therapy.
                Children's weights and heights were measured at baseline, after the 6-month intervention and after the 6-month follow-up. The change of weight for height based on Finnish growth charts was used as the primary, and changes in body mass index (BMI) and BMI standard deviation scores (BMI-SDS) as secondary outcome measures.
                Children attending the group treatment lost more weight for height (6.8%) than children receiving routine counseling (1.8%) (P=0.001). The difference was significant when the data were analyzed in four groups by the cut-off limits of 0, -5 and -10% for the change in weight for height. The respective decreases in BMI were 0.8 vs 0.0 (P=0.003) and in BMI-SDS 0.3 vs 0.2 (P=0.022). The results remained similar in adjusted analyses. Both group and routine programs were feasible with a high, 87-99%, participation rate in sessions and appointments and very low, 3% or less, attrition rate from the programs. Six months after the intervention, beneficial effects were partly lost, but for changes in weight for height and BMI, the differences between the two treatment programs still were significant, and for BMI-SDS, there was a trend.
                Family-based group treatment that stresses a health-promoting lifestyle and is given separately for parents and children, offers an effective mode of therapy to treat obese school-aged children. An open, non-comparative study was carried out to assess the efficacy and toleration profile of sibutramine, a new antiobesity drug, in promoting weight loss in obese type 2 diabetes mellitus subject who failed to reduce weight after strict dietary control. Twenty seven patients completed the study. Sibutramine was started as a single morning dose of 10 mg and was subsequently increased to 15 mg daily if weight loss was not satisfactory. The total duration of the study was twelve weeks with followup at every four weeks. Effect of drug was monitored in terms of weight reduction, changes in body mass index, waist circumference, hip circumference, waist/hip ratio and other metabolic parameters. A fixed dietary prescription and concomitant therapy with drugs, if required and not likely to interfere with the trial therapy, was permitted but was not changed during the study period.
                At the end of 12 week, mean weight reduction in study subjects was 4.16 kg (p < 0.001), the corresponding BMI decreased by 1.6 (p < 0.0001) and hip circumference by 3.68 (p < 0.001). However, there was no significant change in fasting blood glucose and Hb(A1c) values.
                The study indicates sibutramine to be an effective and well tolerated agent leading to significant reduction in parameter of obesity in obese type 2 diabetic subjects. The purpose of this study was to evaluate the effects of a combination weight loss program using intermittent low-calorie diets, energy-controlled meal replacement products, and sibutramine on weight loss, diabetes control, and cardiovascular risk factors in overweight or obese subjects with type 2 diabetes.
                Overweight or obese individuals with type 2 diabetes treated with diet or oral medication were randomly assigned to either a standard therapy or combination therapy group. Both groups received a standardized program to facilitate weight loss. The combination therapy group also received 10-15 mg sibutramine daily, low-calorie diets using meal replacement products for 1 week every 2 months, and between low-calorie diet weeks, once daily use of meal replacement product and snack bars to replace one usual meal and snack. Primary outcome measures were changes in body weight, glycemic control, plasma lipids, blood pressure, pulse, and body composition at 1 year.
                At 1 year, combination therapy, compared with standard therapy, resulted in significantly more weight loss (-7.3 +/- 1.3 kg vs. -0.8 +/- 0.9 kg, P < 0.001) and reduction in HbA(1c) (-0.6 +/- 0.3 vs. 0.0 +/- 0.2%, P = 0.05). Combination therapy resulted in reduced requirement for diabetes medications and decreased fat mass and lean body mass. A 5-kg decrease in weight at 1 year was associated with a decrease of 0.4% in HbA(1c) (P = 0.006). Changes in fasting glucose, lipids, pulse, and blood pressure did not differ between groups.
                This combination weight loss program resulted in greater weight loss and improved diabetes control compared with a standard weight loss program in overweight or obese subjects with type 2 diabetes. Cognitive behavioral therapy (CBT) has efficacy for binge eating disorder (BED) but not obesity. No controlled studies have tested whether adding obesity medication to CBT facilitates weight loss. We performed a randomized, placebo-controlled study of orlistat administered with guided self-help CBT (CBTgsh).
                Fifty obese BED patients were randomly assigned to 12-week treatments of either orlistat plus CBTgsh (120 mg three times a day [t.i.d.]) or placebo plus CBTgsh and were followed in double-blind fashion for 3 months after treatment.
                Seventy-eight percent of patients completed treatments without differential dropout between orlistat+CBTgsh and placebo+CBTgsh. Intent-to-treat remission rates (zero binges for past 28 days on Eating Disorder Examination Interview) were significantly higher for orlistat+CBTgsh than placebo+CBTgsh (64% versus 36%) at posttreatment but not at 3-month follow-up (52% in both). Intent-to-treat rates for achieving 5% weight loss were significantly higher for orlistat+CBTgsh than placebo+CBTgsh at posttreatment (36% versus 8%) and 3-month follow-up (32% versus 8%). Significant and comparable improvements in eating disorder psychopathology and psychological distress occurred in both treatments.
                The addition of orlistat to CBTgsh was associated with greater weight loss than the addition of placebo to CBTgsh. Clinical improvements were generally maintained at 3-month follow-up after treatment discontinuation. OBJECTIVE; Weight loss improves glycemic control, lipid profiles, and blood pressure in patients with type 2 diabetes. However, successful long-term weight loss is difficult for these patients, particularly those treated with insulin. The aim of this study was to assess the effect of orlistat, a gastrointestinal lipase inhibitor, on weight loss, glycemic control, and cardiovascular risk factors in overweight or obese insulin-treated type 2 diabetic patients.
                This study was a 1-year multicenter, randomized, double-blind, placebo-controlled trial of orlistat (120 mg three times a day) or placebo combined with a reduced-calorie diet in overweight or obese adults (BMI 28-40 kg/m(2)) with type 2 diabetes treated with insulin alone or combined with oral agents, but with suboptimal metabolic control (HbA(1c) 7.5-12.0%). Outcome measurements included changes in body weight, glycemic control, blood pressure, and serum lipids. RESULTS; After 1 year, the orlistat group lost significantly more weight (-3.89 +/- 0.3% of baseline body weight, means +/- SE) than the placebo group (-1.27 +/- 0.3%, P < 0.001). Orlistat treatment, compared with placebo, produced greater decreases in HbA(1c) (-0.62 +/- 0.08 vs. -0.27 +/- 0.08%, P = 0.002), fasting serum glucose (-1.63 +/- 0.3 vs. -1.08 +/- 0.3 mmol/l, P = 0.02), and the required doses of insulin and other diabetic medications. Orlistat also produced greater improvements than placebo in serum total cholesterol (P = 0.0002) and LDL cholesterol concentrations (P = 0.001) and LDL/HDL ratio (P = 0.01). CONCLUSIONS; Orlistat therapy produces clinically significant weight loss, with improvements in glycemic control and cardiovascular disease risk factors, in overweight or obese patients with type 2 diabetes who have suboptimal metabolic control with insulin therapy. Sibutramine is a selective serotonin and noradrenaline reuptake inhibitor that is known to reduce body weight. The efficacy of this drug in primary care medicine is currently unknown.
                To study, in a primary healthcare setting, the effect of a standardized non-pharmacological treatment program and 15 mg sibutramine or placebo on long-term weight reduction in obese subjects with a body mass index >or= 30 and < 40 kg/m(2).
                A multicentre, double-blind, placebo-controlled, randomized, parallel group comparison over 54 weeks of continuous therapy.
                33 general practitioners in Germany.
                389 obese patients were recruited of whom 362 were randomized.
                Primary measure was weight reduction at week 54; others included reduction in BMI, waist circumference, waist-hip ratio, blood pressure and blood lipids.
                348 obese subjects were analyzed using an intention-to-treat analysis. Mean weight loss in the sibutramine (S) group was 8.1 +/- 8.2 kg vs. 5.1 +/- 6.5 kg in the placebo (P) group (p < 0.001; Intent-to-treat analysis). More subjects lost more than 5 % and 10 % of initial weight with sibutramine than with placebo (5 %, S: 62.6 %, P: 41.4 %, p < 0.001; 10 %, S: 40.8, P: 19.0 %, p < 0.001). Weight loss was accompanied by an improvement in the lipid profile, in particular, an increase in HDL-cholesterol and a decrease in fasting triglycerides. In both groups, systolic and diastolic blood pressure decreased in those with moderate hypertension and remained unchanged in those with normal blood pressure at baseline. There was a modest increase in heart rate in S (1.9 beats/min) vs. P (- 0.9 beats/min) (p < 0.05).
                Under primary care conditions, sibutramine 15 mg daily proved to be a safe and effective drug for additional weight loss in obese subjects undergoing a comprehensive weight reduction program. Since peers have such an important influence on adolescents, we evaluated the efficacy of adding peer-based 'adventure therapy' to a standard cognitive-behavioral weight control program for overweight adolescents.
                Adolescents (N = 76) aged 13-16 years and 20 to 80% overweight (M = 60.56%, s.d.=15.17%), were randomly assigned to one of two treatment conditions: cognitive-behavioral group treatment with 'adventure therapy' similar to Outward Bound (cognitive-behavioral treatment with peer-enhanced adventure therapy (CBT + PEAT)) or cognitive-behavioral group treatment with aerobic exercise (CBT+EXER). Anthropometric and psychosocial measures were obtained at baseline, at the end of the 16-week intervention, and at 10 months following randomization.
                Adolescents assigned to both treatment conditions demonstrated significant weight loss over time, F = 29.06, df = 2, 53, P < 0.01. Average weight loss did not differ significantly between groups (-5.31 kg for CBT + PEAT and -3.20 kg for CBT + EXER) at the end of treatment. There was a significant difference in the percentage of participants maintaining a minimum 4.5 kg (10 pounds) weight loss (35% in the CBT + PEAT condition vs 12% in the CBT+EXER condition, P = 0.042) 10 months from randomization. We also observed a significant age by treatment group interaction, such that older adolescents randomized to CBT + PEAT demonstrated more than four times the weight loss of older adolescents assigned to CBT + EXER (M = -7.86 kg vs M = -1.72 kg) at the end of treatment.
                Peer-based 'adventure therapy' is a promising adjunct to standard cognitive-behavioral weight control intervention for adolescents, and may be most effective for older adolescents. The objective of this study was to determine whether a generalizable best-practice individualized behavioral intervention reduced BMI z score relative to standard dietetic care among overweight children.
                The design consisted of an assessor-blinded, randomized, controlled trial involving 134 overweight children (59 boys, 75 girls; BMI > or = 98th centile relative to United Kingdom 1990 reference data for children aged 5-11 years) who were randomly assigned to a best-practice behavioral program (intervention) or standard care (control). The intervention used family-centered counseling and behavioral strategies to modify diet, physical activity, and sedentary behavior. BMI z score, weight, objectively measured physical activity and sedentary behavior, fat distribution, quality of life, and height z score were recorded at baseline and at 6 and 12 months.
                The intervention had no significant effect relative to standard care on BMI z score from baseline to 6 months and 12 months. BMI z score decreased significantly in both groups from baseline to 6 and 12 months. For those who complied with treatment, there was a significantly smaller weight increase in those in the intervention group compared with control subjects from baseline to 6 months. There were significant between-group differences in favor of the intervention for changes in total physical activity, percentage of time spent in sedentary behavior, and light-intensity physical activity.
                A generalizable, best-practice individualized behavioral intervention had modest benefits on objectively measured physical activity and sedentary behavior but no significant effect on BMI z score compared with standard care among overweight children. The modest magnitude of the benefits observed perhaps argues for a longer-term and more intense intervention, although such treatments may not be realistic for many health care systems. Obesity is common in children and adolescents with incidence rates increasing both nationally and internationally. Its causes are complex and multifaceted, and obesity is associated with high morbidity and mortality as well as psychological distress. Multidimensional programmes are necessary in the treatment of this chronic disease in order to change eating and physical activity habits. A cognitive-behavioural training programme was developed and evaluated. In combination with diet and exercise, this special group programme that includes well established behavioural methods, was expected to result in long-term weight reduction and decrease of psychological distress in connection with obesity.
                As part of the six week in-patient rehabilitation for children and adolescents at Viktoriastift in Bad Kreuznach, the three-part programme (experimental group, EG) was compared with a programme that differed only in the psychological intervention component (instead of the specific training programme they undertook muscle relaxation training, comparison group, CG).
                In total, 197 children and adolescents between 9 and 19 y-of-age were recruited into the study.
                Somatic (eg weight status), behavioural (eg eating behaviour) and psychological (eg quality of life) outcomes were assessed at five points in time: two weeks before the intervention, at the beginning and end of the programme, as well as six months and one year post-intervention. The study started in spring 1997. Main outcomes will be presented.
                Pre- vs post-intervention-tests showed significant improvements in self-reported eating behaviours for the EG compared with the CG (F=6.38, P<0.05); these changes were independent of age and sex. The weight status measured as the percentage of overweight dependent on height was reduced in both groups immediately after the intervention and at follow-up (F=16.51, P<0.01). Reduction in the prevalence of obesity tended to be higher in the EG than in the CG (15% vs 10%). Self-reported quality of life increased from before the intervention to follow-up more in the EG than in the CG (F=3.27, P=0.08). In all, the acceptance of the behavioural patient education programme was good.
                In summary, evaluation results indicate that the cognitive-behavioural training programme is a promising approach to alter obesity-related habits and to reduce somatic and psychosocial consequences. Long-term effects after two years are expected to underscore these results. It is well established that the risk of developing type 2 diabetes is closely linked to the presence and duration of overweight and obesity. A reduction in the incidence of type 2 diabetes with lifestyle changes has previously been demonstrated. We hypothesized that adding a weight-reducing agent to lifestyle changes may lead to an even greater decrease in body weight, and thus the incidence of type 2 diabetes, in obese patients.
                In a 4-year, double-blind, prospective study, we randomized 3,305 patients to lifestyle changes plus either orlistat 120 mg or placebo, three times daily. Participants had a BMI >/=30 kg/m2 and normal (79%) or impaired (21%) glucose tolerance (IGT). Primary endpoints were time to onset of type 2 diabetes and change in body weight. Analyses were by intention to treat.
                Of orlistat-treated patients, 52% completed treatment compared with 34% of placebo recipients (P < 0.0001). After 4 years' treatment, the cumulative incidence of diabetes was 9.0% with placebo and 6.2% with orlistat, corresponding to a risk reduction of 37.3% (P = 0.0032). Exploratory analyses indicated that the preventive effect was explained by the difference in subjects with IGT. Mean weight loss after 4 years was significantly greater with orlistat (5.8 vs. 3.0 kg with placebo; P < 0.001) and similar between orlistat recipients with impaired (5.7 kg) or normal glucose tolerance (NGT) (5.8 kg) at baseline. A second analysis in which the baseline weights of subjects who dropped out of the study was carried forward also demonstrated greater weight loss in the orlistat group (3.6 vs. 1.4 kg; P < 0.001).
                Compared with lifestyle changes alone, orlistat plus lifestyle changes resulted in a greater reduction in the incidence of type 2 diabetes over 4 years and produced greater weight loss in a clinically representative obese population. Difference in diabetes incidence was detectable only in the IGT subgroup; weight loss was similar in subjects with IGT or NGT [correction]. Orlistat, a gastrointestinal lipase inhibitor that reduces dietary fat absorption by approximately 30%, may promote weight loss and reduce cardiovascular risk factors.
                To test the hypothesis that orlistat combined with dietary intervention is more effective than placebo plus diet for weight loss and maintenance over 2 years.
                Randomized, double-blind, placebo-controlled study conducted from October 1992 to October 1995.
                Obese adults (body mass index [weight in kilograms divided by the square of height in meters], 30-43 kg/m2) evaluated at 18 US research centers.
                Subjects received placebo plus a controlled-energy diet during a 4-week lead-in. On study day 1, the diet was continued and subjects were randomized to receive placebo 3 times a day or orlistat, 120 mg 3 times a day, for 52 weeks. After 52 weeks, subjects began a weight-maintenance diet, and the placebo group (n = 133) continued to receive placebo and orlistat-treated subjects were rerandomized to receive placebo 3 times a day (n = 138), orlistat, 60 mg (n = 152) or 120 mg (n = 153) 3 times a day, for an additional 52 weeks.
                Body weight change and changes in blood pressure and serum lipid, glucose, and insulin levels.
                A total of 1187 subjects entered the protocol, and 892 were randomly assigned on day 1 to double-blind treatment. For intent-to-treat analysis, 223 placebo-treated subjects and 657 orlistat-treated subjects were evaluated. During the first year orlistat-treated subjects lost more weight (mean +/- SEM, 8.76+/-0.37 kg) than placebo-treated subjects (5.81+/-0.67 kg) (P<.001). Subjects treated with orlistat, 120 mg 3 times a day, during year 1 and year 2 regained less weight during year 2 (3.2+/-0.45 kg; 35.2% regain) than those who received orlistat, 60 mg (4.26+/-0.57 kg; 51.3% regain), or placebo (5.63+/-0.42 kg; 63.4% regain) in year 2 (P<.001). Treatment with orlistat, 120 mg 3 times a day, was associated with improvements in fasting low-density lipoprotein cholesterol and insulin levels.
                Two-year treatment with orlistat plus diet significantly promotes weight loss, lessens weight regain, and improves some obesity-related disease risk factors. Obesity is an important risk factor for type 2 diabetes. Weight loss in patients with type 2 diabetes is associated with improved glycemic control and reduced cardiovascular disease risk factors, but weight loss is notably difficult to achieve and sustain with caloric restriction and exercise. The purpose of this study was to assess the impact of treatment with orlistat, a pancreatic lipase inhibitor, on weight loss, glycemic control, and serum lipid levels in obese patients with type 2 diabetes on sulfonylurea medications.
                In a multicenter 57-week randomized double-blind placebo-controlled study, 120 mg orlistat or placebo was administered orally three times a day with a mildly hypocaloric diet to 391 obese men and women with type 2 diabetes who were aged > 18 years, had a BMI of 28-40 kg/m2, and were clinically stable on oral sulfonylureas. Changes in body weight, glycemic control, lipid levels, and drug tolerability were measured.
                After 1 year of treatment, the orlistat group lost 6.2 +/- 0.45% (mean +/- SEM) of initial body weight vs. 4.3 +/- 0.49% in the placebo group (P < 0.001). Twice as many patients receiving orlistat (49 vs. 23%) lost > or = 5% of initial body weight (P < 0.001). Orlistat treatment plus diet compared with placebo plus diet was associated with significant improvement in glycemic control, as reflected in decreases in HbA1c (P < 0.001) and fasting plasma glucose (P < 0.001) and in dosage reductions of oral sulfonylurea medication (P < 0.01). Orlistat therapy also resulted in significantly greater improvements than placebo in several lipid parameters, namely, greater reductions in total cholesterol, (P < 0.001), LDL cholesterol (P < 0.001), triglycerides (P < 0.05), apolipoprotein B (P < 0.001), and the LDL-to-HDL cholesterol ratio (P < 0.001). Mild to moderate and transient gastrointestinal events were reported with orlistat therapy, although their association with study withdrawal was low. Fat-soluble vitamin levels generally remained within the reference range, and vitamin supplementation was required in only a few patients.
                Orlistat is an effective treatment modality in obese patients with type 2 diabetes with respect to clinically meaningful weight loss and maintenance of weight loss, improved glycemic control, and improved lipid profile. To evaluate the efficacy of orlistat to enhance weight loss in obese adolescents.
                The study was a 6-month randomized, double-blind, placebo-controlled trial to compare the effects of orlistat (120 mg orally 3 times a day) and placebo on reduction of body mass index (BMI). Forty adolescents between 14 and 18 years of age with a mean BMI of 40 kg/m2 entered the protocol between December 2002 and February 2003. Study subjects stayed overnight in the General Clinical Research Center, during which dietary records were reviewed and lifestyle recommendations were given. The study participants received either orlistat (120 mg orally 3 times a day) or placebo and were assessed monthly for 6 months. At 0, 3, and 6 months, fasting laboratory tests were performed. The primary end point was the change in BMI from baseline to 6 months. Secondary outcomes included changes in weight, lean body mass, and results of blood chemistry studies.
                No statistically significant difference was noted between the 2 study groups for decrease in BMI from baseline to 6 months (P = 0.39). The decrease in BMI within the orlistat group (-1.3 +/- 1.6 kg/m2; P = 0.04) and within the placebo group (-0.8 +/- 3.0 kg/m2; P = 0.02), however, was statistically significant. Laboratory measurements did not differ between the 2 groups. In comparison with the placebo group, the orlistat group had increased adverse events, primarily gastrointestinal symptoms and findings.
                In this study of obese adolescents, orlistat did not significantly reduce BMI in comparison with placebo at 6 months. This study evaluates the post-treatment and short-term follow-up efficacy of, as well as participant satisfaction for, a 4-month behavioral weight control program for overweight adolescents initiated in a primary care setting and extended through telephone and mail contact.
                44 overweight adolescents were randomly assigned to either a multiple component behavioral weight control intervention (Healthy Habits [HH]; n = 23) or a single session of physician weight counseling (typical care [TC]; n = 21). Weight, height, dietary intake, physical activity, sedentary behavior, and problematic weight-related and eating behaviors and beliefs were assessed before treatment, after the 4-month treatment, and at 3-month follow-up. Participant satisfaction and behavioral skills use were measured.
                HH adolescents evidenced better change in body mass index z scores to post-treatment than TC adolescents. Body mass index z scores changed similarly in the conditions from post-treatment through follow-up. Behavioral skills use was higher among HH than TC adolescents, and higher behavioral skills use was related to better weight outcome. Energy intake, percentage of calories from fat, physical activity, sedentary behavior, and problematic weight-related or eating behaviors/beliefs did not differ by condition or significantly change over time independent of condition. The behavioral intervention evidenced good feasibility and participant satisfaction.
                A telephone- and mail-based behavioral intervention initiated in primary care resulted in better weight control efficacy relative to care typically provided to overweight adolescents. Innovative and efficacious weight control intervention delivery approaches could decrease provider and participant burden and improve dissemination to the increasing population of overweight youth. Parent-child treatments have been shown to be superior to child-focused treatments of childhood obesity. Yet until now, the comparative effectiveness of parent-only and parent-child approaches has been little studied.
                Fifty-six obese children and their families were randomly assigned to a 16-session cognitive behavioral therapy (CBT) for the parents only or for a combined treatment of parents and children. Children's percent overweight, the body mass index of their mothers, and behavioral and psychological problems of children and mothers were assessed.
                Both treatments reduced children's percent overweight significantly and equally by 6-month follow-up. Also both treatments provided similar results in reducing general behavior problems (externalizing and internalizing behavior problems), global and social anxiety, and depression.
                Our results point to a comparable efficacy of the two treatments. Further, psychological well-being of both mothers and children can be improved in a CBT for obese children and their parents. Future studies should focus on finding ways to improve the adherence of families to long-term treatment of obesity in childhood.
                (c) 2008 S. Karger AG, Basel. Family-based, behavioral treatment has been shown to be an effective intervention for the management of pediatric obesity. The goal of this study was to compare the cost-effectiveness of two protocols for the delivery of family-based behavioral treatment.
                Thirty-one families with obese children were randomized to groups in which families were provided mixed treatment incorporating both group and individualized treatment vs group treatment only. Cost-effectiveness of treatment was defined as the magnitude of reduction in standardized BMI and percentage overweight per dollar spent for recruitment and treatment. Anthropometric data were assessed at baseline, 6 months and 12 months post-randomization.
                Results for the 24 families with complete data showed the group intervention was significantly more cost-effective than the mixed treatment. This was due to the similarity between the two groups in Z-BMI or percentage overweight change for children and their parents, while the mixed treatment was significantly more expensive to deliver than the group treatment.
                These findings suggest that a family-based, behavioral intervention employing group treatment alone is a more cost-effective approach to treating pediatric obesity than a mixed group plus individual format. In Germany the number of children with elevated body weights has significantly increased in the last 10 to 15 years. Resulting comorbidities lead to increasing costs for the community. The quality of life of these children is reduced.
                84 children and their families have been included in the study. In addition to anthropometric data informations on eating behaviour and psychosocial data of the family have been documented. At the beginning of the intervention the children had an age of 10.36 +/- 3,27 years and a BMI-SDS of 4,78 +/- 1,16. The mean time period for follow-up has been 28,7 months (mean).
                Children have been treated within a family-based intervention program in a setting focusing on behaviour modification over 6 months (sessions every 4 th week). Patients have been treated in four different intervention groups (behaviour modification and eating counselling (a),a' plus one parent group session (b),b' plus two courses in cooking and preparing meals for parents and children, (c), the fourth group has been treated in addition within a more intensive inpatient setting for 6 weeks.
                Drop out rate has been 37,1 %. The weight reduction during the treating period has resulted in a reduction of the BMI-SDS of 0.57 +/- 0.51 (p = 0.0001). 33.7 % of the patients investigated during follow-up (n = 30) have not changed or even reduced their achieved body weights (BMI-SDS). In a stepwise multiple regression analysis the variables age of the patient, self-control of eating behavior and weight of the father explained 70 % of the variance of weight changes during the follow-up period. There have been no differences between the changes in BMI-SDS during follow-up between patients in groups,a',b' or,c' and the group taking part in addition in the in-patient setting.
                Treatment programs for obese children and adolescents have to focus on the specific living conditions and eating behaviours of the family especially on age, capacity for self control of the child and the eating behaviour of the father. Local networks to be established within the country for treating obese children coordinated by the paediatrician seem to be best possibilities to provide individual support. In this local networks the prevention of extreme eight increases must be a predominant task. Obesity and diabetes have caused problems for individuals with schizophrenia long before atypical antipsychotic agents. The prevalence of obesity, insulin resistance, impaired glucose tolerance, type 2 diabetes mellitus, dyslipidemia, and the Metabolic Syndrome has increased in people with schizophrenia as compared to the general population. Risk reduction studies for persons with obesity, diabetes, and cardiovascular disease indicate that cognitive/behavioral interventions that promote motivation and provide strategies to overcome the barriers in adherence to diet and activity modification are effective interventions for weight management and risk reduction. In the landmark multi-center randomized-controlled trial study, the Diabetes Prevention Project (DPP), a cognitive/behavioral intervention, was more successful in producing weight loss and preventing diabetes than the drugs metformin, troglitazone or placebo. This pilot study examined the effectiveness of a cognitive/behavioral group intervention, modified after the DPP program, in individuals with schizophrenia or schizoaffective disorder taking atypical antipsychotics in a large urban public mental health system. Outcome measures included body weight, body mass index, waist-hip ratios, and fasting glucose levels. Both groups demonstrated elevated fasting glucose levels and were obese with a mean BMI of 33. The group that received the cognitive/behavioral group intervention lost more weight than the treatment as usual group. The CB group participants lost an average of 5.4 lb or 2.9% of body weight, and those in the control group lost 1.3 lb or 0.6% body weight. The range of weight loss for the treatment group was from 1 to 20 lb. This pilot study has demonstrated that weight loss is possible with cognitive/behavioral interventions in a population with a psychotic disorder. The prevalence of overweight and obesity in children and adolescents is increasing in both the United States and Mexico.
                The goal of this article was to assess the efficacy and safety of sibutramine in obese Mexican adolescents.
                This was a 6-month, randomized, double-blind, placebo-controlled, prospective clinical trial of sibutramine QD. Male and female patients aged 14 to 18 years with sex-specific body mass index (BMI) for age and sex >85th percentile were eligible. The primary end points for the trial were the baseline versus end point absolute values for body weight, BMI, and percentage of the initial BMI (%BMI); secondary end points were waist circumference and percentage of the initial waist circumference (%waist). These were measured at days -15, 0, 30, 60, 90, 120, 150, and 180 of the study. Quality of life was assessed at the study start and end using the 36-Item Short-Form Health Survey (SF-36) questionnaire. Blood pressure and heart rate were assessed, and adverse events (AEs) were recorded. Both groups received individually tailored diet and exercise programs.
                Forty-six patients (age range, 14-18 years) with a BMI >95th percentile for age were included (sibutramine group, n = 23 [14 females, 9 males]; placebo group, n = 23 [12 females, 11 males]). Twenty-one patients in the sibutramine group and 19 patients in the placebo group completed the 6-month trial. Using the intent-to-treat data, weight (mean [SD]) in the sibutramine group changed from 92.5 (14.6) kg to 85.7 (14.4) kg, for a net weight loss of 7.3 kg (95% CI 4.6-9.9), a waist circumference loss of 8.0 cm (95% CI, 4.7-11.3), and a % BMI loss of 9.2% (95% CI, 6.9-11.6). In the placebo group, weight changed from 98.9 (22.7) kg to 94.6 (22.5) kg, a weight loss of 4.3 kg (95% CI, 1.7-6.9), a waist circumference loss of 3.8 cm (95% CI, 0.7-7.0), and a %BMI loss of 5.2% (95% CI, 2.4-7.9) (P < 0.05 for all intragroup comparisons; P > 0.05 for the intergroup comparisons). Mean (SD) scores on the SF-36 scale in the sibutramine group changed from 78.0 (13.3) at baseline to 84.8 (7.4) at study end (P < 0.05); the respective values in the placebo group were 82.8 (10.3) and 87.3 (7.6) (P < 0.05). At base-line, systolic blood pressure (SBP) was 116.7 (5.9) mm Hg in the sibutramine group and 118.3 (7.6) mm Hg in the placebo group; at end point, the respective SBPs were 112.4 (9.6) mm Hg and 112.6 (6.5) mm Hg. At baseline, diastolic blood pressure (DBP) was 78.9 (4.5) mm Hg in the sibutramine group and 79.5 (5.2) mm Hg in the placebo group; at end point, the respective DBPs were 73.5 (6.3) mm Hg and 76.6 (6.2) mm Hg. At baseline, heart rate was 76.3 (6.4) beats/min in the sibutramine group and 81.1 (9.5) beats/min in the placebo group; at end point, the respective findings were 79.8 (8.8) beats/min and 77.6 (8.6) beats/min (P > 0.05 for all preceding intergroup comparisons). One patient in the sibutramine group had increased blood pressure (at month 3) and 3 had increased heart rate (at months 1, 2, and 4); 2 patients receiving placebo had increased blood pressure (month 3) and 2 had increased heart rate (at months 1 and 3). These changes disappeared in 1 week and did not require treatment or trial suspension. Additionally, in the sibutramine group, 3 patients experienced 4 mild AEs: headache, dry mouth, headache with nausea, and headache with weakness and paleness (P > 0.05). In the placebo group, 3 patients experienced 4 mild AEs: 2 cases of headache, as well as 1 case of headache with somnolence and 1 case of headache with dry mouth (P > 0.05).
                Sibutramine 10 mg QD in addition to diet and exercise was effective and generally well tolerated in this population of obese Mexican adolescents. There is a consensus that interventions to prevent and treat childhood obesity should involve the family; however, the extent of the child's involvement has received little attention. The goal of the present study was to evaluate the relative efficacy of treating childhood obesity via a family-based health-centred intervention, targeting parents alone v. parents and obese children together. Thirty-two families with obese children of 6-11 years of age were randomised into groups, in which participants were provided for 6 months a comprehensive educational and behavioural programme for a healthy lifestyle. These groups differed in their main agent of change: parents-only v. the parents and the obese child. In both groups, parents were encouraged to foster authoritative parenting styles (parents are both firm and supportive; assume a leadership role in the environmental change with appropriate granting of child's autonomy). Only the intervention aimed at parents-only resulted in a significant reduction in the percentage overweight at the end of the programme (P=0.02) as well as at the 1-year follow-up meeting. The differences between groups at both times were significant (P<0.05). A greater reduction in food stimuli in the home (P<0.05) was noted in the parents-only group. In both groups, the parents' weight status did not change. Regression analysis shows that the level of attendance in sessions explained 28 % of the variability in the children's weight status change, the treatment group explained another 10 %, and the improvement in the obesogenic load explained 11 % of the variability. These results suggest that omitting the obese child from active participation in the health-centred programme may be beneficial for weight loss and for the promotion of a healthy lifestyle among obese children. To investigate whether the satiety-inducing agent sibutramine affected body weight and associated anthropometry in overweight and obese (body mass index (BMI) > 27) Type 2 diabetic patients on sulphonylurea therapy.
                A randomized, placebo-controlled trial was undertaken in 134 patients with stable metabolic control on chronic sulphonylurea therapy. Patients were placed on moderate caloric restriction and received treatment with either sibutramine (15 mg/day) or placebo for 6 months.
                Fifty-three of 69 sibutramine-treated and 57/65 placebo-treated patients completed the study. Both groups showed progressive weight loss. At the end of the trial weight loss was two times greater in the sibutramine group (mean +/- SEM; -4.5 +/- 0.5 kg) than placebo (-1.7 plus minus 0.5 kg, P < 0.001 vs. sibutramine). There was a trend for more patients to lose > 5% of initial body weight in the sibutramine group than placebo. BMI (P < 0.001) and waist circumference (P < 0.001) were also decreased to a greater extent by sibutramine. Mean reductions in HbA(1c) were commensurate with weight loss in both the sibutramine and placebo (- 0.78 +/- 0.17% and -0.73 +/- 0.23%; P = 0.84). Sibutramine was well tolerated with only two patients withdrawn due to potentially drug-related serious adverse events (palpitations).
                Sibutramine, in conjunction with moderate caloric restriction, enhances weight loss and reduces waist circumference in overweight and obese Type 2 diabetic patients receiving sulphonylurea therapy. This is associated with additional improvements in glycaemic control in a limited number of patients losing > or = 10% of their baseline body weight. The management of type 2 diabetes mellitus is complicated by the presence of risk factors related to overweight and obesity, particularly visceral adiposity. However, weight loss and weight maintenance are difficult for patients with diabetes, and the benefits of dietary modifications are typically modest. Sibutramine is a serotonin- and norepinephrine-reuptake inhibitor that reduces food intake by inducing early satiety and attenuates the decrease in basal energy expenditure associated with weight loss. Previous trials of sibutramine in overweight and obese patients with type 2 diabetes have shown significant weight loss accompanied by better glycemic control.
                The goal of this study was to assess the effect on body weight and glycemic control of sibutramine in combination with glibenclamide in obese Hispanic patients with type 2 diabetes.
                This was a 12-month, randomized, double-blind, placebo-controlled clinical trial conducted at the Endocrinology Service, General Hospital of Mexico, Mexico City. Included were overweight or obese (body mass index [BMI] >27 kg/M2) patients with type 2 diabetes between the ages of 24 and 65 years who had been receiving glibenclamide monotherapy for at least 2 weeks and whose glucose concentrations were stable. Patients were randomized to receive sibutramine 10 mg or placebo once daily. The primary efficacy measures were change in body weight, waist circumference, and glycosylated hemoglobin (HbA1c). Anthropometrics and fasting glucose concentrations were measured monthly. HbA1c was determined at baseline and at 6 and 12 months. Laboratory parameters were measured at baseline and at the end of the study.
                Forty-four patients were randomized to receive sibutramine (28 women, 16 men; mean [SD] age, 47.6 [9.0] years), and 42 were randomized to receive placebo (31 women, 11 men; mean age, 45.8 [8.1] years). Twenty-four patients in the sibutramine group and 23 in the placebo group completed the trial. In the sibutramine group, body weight was reduced from a mean (SD) of 73.9 (10.3) kg at baseline to 69.8 (10.6) kg at month 12; BMI decreased from 29.9 (2.6) to 28.2 (2.9) kg/M2; waist circumference was reduced from 94.9 (8.4) to 90.8 (8.4) cm; the plasma fasting glucose concentration decreased from 140.4 (29.4) to 114.2 (32.0) mg/dL; and the HbA1c value was reduced from 8.9% (1.2) to 8.3% (1.2) (all, P < 0.001). In the placebo group, the corresponding changes were from 74.5 (10.3) kg at baseline to 73.1 (11.2) kg at month 12; from 30.1 (2.5) to 29.5 (2.9) kg/M2; from 94.4 (7.3) to 93.1 (8.3) cm (P < 0.05); from 140.7 (25.2) to 123.9 (38.3) mg/dL (P < 0.05); and from 9.0% (1.2) to 9.1% (1.3). In the sibutramine group, weight loss continued for up to 12 months.
                In this population of obese Hispanic patients with type 2 diabetes, sibutramine combined with glibenclamide therapy achieved weight loss for up to 12 months and was associated with better glycemic control than placebo. This study examined the reduction in overweight and changes in eating-related behaviours in obese children treated with a family-based approach, in which the parents were the exclusive agents of change. Results were compared to the conventional approach in which children are responsible for their own weight loss.
                A one-year longitudinal prospective design was used. Participants were randomly allocated for the experimental (parents as the agents of change) or the conventional (children as the agents of change) intervention.
                Sixty obese children (20% over ideal weight for age, height and gender) aged 6-11 y (mean+/-s.d. 9.2+/-1.0 y) were included in the study. Anthropometric measurements and biochemical tests were performed on the children and their parents before and after the programme, and both parents completed a sociodemographic and a family eating and activity habits questionnaire. Hour-long support/educational sessions were conducted by a clinical dietitian-14 sessions for the parents in the experimental intervention and 30 for the children in the conventional intervention. Individual sessions were held for members of both groups, when necessary.
                Significant differences were found between the two groups in the reduction of exposure to food stimuli and changes in eating habits (eating while standing, watching TV, reading or doing homework, eating following stress and eating between meals). Mean weight reduction (by percentile) was significantly greater in the experimental intervention group (parent-only treatment) in comparison to the conventional intervention group (child-only treatment).
                Treatment of childhood obesity with the parents as the exclusive agents of change, induces more behavioural changes as well as greater weight loss, than the conventional approach. We undertook a randomised controlled trial to assess the efficacy and tolerability of orlistat, a gastrointestinal lipase inhibitor, in promoting weight loss and preventing weight regain in obese patients over a 2-year period.
                743 patients (body-mass index 28-47 kg/m2), recruited at 15 European centres, entered a 4-week, single-blind, placebo lead-in period on a slightly hypocaloric diet (600 kcal/day deficit). 688 patients who completed the lead-in were assigned double-blind treatment with orlistat 120 mg (three times a day) or placebo for 1 year in conjunction with the hypocaloric diet. In a second 52-week double-blind period patients were reassigned orlistat or placebo with a weight maintenance (eucaloric) diet.
                From the start of lead-in to the end of year 1, the orlistat group lost, on average, more bodyweight than the placebo group (10.2% [10.3 kg] vs 6.1% [6.1 kg]; LSM difference 3.9 kg [p<0.001] from randomisation to the end of year 1). During year 2, patients who continued with orlistat regained, on average, half as much weight as those patients switched to placebo (p<0.001). Patients switched from placebo to orlistat lost an additional 0.9 kg during year 2, compared with a mean regain of 2.5 kg in patients who continued on placebo (p<0.001). Total cholesterol, low-density lipoprotein (LDL) cholesterol, LDL/high-density lipoprotein ratio, and concentrations of glucose and insulin decreased more in the orlistat group than in the placebo group. Gastrointestinal adverse events were more common in the orlistat group. Other adverse symptoms occurred at a similar frequency during both treatments.
                Orlistat taken with an appropriate diet promotes clinically significant weight loss and reduces weight regain in obese patients over a 2-year period. The use of orlistat beyond 2 years needs careful monitoring with respect to efficacy and adverse events. Evaluated the effects of a 10-month inpatient treatment program and implemented as a nondiet healthy lifestyle approach. In addition, the effects of two extended treatment programs were compared to a standard cognitive-behavioral treatment program for maintenance of the treatment gains.
                A within-subjects design was employed to evaluate treatment outcome, including a 14-month follow-up. Children (N = 122) ranged in age from 7 to 17 years (M = 12.7 years) with a mean Body Mass Index (BMI) of 32.5, expressed as a percentage of overweight (M = 77.4%).
                The children lost 49.0% of their weight during the course of treatment. Comparing baseline with the 14-month follow-up, a weight loss of 31.7% was maintained. The children continued to show healthy eating behavior at follow-up, and their psychological well-being had improved. No significant interaction effects were found for the extended coping programs.
                An inpatient cognitive-behavioral nondiet approach is a promising treatment option for childhood obesity, with lasting effects throughout the 14-month posttreatment. To assess the efficacy of a school-based intervention programme to reduce the prevalence of overweight in 6 to 10-year-old children.
                Cluster-randomized, controlled study.
                A total of 3135 boys and girls in grades 1-4 were included in the study.
                Ten schools were selected in Stockholm county area and randomized to intervention (n=5) and control (n=5) schools. Low-fat dairy products and whole-grain bread were promoted and all sweets and sweetened drinks were eliminated in intervention schools. Physical activity (PA) was aimed to increase by 30 min day(-1) during school time and sedentary behaviour restricted during after school care time. PA was measured by accelerometry. Eating habits at home were assessed by parental report. Eating disorders were evaluated by self-report.
                The prevalence of overweight and obesity decreased by 3.2% (from 20.3 to 17.1) in intervention schools compared with an increase of 2.8% (from 16.1 to 18.9) in control schools (P<0.05). The results showed no difference between intervention and controls, after cluster adjustment, in the longitudinal analysis of BMIsds changes. However, a larger proportion of the children who were initially overweight reached normal weight in the intervention group (14%) compared with the control group (7.5%), P=0.017. PA did not differ between intervention and control schools after cluster adjustment. Eating habits at home were found to be healthier among families with children in intervention schools at the end of the intervention. There was no difference between children in intervention and control schools in self-reported eating disorders.
                A school-based intervention can reduce the prevalence of overweight and obesity in 6 to 10-year-old children and may affect eating habits at home. The effect of the intervention was possibly due to its effect on healthy eating habits at school and at home rather than on increased levels of PA. The increasing prevalence of overweight and obesity underscores the need for evidence-based, easily disseminable interventions for weight management that can be delivered on a population basis. The Transtheoretical Model (TTM) offers a promising theoretical framework for multiple behavior weight management interventions.
                Overweight or obese adults (BMI 25-39.9; n=1277) were randomized to no-treatment control or home-based, stage-matched multiple behavior interventions for up to three behaviors related to weight management at 0, 3, 6, and 9 months. All participants were re-assessed at 6, 12, and 24 months.
                Significant treatment effects were found for healthy eating (47.5% versus 34.3%), exercise (44.90% versus 38.10%), managing emotional distress (49.7% versus 30.30%), and untreated fruit and vegetable intake (48.5% versus 39.0%) progressing to Action/Maintenance at 24 months. The groups differed on weight lost at 24 months. Co-variation of behavior change occurred and was much more pronounced in the treatment group, where individuals progressing to Action/Maintenance for a single behavior were 2.5-5 times more likely to make progress on another behavior. The impact of the multiple behavior intervention was more than three times that of single behavior interventions.
                This study demonstrates the ability of TTM-based tailored feedback to improve healthy eating, exercise, managing emotional distress, and weight on a population basis. The treatment produced a high level of population impact that future multiple behavior interventions can seek to surpass. To compare two strategies for childhood obesity management: ambulatory assistance (individual) and educational program (in group).
                Children and adolescents from 7 to 13 years of age were selected at random. They were divided into two groups: individually assisted or assisted in groups. An educational program about childhood obesity was created, with monthly meetings that consisted of lectures with parents' participation and group work. Simultaneously, children and teenagers of the other group received individual ambulatory assistance. The program took place for six months. Body composition, eating habits and physical activities were assessed before and after interventions.
                The sample comprised 38 children and adolescents whose mean age was 9.9 years. The program was more effective in increasing physical activity (p = 0.003), specially walking (p = 0.003), as well as in reducing total cholesterol (p = 0.038). Reduction of body mass index, obesity index and caloric intake was similar in both groups. As for food habits, ambulatory assistance increased the intake of fruits (p = 0.033) and vegetables (p = 0.002) and reduced the amount of French fries and crisps (p = 0.041), while children participating in the program reduced the intake of soft drinks (p = 0.022), sandwiches, pizza and fast food (p = 0.006).
                Both strategies for handling childhood obesity were favorable to changes in food and physical activity habits. Group assistance was as effective as individual assistance, consolidating it as an alternative for obesity treatment. The researchers assessed the long-term weight reduction efficacy, tolerability, and safety of sibutramine used once daily in conjunction with behavior modification to treat mild to moderate obesity.
                This was a double-blind randomized placebo-controlled parallel-group comparative study of sibutramine 10 mg or 15 mg (or placebo) once daily for 1 year, given with dietary advice.
                A total of 485 obese men and women with uncomplicated obesity were included (mean age=42 years, mean body mass index=32.7 kg/m2).
                The outcomes were mean weight loss, percentage losing more than 5% or 10% of their body weight, and adverse drug effects.
                Among patients completing the study, those taking sibutramine 10 mg or 15 mg had greater mean weight loss compared with placebo at 12-month assessment (P < or = .001). Changes in body weight from baseline to end point were -1.6 kg for those taking placebo, -4.4 kg for those taking sibutramine 10 mg (P < or =.01, last observation carried forward [LOCF]), and -6.4 kg for those taking sibutramine 15 mg (P < or =.001, LOCF). For placebo patients, 20% lost 5% or more of their body weight compared with 39% of patients taking sibutramine 10 mg and 57% taking sibutramine 15 mg. Only 7% of the patients taking placebo lost 10% or more of their body weight, compared with 19% taking sibutramine 10 mg and 34% taking sibutramine 15 mg (P <.001 for both 10 mg and 15 mg vs placebo, and for both > or =5% and > or =10%).
                Sibutramine 10 mg or 15 mg once daily given with dietary advice produces and maintains statistically and clinically significantly greater weight loss than dietary advice alone (placebo) throughout a 12-month treatment period, and is safe and well tolerated. To assess the efficacy and tolerability of sibutramine 15 mg once daily as a weight reduction agent in overweight and obese patients (body mass index (b.m.i.) > 26 kg/m2) with type 2 diabetes when given with a customised, reduced-calorie diet, and to evaluate the influence of weight loss on diabetic control.
                Randomised, placebo-controlled, double-blind, parallel-group, 12-week study conducted at two hospital-based obesity/diabetes clinics. Patients were men and women aged 30-65 years, with b.m.i. > 26 kg/m2 and < or = 35 kg/m2 and treated or untreated type 2 diabetes diagnosed > or = 6 months previously. Each patient was given sibutramine 15 mg or placebo once daily and advised to follow a customised diet of 500 kcal/day less than the individual's energy needs. The principal measure of efficacy was change in body weight (b.w.). Additional efficacy measurements were changes in b.m.i., body composition as measured by dual-energy X-ray absorptiometry, and change in waist and hip measurements. Changes in diabetic control were assessed by blood glucose levels fasting and after a standard test meal, fasting insulin level, and glycosylated haemoglobin level. Adverse events (AEs) were monitored at each visit, and routine laboratory safety tests were done at 4-week intervals.
                Ninety-one patients were randomised into the study, 44 to placebo and 47 to sibutramine 15 mg once daily. Eighty-three patients (91%) completed the study, 40 (91%) on placebo and 43 (91%) on sibutramine. Mean weight reduction from baseline was statistically significantly greater with sibutramine than with placebo at every measurement and at the end of the study (2.4 vs. 0.1 kg at week 12; p < 0.001; intent-to-treat). The proportion of patients who lost > 5% of their baseline b.w. was 19% in the sibutramine group and 0% in the placebo group (p < 0.001; 95% confidence interval: 9, 30). Patients receiving sibutramine lost significantly more fat mass compared with those receiving placebo, as a percentage (1.0% vs. 0.1%; p < 0.05) and in absolute terms (1.8 vs. 0.2 kg, p < 0.001). Loss of lean mass was not significantly different between the groups. Mean peak blood glucose concentration after a standard test meal decreased by 1.1 mmol/l in the sibutramine treatment group but increased by 0.5 mmol/l in the placebo group (p = 0.04; difference in means, 1.6, 95% confidence interval: -3.3, -0.1). Mean fasting blood glucose decreased by 0.3 mmol/l with sibutramine and increased by 1.4 mmol/l with placebo. Mean glycosylated haemoglobin levels decreased by 0.3% units with sibutramine treatment, and were unchanged with placebo. However, more sibutramine-treated patients (33%) than placebo-treated patients (5%) achieved decreases in glycosylated haemoglobin of 1% unit or more (p < 0.05). Sibutramine 15 mg was safe and well tolerated, and AEs were mostly mild or moderate in severity. No significant differences were found between treatment groups in blood pressure. No clinically significant conduction or rhythm abnormalities were observed on ECG.
                Sibutramine 15 mg once daily with a customised, reduced-calorie diet significantly reduced weight compared with placebo in overweight and obese patients (b.m.i. > 26 kg/m2) with type 2 diabetes. Sibutramine was well tolerated, and significant improvement in diabetic control was seen in conjunction with weight reduction on sibutramine treatment. This study investigated the effectiveness of cognitive self-management training as an adjunct to the behavioural management of childhood obesity. Twenty-seven overweight children aged 7-13 years were randomly assigned to either behavioural management plus relaxation placebo or a combined behavioural-cognitive self-management approach. Evaluations following the eight treatment sessions revealed a significant reduction in percentage overweight for children in both experimental groups and improvements were maintained at 3- and 6-month follow-ups. Both conditions were also effective in reducing the number of high-risk foods consumed. No difference in outcome was found between treatments at the post-treatment assessment or 3- and 6-month follow-ups. Although a reduction in percentage overweight of around 9% was found for both procedures, subjects in general remained considerably overweight. To determine if a multi-component family focused education package is more effective than a waiting list control group in treating overweight and obese children.
                A 2-year randomised controlled trial; 65 overweight and obese children aged 6-14 years were allocated to active intervention in either the first or second year, with body composition monitoring alone in the control period. Anthropometric measurements were undertaken at six monthly intervals and a 7-day food and activity diary were issued.
                Over the 2 years of the study body mass index (BMI) SDS (z score) fell significantly in the intervention/control (I/C) group, but not in the control/intervention (C/I) group. The difference between groups was 0.3, which was borderline significant (95% confidence interval (95% CI) -0.62 to 0.02, P=0.06) before adjusting for potential confounding factors. Thirty-three percent of the I/C group and 12% of the C/I group achieved the target reduction of 0.5 BMI SDS. The I/C group had a significantly greater reduction in the percentage with a BMI above the 99.6th centile at 24 months (P=0.04) and gained 5.7 kg less over the time of the study. There were no significant differences between groups for mean percentage attendance at physical activity sessions (I/C group=24.1%, 95% CI, 15.4-32.9; C/I group=31.7%, 95% CI, 22.4-41.1, P=0.229).
                Children given active intervention followed by body composition monitoring alone reduced their BMI SDS, and fewer children were classified as grossly overweight by the end of the study. If these findings are true, there are important implications for the provision of services managing overweight in the community. Childhood obesity has become a nutritional problem in China since the 1990s.
                A family based behavioural treatment was developed and tested, to see if its use was feasible in China and to evaluate its impact on obese schoolchildren.
                In a single school in Beijing, 33 obese children were randomly assigned to a treatment group and 35 to a control group. The treatment group participated in a family based behavioural treatment programme for two years. Height and weight were measured every six months for all participants. Blood pressure, cholesterol, and triglyceride levels were measured at baseline and after two years of programme implementation.
                Body mass index (BMI, kg/m2) was significantly reduced in the treatment group (from 26.6 (1.7) to 24.0 (0.9), 95% CI 2.06 to 3.18) but not in the control group (from 26.1 (1.5) to 26.0 (1.6)). Total cholesterol decreased 5.5% and triglycerides 9.7% in the treatment group. There was a significant correlation between change in BMI and change in triglycerides. There were no significant changes in plasma lipids in the controls. Blood pressure values also decreased significantly in the treatment, but not the control group.
                A family based behavioural intervention was feasible to use in treating obesity in schoolchildren in Beijing, China. After two years of implementation, it successfully decreased the degree of obesity, reduced levels of blood pressure, and decreased serum lipids in treatment; there were no significant changes among control children. Moderate weight loss is recommended for overweight and obese patients with type 2 diabetes, and conjunctive use of weight loss medication has been advocated. The current study examined weight loss-dependent and -independent effects of the intestinal lipase inhibitor orlistat at 6 months of treatment, using behavioral intervention (Int) combined with randomized, double-blinded, placebo (P)-controlled treatment with orlistat (O).
                Metabolic control, insulin sensitivity (IS), regional fat distribution, and fat content in liver and muscle were measured in 39 volunteers with type 2 diabetes in whom all antidiabetic medication was withdrawn 1 month preceding randomization. Weight loss was equivalent in the Int+O and Int+P groups, respectively (-10.3 +/- 1.3 vs. -8.9 +/- 1.1%), and there were identical decreases in visceral adipose tissue (VAT), fat mass (FM), thigh adiposity, and hepatic steatosis.
                Weight loss resulted in substantial improvement (P < 0.001) in HbA(1c) (-1.6 +/- 0.3 vs. -1.0 +/- 0.4%; NS between groups). IS improved significantly more with orlistat (Delta2.2 +/- 0.4 vs. Delta1.2 +/- 0.4 mg. min(-1). kg(-1) fat-free mass [FFM]; P < 0.05), and plasma free fatty acid (FFA) levels were strongly correlated with IS (r = 0.56; P < 0.001). Orlistat caused greater reductions in fasting plasma FFA (Delta-154 +/- 22 vs. Delta-51 +/- 33 micro mol/l; P < 0.05), insulin-suppressed FFA (Delta-119 +/- 23 vs. Delta-87 +/- 34 micro mol/l; P < 0.05), and fasting plasma glucose (FPG; -62 +/- 9 vs. -32 +/- 8 mg/dl; P = 0.02). Changes in HbA(1c) were correlated with DeltaIS (r = -0.41; P < 0.01) but not with weight loss per se.
                At equivalent weight loss, conjunctive use of orlistat resulted in greater improvement in FFA levels and IS. We conducted a proof-of-concept, randomized, controlled trial to investigate the effects of a supervised exercise therapy intervention on psychopathologic outcomes in obese adolescents.
                The participant sample consisted of 81 adolescents (age: 11-16 years) who had been referred to a children's hospital for evaluation of obesity or who responded to a community advertisement. Participants were assigned randomly to exercise therapy, an equal-contact exercise placebo intervention, or usual care. Intervention participants attended 3 one-on-one sessions per week for 8 weeks and then completed a home program for another 6 weeks. Outcomes included self-perceptions (self-esteem), depression, affect, physical activity, aerobic fitness, and BMI.
                A total of 18 of 81 participants were categorized as morbidly obese (BMI SD score: > 3.5; adult equivalent BMI: > or = 40). At baseline, 30.3% of participants had a Children's Depression Inventory score of > or = 13, and 27% reported recent suicidal ideation. Repeated-measures mixed analysis of covariance (controlling for baseline scores) revealed significant changes in physical self-worth, associated measures of self-esteem, and physical activity over time, consistently favoring exercise therapy. There were no significant changes in BMI.
                Findings confirmed psychopathologic conditions as a serious health concern in obese and morbidly obese adolescents. Our study is the first randomized, controlled trial to demonstrate that a brief supervised exercise therapy intervention has the potential to improve psychopathologic outcomes significantly and to increase physical activity in obese adolescents, relative to usual care. We evaluated the effects of 12-month treatment with sibutramine 15 mg daily compared with placebo on health-related quality of life (HRQL) in obese type II diabetes patients. We examined the associations between the changes in HRQL and in weight, glycaemic control, and haemodynamic variables. We also explored the predictive value of HRQL and its changes early during treatment.
                A randomised clinical trial. The subjects were enrolled in a 2-week single-blind run-in period with a modestly hypocaloric diet (700 kcal daily deficit) and then randomised to receive either sibutramine 15 mg (n=114, 60% female) or placebo (n=122, 58% female) once daily with the hypocaloric diet for 12 months.
                Obese (mean BMI 36 kg/m(2) and age 54 y) type II diabetes patients untreated with antidiabetic medications.
                The main outcome measures included body weight and HRQL (the RAND 36-Item Health Survey 1.0).
                The mean weight loss was greater in the sibutramine group (-7.1 kg) than in the placebo group (-2.6 kg, P<0.001). The baseline HRQL was relatively high. There were no significant differences between the treatment groups in glycaemic control or in any of the RAND-36 scales during the study. The scores on physical functioning (PF) and health change (HC) since last year improved in both groups and this improvement was related to weight loss. When HRQL changes were examined in categories of weight loss, the scores on PF and HC increased with >/=5% weight loss, but the scores on vitality (V) and general health (GH) increased only after >/=15% weight loss. Decrease in HbA1c was associated with increases in the scores of PF, GH, V, mental health, and HC. In the sibutramine group, the increase in diastolic blood pressure was associated with the decrease in the scores of PF, physical role functioning, emotional role functioning (ERF), social functioning (SF), and bodily pain. High baseline scores on ERF and SF, and low scores on V predicted weight loss at 12 months. Also, increasing scores on PF and V during the first 3 months predicted weight loss at 12 months. The sum of four dichotomised HRQL variables (baseline ERF >/=75=1 and <75=0; baseline SF>/=80=1 and <80=0; 3-month change in PF>0=1 and </=0=0; 3-month change in V>0=1 and </=0=0) predicted weight loss: In the group with sum 0, the mean(s.d.) weight change at 12 months was 0.0(2.6)% and with sum 4 it was -9.0(8.1)% of baseline weight.
                Despite the superior weight loss, sibutramine 15 mg daily did not produce HRQL benefits over placebo when measured with the generic RAND-36 in obese type II diabetes patients. PF and HC since last year improved with >/=5% weight loss, but >/=15% weight loss was needed to achieve a cluster of HRQL improvements. The decrease in HbA1c was associated with many HRQL benefits. Poor baseline HRQL and the improvement observed in the first months of treatment may prove to be useful in predicting success in long-term weight loss. To assess the effect of orlistat on body weight and cardiovascular risk amongst obese patients at high coronary risk.
                After screening, patients entered a two-week single-blind placebo lead-in period, during which they followed a mildly hypocaloric diet, before being randomized to double-blind treatment with either orlistat 120 mg or placebo three times daily, in conjunction with dietary intervention for 1 years.
                The study was conducted at 33 primary care centres in Sweden.
                A total of 382 obese adults (body mass index 28-38 kg m-2) with type 2 diabetes, hypercholesterolaemia and/or hypertension were recruited, of whom 376 were randomized to orlistat (n = 190) or placebo (n = 186).
                Change in body weight, waist and hip circumferences, blood pressure, serum lipid profile, fasting glucose and HbA1c.
                After 1 years, mean weight loss was significantly greater with orlistat compared with placebo (5.9% vs. 4.6%; P < 0.05). Moreover, significantly more orlistat-treated patients than placebo recipients maintained weight loss of > or = 5% (54.2% vs. 40.9%; P < 0.001). Orlistat was also associated with significantly greater improvements than placebo in total serum cholesterol (- 3.3% vs. -0.5%; P < 0.05), LDL-cholesterol (- 7.0% vs. -1.1%; P < 0.05), fasting glucose (5.1% vs. -0.1%; P < 0.01) and HbA1c (- 2.7% vs. -0.5%; P < 0.05). Similar results were reported for the subgroup of patients with type 2 diabetes. Orlistat was well tolerated.
                Treatment with orlistat in conjunction with diet promotes significantly greater weight loss and cardiovascular risk factor reduction than diet alone amongst obese patients at high risk of future coronary events. To assess the efficacy and tolerability of orlistat (Xenical) in producing and maintaining weight loss over a 12-month period.
                Patients were randomized to double-blind treatment with either orlistat 120 mg or placebo three times daily, in conjunction with a low-energy diet, for 12 months.
                Five centres in the UK.
                228 obese adult patients with body mass index between 30 and 43 kg/m2 and mean weight 97 kg (range 74-144 kg).
                All patients were prescribed a low-energy diet, providing 30% of energy from fat, designed to produce an individually tailored energy deficit of approximately 600 kcal/day, for a run-in period of 4 weeks and then 12 months, plus orlistat 120 mg or placebo three times daily.
                Change in body weight (the primary efficacy parameter), waist circumference and adverse events were reviewed regularly, together with serum lipids, insulin, glucose and plasma levels of fat-soluble vitamins and beta carotene.
                Based on an intent-to-treat analysis, after 1 y of treatment patients receiving orlistat had lost an average of 8.5% of their initial body weight compared with 5.4% for placebo-treated patients; 35% of the orlistat group lost at least 5% of body weight compared with 21% of the placebo group (P < 0.05), and 28% and 17%, respectively (P = 0.04) lost at least 10% of body weight. Orlistat-treated patients showed significant decreases (P < 0.05) in serum levels of total cholesterol, low density lipoprotein cholesterol, and in the low density lipoprotein: high density lipoprotein ratio in comparison with placebo. Both groups had similar adverse-event profiles, except for gastrointestinal events, which were 26% more frequent in the orlistat group but were mostly mild and transient. To maintain normal plasma levels of fat-soluble vitamins, supplements of vitamins A, D and E were given to 1.8%, 8.0% and 3.6%, respectively, of orlistat-treated patients, compared with 0.9% of placebo-treated patients for each vitamin type. After 1 y, the decrease in vitamin E and beta carotene was significantly greater in orlistat-treated patients compared with those receiving placebo (P < 0.001). No significant change was found in the mean vitamin E:total cholesterol ratio in either group after 52 weeks.
                Orlistat, in conjunction with a low-energy diet, produced greater and more frequent significant weight loss than placebo during 1 y of treatment. One-third of orlistat-treated patients achieved clinically relevant weight loss (> or = 5% initial body weight). There was also an improvement in relevant serum lipid parameters. Fat-soluble vitamin supplements may be required during chronic therapy. Orlistat was well tolerated and offers a promising new approach to the long-term management of obesity. Obesity is common in persons with schizophrenia. Besides its adverse health effects, obesity reduces quality of life and contributes to the social stigma of schizophrenia.
                This 14-week, multicenter, open-label, rater-blinded, randomized study evaluated the effects of a group-based behavioral treatment (BT) for weight loss in overweight and obese stable patients with DSM-IV schizophrenia or schizoaffective disorder who had been switched from olanzapine to risperidone. Participants were randomly assigned to receive BT or usual clinical care (UC). BT included 20 sessions during which patients were taught to reduce caloric intake. In UC, patients were encouraged to lose weight but received no special advice about weight reduction. The primary outcome measure was change in body weight.
                Seventy-two patients were enrolled. The mean +/- SD weight loss at endpoint was significant in both groups (p < .05) and numerically greater in patients receiving BT than in those receiving UC (-2.0 +/- 3.79 and -1.1 +/- 3.11 kg, respectively). More patients in the BT group than in the UC group had lost > or = 5% of their body weight at endpoint (26.5% [9/34] and 10.8% [4/37], respectively; p = .082). A post hoc analysis of patients attending at least 1 BT session showed that significantly more patients in the BT than the UC group had lost > or = 5% of their body weight at endpoint (32.1% [9/28] vs. 10.8% [4/37], respectively, p = .038) and at week 14 (complete population; 40.9% [9/22] and 14.3% [4/28], respectively, p = .027).
                BT may be an effective method for weight reduction in patients with chronic psychotic illness. This randomized controlled trial tested the efficacy of an internet-based lifestyle behavior modification program for weight management in African-American girls.
                African-American girls were randomly assigned to an interactive behavioral internet program or an internet health education program, the control condition. The behavioral intervention included internet counseling and was highly interactive. The control intervention was a passive (non-interactive) educational program. Parents were also participants in the study. Participants in both treatment groups met in face-to-face sessions on four occasions over the first 12 weeks of a 6-month intervention.
                The study enrolled 57 African-American adolescent girls (ages 11 to 15 years) who were overweight or obese and had at least one biological parent who was obese [body mass index (BMI) >30 kg/m2]. Of the 57 participants, 50 (88%) completed the 6-month trial.
                Outcome data, including BMI, body weight, body composition, dietary intake, and weight loss behaviors were collected at baseline and 6-months later. A computer server tracked utilization of the websites. Participation in the program was measured by number of "hits" on the website.
                Compared to the control condition, adolescents in the behavioral treatment lost more body fat (group difference =1.6% body fat) and parents lost significantly more body weight (group difference =2.1 kg). Utilization of the behavioral website by adolescents and parents was associated with positive outcome. Dietary fat intake was lowered for adolescents and parents in the behavioral treatment group.
                An internet-based behavioral intervention was superior to internet-based health education and yielded decreased body fat for adolescent girls and decreased body weight for parents. Obese children (8-13 years old) and at least one of their parents participated in a behaviorally oriented treatment program. Participants in a standard treatment condition experienced a multicomponent intervention in which parents were given primary responsibility for following program prescriptions. An enhanced child involvement condition provided the same basic intervention but with greater emphasis on, and training in, child self-regulation. Children in both conditions achieved a significant reduction in percentage overweight and triceps skin-fold during the 6-month treatment period. Overall, the follow-up period of 3 years was characterized by increases above posttreatment levels. There was, however, some suggestion in the 3-year follow-up results and the long-term patterns over a 6 1/2-year period of the benefits of the enhanced child involvement approach. Findings are discussed in terms of suggestions for reconsideration of treatment goals, improved interventions, and refinements in the assessment of self-regulatory behavior. Olanzapine is the most commonly prescribed atypical antipsychotic medication in Australia. Research reports an average weight gain of between 4.5 and 7 kg in the 3 months following its commencement. Trying to minimize this weight gain in a population with an already high prevalence of obesity, mortality and morbidity is of clinical and social importance. This randomized controlled trial investigated the impact of individual nutrition education provided by a dietitian on weight gain in the 3 and 6 months following the commencement of olanzapine.
                Fifty-one individuals (29 females, 22 males) who had started on olanzapine in the previous 3 months (mean length of 27 days +/- 20) were recruited through Peninsula Health Psychiatric Services and were randomly assigned to either the intervention (n = 29) or the control group (n = 22). Individuals in the intervention group received six 1 hour nutrition education sessions over a 3-month period. Weight, waist circumference, body mass index (BMI) and qualitative measures of exercise levels, quality of life, health and body image were collected at baseline at 3 and 6 months.
                After 3 months, the control group had gained significantly more weight than the treatment group (6.0 kg vs 2.0 kg, p < or = 0.002). Weight gain of more than 7% of initial weight occurred in 64% of the control group compared to 13% of the treatment group. The control group's BMI increased significantly more than the treatment group's (2 kg/m(2)vs 0.7 kg/m(2), p < or = 0.03). The treatment group reported significantly greater improvements in moderate exercise levels, quality of life, health and body image compared to the controls. At 6 months, the control group continued to show significantly more weight gain since baseline than the treatment group (9.9 kg vs 2.0 kg, p < or = 0.013) and consequently had significantly greater increases in BMI (3.2 kg/m(2)vs 0.8 kg/m(2), p < or = 0.017).
                Individual nutritional intervention provided by a dietitian is highly successful at preventing olanzapine-induced weight gain. To determine the efficacy and tolerability of sibutramine hydrochloride in obese patients whose type 2 diabetes was poorly controlled on diet alone or with an oral antidiabetic agent.
                This study was a 24-week, double-blind, multicentre trial following a 5-week placebo run-in period. One hundred and seventy-five obese (body mass index (b.m.i.) > or =27 kg/m2) patients with poorly controlled type 2 diabetes mellitus were randomized either to sibutramine (n = 89; mean age 53.5 years; mean weight 99.3 kg) or placebo (n = 86; mean age 55 years; mean weight 98.2 kg) at 16 participating centres. To achieve moderate calorie restriction (deficit > or = 250-500 kcal/day), individual dietary counselling was accompanied by either placebo or sibutramine (initial dosage of 5 mg/day titrated up by 5 mg biweekly through week 6, and maintained at 20 mg through week 24). The main outcome measures included changes in weight, b.m.i., waist and hip circumference, glycaemic control, lipid profile, and quality of life, and evaluation of reported adverse events.
                Sixty-seven per cent of sibutramine patients and 71% of placebo patients completed the study. At week 24 when comparing those who completed the course, sibutramine compared with placebo patients showed significantly greater (p < 0.001) absolute (-4.3 vs. -0.4 kg) and percentage (-4.5% vs. -0.5%) weight loss. Weight loss > or =5% or 10% was achieved by 33% and 8% of sibutramine patients, respectively, but no placebo patients (p < 0.03 or better). Improvement in glycaemic control was correlated with weight loss (p < 0.001). In 5% and 10% weight-loss responders, mean treatment differences were -0.53% and -1.65% (p < or = 0.05), respectively, for HbA1c, and -1.4 mmol/l (p < or =0.05) and -3.8 (p < or =0.05) mmol/l for fasting plasma glucose. Sibutramine patients also showed improvements in fasting insulin, triglycerides, HDL cholesterol, and quality-of-life assessments. Overall, sibutramine was well tolerated compared with the placebo. Sibutramine treatment was associated with small mean increases in blood pressure (BP) and pulse, although an increase in BP was not seen in sibutramine-treated patients who lost > or = 5% of their weight.
                Sibutramine produced statistically and clinically significant weight loss when used in combination with recommendations for moderate caloric restriction. This weight loss was associated with improvements in metabolic control and quality of life, and sibutramine was generally well tolerated in obese patients with type 2 diabetes. To evaluate the effectiveness of an intervention to prevent excess weight gain, reduce time spent in screen behaviours, promote participation in and enjoyment of physical activity (PA), and improve fundamental movement skills among children.
                In 2002, 311 children (78% response; 49% boys), average age 10 years 8 months, were recruited from three government schools in low socioeconomic areas of Melbourne, Australia.
                Group-randomized controlled trial. Children were randomized by class to one of the four conditions: a behavioural modification group (BM; n=66); a fundamental movement skills group (FMS; n=74); a combined BM/FMS group (BM/FMS; n=93); and a control (usual curriculum) group (n=62). Data were collected at baseline, post intervention, 6- and 12-month follow-up periods.
                BMI data were available for 295 children at baseline and 268 at 12-month follow-up. After adjusting for food intake and PA, there was a significant intervention effect from baseline to post intervention on age- and sex-adjusted BMI in the BM/FMS group compared with controls (-1.88 kg m(-2), P<0.01), which was maintained at 6- and 12-month follow-up periods (-1.53 kg m(-2), P<0.05). Children in the BM/FMS group were less likely than controls to be overweight/obese between baseline and post intervention (adjusted odds ratio (AOR)=0.36, P<0.05); also maintained at 12-month follow-up (AOR=0.38, P<0.05). Compared with controls, FMS group children recorded higher levels and greater enjoyment of PA; and BM children recorded higher levels of PA and TV viewing across all four time points. Gender moderated the intervention effects for participation in and enjoyment of PA, and fundamental movement skills.
                This programme represents a promising approach to preventing excess weight gain and promoting participation in and enjoyment of PA. Examination of the mediators of this intervention and further tailoring of the programme to suit both genders is required. StEP TWO is a school- and family-based intervention consisting of extra lessons, healthy nutrition and physical education for overweight and obese children in primary schools, aimed at reducing body mass index by maintenance or reduction of weight, and improving motor abilities. We analysed differences in changes in anthropometric, cardiovascular and obesity parameters between children who underwent intervention, non-participants in intervention, and controls.
                Anthropometric data and waist circumference were recorded for 1678 children; body mass index and body mass index-standard deviation score were calculated. Blood pressure was measured after 5 minutes at rest. 121 overweight and obese children enrolled at 3 schools involved in programmes of intervention were invited to take part; 40 of them completed the programme from November 2003 to July 2004. Of these overweight children, 74 were invited, but did not take part. As controls, we enrolled 155 overweight and obese children from 4 other schools.
                After the programme, the children involved in intervention showed a lower increase in the body mass index (0.3 plus or minus 1.3 versus 0.7 plus or minus 1.2 kilograms per metre squared) and an approximately three times higher diminution of the body mass index-standard deviation score in comparison with their controls (-0.15 plus or minus 0.26 versus 0.05 plus or minus 0.27). Systolic blood pressure was significantly lowered by 9.5 plus or minus 19.6 millimetres of mercury in those involved in intervention, but increased in the control group by 0.5 plus or minus 16.5 millimetres of mercury. Among those invited but not participating, the increase of the body mass index (0.5 plus or minus 1.3 kilograms per metre squared) was less, and the reduction of the body mass index-standard deviation score (-0.09 plus or minus 0.31) and systolic blood pressure (-5.3 plus or minus 15.6 millimetres of mercury) was higher than in the control group. Overweight but not obese children seem to benefit from a screening examination alone.
                Early preventive measures in schools are necessary and effective for overweight and obese primary school children. The screening itself seems also to have a minor positive effect, especially for overweight children. Sustainability of the observed improvements over a longer period remains to be confirmed. To investigate the hypothesis that weight reduction with orlistat plus mild caloric restriction leads to better blood pressure control than diet alone in obese individuals with inadequately controlled hypertension. DESIGN This was a 1-year, prospective, randomized, double-blind, placebo-controlled, multicenter trial of orlistat plus diet versus placebo plus diet in obese hypertensives.
                Participants were randomized to receive either orlistat or placebo; all received a 600 kcal deficient diet with no more than 30% of calories from fat. Weight and blood pressure, lipid levels and fasting glucose and insulin levels were followed.
                Patients on orlistat experienced greater weight loss (-5.4 +/- 6.4 versus -2.7 +/- 6.4 kg, P< 0.001) and greater reduction in body mass index (-1.9 +/- 2.3 versus -0.9 +/- 2.2 kg/m2, P<0.001). Target weight loss, defined as > or= 5% body weight (BW), was obtained in more orlistat-treated patients than in the placebo group (46 versus 23%, P<0.001). Diastolic BP decreased more in orlistat-treated patients than in the placebo group (-11.4 +/- 8.3 versus -9.2 +/- 8.4 mmHg, P = 0.002). A greater percentage of orlistat-treated patients reached goal diastolic blood pressure (BP), defined as final diastolic BP< 90 mmHg or a reduction of at least 10 mmHg (67 versus 53%, P< 0.001). The orlistat-treated group had significantly greater reductions in total cholesterol ( P<0.001), low-density lipoprotein cholesterol (P = 0.001) and non-high-density lipoprotein cholesterol (P< 0.005) and target 30% cardiovascular risk reduction was obtained in more orlistat-treated patients (36.1 versus 24.0%, P< 0.04).
                A weight-loss program with orlistat is more effective than diet alone to lower blood pressure and results in greater cardiovascular risk reduction. Obesity has become the most common pediatric chronic disease in the modern era. Early prevention and treatment of childhood and adolescent obesity is mandated. Surprisingly, however, only a minor fraction of obese children participate in weight reduction interventions, and the longer-term effects of these weight-reduction interventions among children have not been elucidated.
                To examine prospectively the short- and long-term effects of a 3-month, combined dietary-behavioral-physical activity intervention on anthropometric measures, body composition, dietary and leisure-time habits, fitness, and lipid profiles among obese children.
                In this randomized prospective study, 24 obese subjects completed the 3-month intervention and were compared with 22 obese, age- and gender-matched, control subjects.
                At 3 months, there were significant differences in changes in body weight (-2.8 +/- 2.3 kg vs 1.2 +/- 2.2 kg), BMI (-1.7 +/- 1.1 kg/m2 vs -0.2 +/- 1.0 kg/m2), body fat percentage (from skinfold tests; -3.3 +/- 2.6% vs 1.4 +/- 4.7%), serum total cholesterol level (-24.6 +/- 15.1 mg/dL vs 0.8 +/- 18.7 mg/dL), low-density lipoprotein cholesterol level (-23.3 +/- 15.2 mg/dL vs -3.7 +/- 17.3 mg/dL), and fitness (215 +/- 107 seconds vs 50 +/- 116 seconds) in the intervention group versus the control group. After a 1-year follow-up period, there were significant differences between the intervention group (n = 20) and the control group (n = 20) in body weight (0.6 +/- 6.0 kg vs 5.3 +/- 2.7 kg), BMI (-1.7 +/- 2.3 kg/m2 vs 0.6 +/- 0.9 kg/m2), and body fat percentage. There was a significant increase in leisure-time physical activity among the intervention participants, compared with a decrease among the control subjects.
                Our data demonstrate the short- and longer-term beneficial effects of a combined dietary-behavioral-physical activity intervention among obese children. These results highlight the importance of multidisciplinary programs for the treatment of childhood obesity and emphasize their encouraging long-term effects.
While there is limited quality data to recommend one treatment program to be favoured over another, this review shows that combined behavioural lifestyle interventions compared to standard care or self-help can produce a significant and clinically meaningful reduction in overweight in children and adolescents. In obese adolescents, consideration should be given to the use of either orlistat or sibutramine, as an adjunct to lifestyle interventions, although this approach needs to be carefully weighed up against the potential for adverse effects. Furthermore, high quality research that considers psychosocial determinants for behaviour change, strategies to improve clinician-family interaction, and cost-effective programs for primary and community care is required.