title: A 6-month randomized controlled trial to test the efficacy of a lifestyle intervention for weight gain management in schizophrenia Twenty-five year mortality of a community cohort with schizophrenia. Effects of adjunctive treatment with aripiprazole on body weight and clinical efficacy in schizophrenia patients treated with clozapine: a randomized, double-blind, placebo-controlled trial. Placebo-Controlled Pilot Study of Ramelteon for Adiposity and Lipids in Patients With Schizophrenia Inequalities in physical comorbidity: a longitudinal comparative cohort study of people with severe mental illness in the UK A cognitive/behavioral group intervention for weight loss in patients treated with atypical antipsychotics Development of a methodological PubMed search filter for finding studies on measurement properties of measurement instruments Patient-important outcomes in registered diabetes trials. A behavioral weight-loss intervention in persons with serious mental illness. A lifestyle intervention for older schizophrenia patients with diabetes mellitus: A randomized controlled trial Individuals with diabetes preferred that future trials use patient-important outcomes and provide pragmatic inferences.
abstract: Background Patients with schizophrenia have lower longevity than the general population as a consequence of a combination of risk factors connected to the disease , lifestyle and the use of medications , which are related to weight gain . Methods A multicentric , r and omized , controlled-trial was conducted to test the efficacy of a 12-week group Lifestyle Wellness Program ( LWP ) . The program consists of a one-hour weekly session to discuss topics like dietary choices , lifestyle , physical activity and self-esteem with patients and their relatives . Patients were r and omized into two groups : st and ard care ( SC ) and st and ard care plus intervention ( LWP ) . Primary outcome was defined as the weight and body mass index ( BMI ) . Results 160 patients participated in the study ( 81 in the intervention group and 79 in the SC group ) . On an intent to treat analysis , after three months the patients in the intervention group presented a decrease of 0.48 kg ( CI 95 % -0.65 to 1.13 ) while the st and ard care group showed an increase of 0.48 kg ( CI 95 % 0.13 to 0.83 ; p=0.055 ) . At six-month follow-up , there was a significant weight decrease of −1.15 kg , ( CI 95 % -2.11 to 0.19 ) in the intervention group compared to a weight increase in the st and ard care group ( + 0.5 kg , CI 95 % -0.42–1.42 , p=0.017 ) . Conclusion In conclusion , this was a multicentric r and omized clinical trial with a lifestyle intervention for individuals with schizophrenia , where the intervention group maintained weight and presented a tendency to decrease weight after 6 months . It is reasonable to suppose that lifestyle interventions may be important long-term strategies to avoid the tendency of these individuals to increase weight . Clinical trials.gov BACKGROUND People with schizophrenia have significantly raised mortality but we do not know how these mortality patterns in the UK have changed since the 1990s . AIMS To measure the 25-year mortality of people with schizophrenia with particular focus on changes over time . METHOD Prospect i ve record linkage study of the mortality of a community cohort of 370 people with schizophrenia . RESULTS The cohort had an all-cause st and ardised mortality ratio of 289 ( 95 % CI 247 - 337 ) . Most deaths were from the common causes seen in the general population . Unnatural deaths were concentrated in the first 5 years of follow-up . There was an indication that cardiovascular mortality may have increased relative to the general population ( P = 0.053 ) over the course of the study . CONCLUSIONS People with schizophrenia have a mortality risk that is two to three times that of the general population . Most of the extra deaths are from natural causes . The apparent increase in cardiovascular mortality relative to the general population should be of concern to anyone with an interest in mental health Clozapine is associated with significant weight gain and metabolic disturbances .  This multicentre , r and omized study comprised a double-blind , placebo-controlled treatment phase of 16 wk , and an open-label extension phase of 12 wk . Out patients who met DSM-IV-TR criteria for schizophrenia , who were not optimally controlled while on stable dosage of clozapine for > or =3 months and had experienced weight gain of > or = 2.5 kg while taking clozapine , were r and omized ( n=207 ) to aripiprazole at 5 -  15  mg/d or placebo , in addition to a stable dose of clozapine . The primary endpoint was mean change from baseline in body weight at week 16 ( last observation carried forward ) . Secondary endpoints included clinical efficacy , body mass index ( BMI ) and waist circumference . A statistically significant difference in weight loss was reported for aripiprazole vs. placebo ( -2.53 kg vs. -0.38 kg , respectively , difference=-2.15 kg , p<0.001 ) . Aripiprazole-treated patients also showed BMI ( median reduction 0.8 kg/m(2 ) ) and waist circumference reduction ( median reduction 2.0 cm ) vs. placebo ( no change in either parameter , p<0.001 and p=0.001 , respectively ) . Aripiprazole-treated patients had significantly greater reductions in total and low-density lipoprotein ( LDL ) cholesterol . There were no significant differences in Positive and Negative Syndrome Scale total score changes between groups but Clinical Global Impression Improvement and Investigator 's Assessment Question naire scores favoured aripiprazole over placebo .  Safety and tolerability were generally comparable between groups . Combining aripiprazole and clozapine result ed in significant weight , BMI and fasting cholesterol benefits to patients suboptimally treated with clozapine . Improvements may reduce metabolic risk factors associated with clozapine treatment Objective : Few interventions have been successful to prevent or reverse the medical complications associated with antipsychotic agents in the schizophrenia population . In particular , no single agent can correct multiple metabolic abnormalities such as insulin resistance , hyperlipidemia , inflammation , obesity , and fat distribution . We now report a r and omized placebo-controlled pilot study to examine the effects of ramelteon on obesity and metabolic disturbances among subjects with schizophrenia . Methods : A double-blind , placebo-controlled , 8-week pilot trial was conducted , adding ramelteon 8 mg/d to stable out patients with schizophrenia .  Vital signs and anthropometric measurements , including height , weight , waist circumference , and body fat were assessed , and laboratory assays were tracked to monitor changes in metabolic markers . Results : Twenty-five subjects were r and omly assigned to treatment with study drug or placebo , and 20 subjects were included in the final analysis .  Ramelteon did not improve anthropometric measurements , glucose metabolism , and inflammatory markers . There was , however , a significant decrease in total cholesterol and ratio of cholesterol to high-density lipoprotein in the ramelteon group . Although the st and ard anthropometric measures did not show significant change , the dual-energy x-ray absorptiometry scan showed a trend toward reduction in fat in the abdominal and trunk areas with a moderate effect size . Conclusions : Although ramelteon decreased cholesterol , treatment may have to be longer than 8 weeks and with a higher dose for maximal effect of ramelteon for body fat and lipid changes . Future studies are needed for patients with schizophrenia with a larger sample size to fully underst and ramelteon 's effects on abdominal adiposity and lipids Objectives Little is known about the prevalence of comorbidity rates in people with severe mental illness ( SMI ) in UK primary care . We calculated the prevalence of SMI by UK country , English region and deprivation quintile , antipsychotic and antidepressant medication prescription rates for people with SMI , and prevalence rates of common comorbidities in people with SMI compared with people without SMI . Design Retrospective cohort study from 2000 to 2012 . Setting 627 general practice s contributing to the Clinical Practice Research Data link , a UK primary care data base . Participants Each identified case ( 346 551 ) was matched for age , sex and general practice with 5 r and omly selected control cases ( 1 732 755 ) with no diagnosis of SMI in each yearly time point . Outcome measures Prevalence rates were calculated for 16 conditions . Results SMI rates were highest in Scotl and and in more deprived areas . Rates increased in Engl and , Wales and Northern Irel and over time , with the largest increase in Northern Irel and ( 0.48 % in 2000/2001 to 0.69 % in 2011/2012 ) . Annual prevalence rates of all conditions were higher in people with SMI compared with those without SMI . The discrepancy between the prevalence of those with and without SMI increased over time for most conditions . A greater increase in the mean number of additional conditions was observed in the SMI population over the study period ( 0.6 in 2000/2001 to 1.0 in 2011/2012 ) compared with those without SMI ( 0.5 in 2000/2001 to 0.6 in 2011/2012 ) . For both groups , most conditions were more prevalent in more deprived areas , whereas for the SMI group conditions such as hypothyroidism , chronic kidney disease and cancer were more prevalent in more affluent areas . Conclusions Our findings highlight the health inequalities faced by people with SMI . The provision of appropriate timely health prevention , promotion and monitoring activities to reduce these health inequalities are needed , especially in deprived areas 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 l and mark multi-center r and omized-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 Objectives For the measurement of  patient-reported outcomes , such as ( health-related ) quality of life , often many measurement instruments exist that intend to measure the same construct . To facilitate instrument selection , our aim was to develop a highly sensitive search filter for finding studies on measurement properties of measurement instruments in PubMed and a more precise search filter that needs less abstract s to be screened , but at a higher risk of missing relevant studies . Methods A r and om sample of 10,000 PubMed records ( 01 - 01 - 1990 to 31 - 12 - 2006 ) was used as a gold st and ard . Studies on measurement properties were identified using an exclusion filter and h and search ing . Search terms were selected from the relevant records in the gold st and ard as well as from 100 systematic review s of measurement properties and combined based on sensitivity and precision . The performance of the filters was tested in the gold st and ard as well as in two validation sets , by calculating sensitivity , precision , specificity , and number needed to read . Results We identified 116 studies on measurement properties in the gold st and ard . The sensitive search filter was able to retrieve 113 of these 116 studies ( sensitivity 97.4 % , precision 4.4 % ) . The precise search filter had a sensitivity of 93.1 % and a precision of 9.4 % . Both filters performed very well in the validation sets . Conclusion The use of these search filters will contribute to evidence -based selection of measurement instruments in all medical fields CONTEXT Concerns about the safety and efficacy of diabetes interventions persist , in part because r and omized clinical trials ( RCTs ) have not measured their effect on patient-important outcomes , ie , death and quality of life ( morbidity , pain , function ) . OBJECTIVE To systematic ally determine the extent to which ongoing and future RCTs in diabetes will ascertain patient-important outcomes . DATA SOURCES On November 10 , 2007 , we search ed primary RCT registries Clinical Trials.gov ( http://www . clinical trials.gov ) , International St and ard R and omized Controlled Trial Number Register ( http://is rct n.org ) , and Australian New Zeal and Clinical Trials Registry ( http://www.anzctr.org.au ) . STUDY SELECTION We identified phase 2 through 4 RCTs  enrolling patients with diabetes . Of 2019 RCTs , 1054 proved eligible . We r and omly sample d 50 % of the eligible RCTs ( 527 of 1054 ) and selected 436 registered since registration became m and atory ( 2004 ) . DATA EXTRACTION Pairs of review ers working independently collected study characteristics and determined the outcomes measured and their type ( physiological outcomes , surrogate outcomes thought to reflect an increased risk for patient-important outcomes , and patient-important outcomes ) . RESULTS Of the 436 registered RCTs included in this analysis , 24 ( 6 % ) had not started enrollment , 109 ( 25 % ) were actively enrolling , and 303 ( 69 % ) had completed enrollment . Primary outcomes were patient-important outcomes in only 78 of 436 RCTs ( 18 % ; 95 % confidence interval [ CI ] , 14%-22 % ) , physiological and laboratory outcomes in 69 of 436 ( 16 % ; 95 % CI , 13%-20 % ) , and surrogate outcomes in 268 of 436 ( 61 % ; 95 % CI , 57%-66 % ) . Patient-important outcomes were reported as primary or secondary outcomes in 201 of 436 ( 46 % ; 95 % CI , 41%-51 % ) . In multivariate analysis , large trials ( odds ratio [ OR ] , 1.10 ; 95 % CI , 1.02 - 1.19 for every additional 100 patients ) and trials of longer duration ( OR , 1.03 ; 95 % CI , 1.01 - 1.06 for every additional 30 days ) were more likely while parallel design RCTs ( OR , 0.15 ; 95 % CI , 0.05 - 0.44 ) and type 2 diabetes trials ( OR , 0.23 ; 95 % CI , 0.09 - 0.61 ) were less likely to assess patient-important outcomes as a primary outcome . CONCLUSION In this sample of registered ongoing RCTs in diabetes , only 18 % included patient-important outcomes as primary outcomes BACKGROUND Overweight and obesity are epidemic among persons with serious mental illness , yet weight-loss trials systematic ally exclude this vulnerable population . Lifestyle interventions require adaptation in this group because psychiatric symptoms and cognitive impairment are highly prevalent . Our objective was to determine the effectiveness of an 18-month tailored behavioral weight-loss intervention in adults with serious mental illness . METHODS We recruited overweight or obese adults from 10 community psychiatric rehabilitation outpatient programs and r and omly assigned them to an intervention or a control group . Participants in the intervention group received tailored group and individual weight-management sessions and group exercise sessions .  Weight change was assessed at 6 , 12 , and 18 months . RESULTS Of 291 participants who underwent r and omization , 58.1 % had schizophrenia or a schizoaffective disorder , 22.0 % had bipolar disorder , and 12.0 % had major depression . At baseline , the mean body-mass index ( the weight in kilograms divided by the square of the height in meters ) was 36.3 , and the mean weight was 102.7 kg ( 225.9 lb ) . Data on weight at 18 months were obtained from 279 participants . Weight loss in the intervention group increased progressively over the 18-month study period and differed significantly from the control group at each follow-up visit . At 18 months , the mean between-group difference in weight ( change in intervention group minus change in control group ) was -3.2 kg ( -7.0 lb , P=0.002 ) ; 37.8 % of the participants in the intervention group lost 5 % or more of their initial weight , as compared with 22.7 % of those in the control group ( P=0.009 ) . There were no significant between-group differences in adverse events . CONCLUSIONS A  behavioral weight-loss intervention significantly reduced weight over a period of 18 months in overweight and obese adults with serious mental illness . Given the epidemic of obesity and weight-related disease among persons with serious mental illness , our findings support implementation of targeted behavioral weight-loss interventions in this high-risk population . ( Funded by the National Institute of Mental Health ; ACHIEVE Clinical Trials.gov number , NCT00902694 . ) PURPOSE We tested the feasibility and preliminary efficacy of a lifestyle intervention for middle-aged and older patients with schizophrenia and type-2 diabetes mellitus , using a r and omized pre-test , post-test control group design . METHOD Individuals with a diagnosis of schizophrenia or schizoaffective disorder over the age of 40 were r and omly assigned to 24-week Diabetes Awareness and Rehabilitation Training ( DART ; n=32 ) groups or Usual Care plus Information ( UCI ; n=32 ) comparison groups .  Participants were recruited from board- and -care facilities and day treatment programs . Fifty-seven patients completed baseline and 6-month assessment s consisting of an interview , measures of body mass index , blood pressure , fasting blood chemistry , and accelerometry . A mixed-model analysis of variance was used to analyze the data . RESULTS A significant group x time interaction was found for body weight , with patients in the DART group losing a mean of 5 lb and those in the UCI gaining a mean 6 lb . Significant group x time interactions were also found for triglycerides , diabetes knowledge , diabetes self-efficacy , and self-reported physical activity , but not for fasting plasma glucose or glycosylated hemoglobin . CONCLUSIONS Group-based lifestyle interventions are feasible and produce positive health changes in middle-aged and older patients with schizophrenia and diabetes mellitus OBJECTIVE We sought to examine patients ' preferences regarding the design of diabetes trials . Specifically , do patients prefer trials to focus on patient-important outcomes ( vs. surrogate outcomes ) and provide practical/pragmatic answers ( vs. mechanistic/explanatory answers ) ? STUDY DESIGN AND SETTING We mailed a question naire to a stratified r and om sample of 4,796 patients with diabetes receiving care from 371 primary care clinicians in the US Midwest . Medical record review provided data on hemoglobin A1c ( HbA1c ) . Descriptive statistics , logistic regression , and multiple regression techniques were used for analysis . RESULTS We received completed surveys from 2,036 patients ( response rate of 42.5 % ) . On average , respondents were 65 years old , had 11 years of diabetes , and had excellent glycemic control ( HbA1c=7 % ) . Most patients ( > 75 % ) chose patient-important outcomes rather than HbA1c as their first choice for a trial primary outcome and preferred a practical trial design . Patients with poor glycemic control ( HbA1c>8.0 % ) were more likely to prefer HbA1c as a primary end point ( odds ratio : 1.5 ; 95 % confidence interval : 1.1 , 2.1 ) . CONCLUSION Individuals with diabetes report a strong preference for practical trials measuring the effect of treatments on patient-important outcomes . To our knowledge , this is the first report of patients endorsing key elements of the comparative effectiveness agenda
target: Discussion The proposed core outcome set will provide clear guidance about what outcomes should be measured , as a minimum , in trials of interventions for people with coexisting type-2 diabetes and SMI , and improve future synthesis of trial evidence in this area .
background: Background People with diabetes and comorbid severe mental illness ( SMI ) form a growing population at risk of increased mortality and morbidity compared to those with diabetes or SMI alone .
  There is increasing interest in interventions that target diabetes in SMI in order to help to improve physical health and reduce the associated health inequalities .
  However , there is a lack of consensus about which outcomes are important for this comorbid population , with trials differing in their focus on physical and mental health .
  A core outcome set , which includes outcomes across both conditions that are relevant to patients and other key stakeholders , is needed .