A cluster randomised trial to evaluate a nutrition training programme. Physiologic effects of oral supplemental feeding in malnourished patients with chronic obstructive pulmonary disease. A randomized control study. Three month intervention with protein and energy rich supplements improve muscle function and quality of life in malnourished patients with non-neoplastic gastrointestinal disease--a randomized controlled trial. Multicentre, cluster-randomized clinical trial of algorithms for critical-care enteral and parenteral therapy (ACCEPT). Using dietetic assistants to improve the outcome of hip fracture: a randomised controlled trial of nutritional support in an acute trauma ward. Protein energy supplements in unwell elderly patients--a randomized controlled trial. Nutrition support using the American Dietetic Association medical nutrition therapy protocol for radiation oncology patients improves dietary intake compared with standard practice. Comparison of the effects of two early intervention strategies on the health outcomes of malnourished hemodialysis patients. Dietary counseling improves patient outcomes: a prospective, randomized, controlled trial in colorectal cancer patients undergoing radiotherapy. Perioperative nutritional support: a randomised clinical trial. Cost-effectiveness of an interdisciplinary intervention in geriatric inpatients to prevent malnutrition. Effect of training and a structured office practice on physician-delivered nutrition counseling: the Worcester-Area Trial for Counseling in Hyperlipidemia (WATCH). Protein-energy oral supplementation in malnourished nursing-home residents. A controlled trial. Benefits of nutritional supplementation in free-living, frail, undernourished elderly people: a prospective randomized community trial. A randomized, controlled, a single-blind trial of nutritional supplementation after acute stroke. Randomized controlled trial of nutritional counseling on body composition and dietary intake in severe CKD. Antenatal peer support workers and initiation of breast feeding: cluster randomised controlled trial. Effect of nursing interventions on nutritional and performance status in cancer patients. Oral protein energy supplements for children with cystic fibrosis: CALICO multicentre randomised controlled trial.
The need for training to equip primary care staff with the knowledge and skills to provide dietary advice to the public has been acknowledged. Little is known about the effectiveness of such training at improving the dietary counselling skills of multidisciplinary practice teams.
                To evaluate the effectiveness of a nutrition training programme, delivered to primary care teams by a dietitian.
                A paired-cluster randomised trial.
                Twelve general practices in Sunderland, in the United Kingdom.
                A nutrition training programme, aimed at improving the quality of dietary consultations, was developed and delivered to six primary care teams by a dietitian. Main outcome measures were patients' recall of seven key consulting behaviours. Data were collected from patients in intervention and control practices, pre- and post-intervention. Change in knowledge and attitude of practitioners was also measured.
                All 12 practices completed the trial. Data were collected from 251 patients pre-intervention and 228 patients post-intervention. Of the seven consulting behaviours targeted in the training, only the proportion of consultations where written information (diet sheets) was provided to patients was significantly higher (13% higher, 95% confidence interval [CI = 4 to 21, P = 0.004) in the intervention practices post-training. Some evidence of improved practitioner knowledge and attitude was detected.
                This evaluation of a nutrition training intervention detected only a limited impact on the behaviour, knowledge, and attitudes of primary care practitioners in dietary consultations. The association between severe nutritional depletion and chronic obstructive pulmonary disease (COPD) has long been recognized. A potential therapeutic benefit to nutritional support was previously suggested by us in a pilot investigation. Subsequent studies have reported conflicting results regarding the role of nutritional therapy in this clinical population. We report a randomized controlled study of nutritional therapy in underweight patients with COPD that combines an initial inpatient investigation (controlled nutritional support) with a prolonged outpatient follow-up interval. Provision of adequate calorie and protein support, adjusted to metabolic requirements, resulted in weight gain (intervention = +2.4 kg versus control -0.5 kg), improved handgrip strength (intervention = +5.5 kg-force versus control -6.0 kg-force), expiratory muscle strength (intervention = +14.9 cm H2O versus control -9.2 cm H2O), and walking distance (intervention = +429 feet versus control -1.0 foot). Inspiratory muscle strength was also improved (intervention = +11.4 cm H2O versus control +4.8 cm H2O) although this did not quite reach statistical significance. We conclude that provision of adequate nutrient supply under controlled conditions results in significant clinical improvements in the COPD patient population. However, the intervention is costly, time-intensive, and of limited therapeutic magnitude. More detailed work of alternative outpatient strategies combined with additional rehabilitative measures is indicated to delineate the full therapeutic potential of nutritional support for this clinical population. Malnutrition is a common problem in patients with digestive disease and is associated with impaired outcome.
                We investigated the effect of a three-month post-hospital nutritional intervention with high protein and energy supplements on body composition, muscle function and quality of life (QoL) in malnourished GI patients.
                Eighty malnourished patients with benign digestive disease were randomized to receive either oral nutritional supplements (ONS) for three months in addition to dietary counselling (DC) (ONS patients) or only dietary counselling (DC patients).
                Nutritional status was determined with the subjective global assessment, body composition by bioelectrical impedance and anthropometry, muscle function with hand-grip strength and peak flow. QoL was assessed by the 36-item short-form questionnaire.
                Age, body cell mass (BCM), muscle function, gender distribution and QoL did not differ between ONS patients (n=38) and DC patients (n=42) at baseline. Body weight and BCM improved significantly in both groups after three months. However, hand-grip strength (26.1+/-11.3-31.5+/-10.1 kg, p<0.0001) and peak flow (329.2+/-124.0-388.9+/-108.4 l /min, p=0.004) improved only in the ONS patients and remained unchanged in the DC patients. Similarly, all eight scales of the QoL improved in the ONS patients compared with merely three in the DC patients. DC patients experienced significantly more readmissions (n=20) than ONS patients (n=10) during the study period (p=0.041).
                A three month intervention with high protein oral supplements improves outcome in malnourished patients with digestive disease in terms of functional status, QoL and rehospitalization. The provision of nutritional support for patients in intensive care units (ICUs) varies widely both within and between institutions. We tested the hypothesis that evidence-based algorithms to improve nutritional support in the ICU would improve patient outcomes.
                A cluster-randomized controlled trial was performed in the ICUs of 11 community and 3 teaching hospitals between October 1997 and September 1998. Hospital ICUs were stratified by hospital type and randomized to the intervention or control arm. Patients at least 16 years of age with an expected ICU stay of at least 48 hours were enrolled in the study (n = 499). Evidence-based recommendations were introduced in the 7 intervention hospitals by means of in-service education sessions, reminders (local dietitian, posters) and academic detailing that stressed early institution of nutritional support, preferably enteral.
                Two hospitals crossed over and were excluded from the primary analysis. Compared with the patients in the control hospitals (n = 214), the patients in the intervention hospitals (n = 248) received significantly more days of enteral nutrition (6.7 v. 5.4 per 10 patient-days; p = 0.042), had a significantly shorter mean stay in hospital (25 v. 35 days; p = 0.003) and showed a trend toward reduced mortality (27% v. 37%; p = 0.058). The mean stay in the ICU did not differ between the control and intervention groups (10.9 v. 11.8 days; p = 0.7).
                Implementation of evidence-based recommendations improved the provision of nutritional support and was associated with improved clinical outcomes. To examine how improved attention to nutritional status and dietary intake, achieved through the employment of dietetic assistants (DAs), will affect postoperative clinical outcome among elderly women with hip fracture.
                Open prospective randomised controlled trial, comparing conventional nursing care with the additional nutritional support provided by DA.
                Thirty-eight bedded acute trauma ward in a teaching hospital.
                All but 11 of 344 consecutive admissions with acute nonpathological hip fracture were approached. Three hundred and eighteen (93%) agreed to inclusion. Sixteen were ineligible as they were immediately transferred to another acute ward, were managed conservatively or died preoperatively.
                Postoperative mortality in the acute trauma unit.
                Postoperative mortality at 4 months after fracture, length of stay, energy intake and nutritional status.
                DA-supported participants were less likely to die in the acute ward (4.1 versus 10.1%, P = 0.048). This effect was still apparent at 4 month follow-up (13.1 versus 22.9%, P = 0.036). DA-supported subjects had significantly better mean daily energy intake (1,105 kcal versus 756 kcal/24 h, 95% CI 259-440 kcal/24 h, P<0.001), significantly smaller reduction in mid-arm circumference during their inpatient stay (0.39 cm, P = 0.002) and nonsignificantly favourable results for other anthropometric and laboratory measurements.
                Dietetic or nutrition assistants are being introduced in units across the UK. This, the largest ever study of nutritional support after hip fracture, shows that their employment significantly reduced patients' risk of dying in the acute trauma unit; an effect that persisted at 4 month follow-up. To determine whether oral protein energy supplements, prescribed during hospitalization to elderly medical admissions, affect nutritional status and if baseline nutritional state influences this status. We also considered the effects on mortality, length of hospital stay, functional recovery, and institutionalization.
                A prospective randomized controlled trial with no placebo. Consenting patients were stratified in 3 nutritional categories, and patients from each stratum were randomized into treatment or control. Observers were blinded to randomization. The participants were emergency admissions from home to a Medicine for the Elderly Unit in a Scottish hospital. The inclusion criteria were as follows: no known malignancy, the ability to swallow, and nonobesity (BMI < 75th percentile). The intervention was a prescription of 120 mL sip feed, 3 times daily (540 kcal, 22.5 g protein per day) throughout hospitalization, using the medicine prescription chart. The trial was powered to detect change in mean percentage weight. The following outcomes were also considered: anthropometry; mortality, length of hospital stay, functional recovery, and rates of institutionalization.
                Included in the trial were 381 patients. Nutritional supplementation was associated with significantly better energy intake (p = .001) and weight gain (p = .003) pooled across all nutritional categories. In the most poorly nourished patients, the intervention was associated with reduced mortality (5/34 versus 14/40, p < .05) and more patients improved functionally (17/25 versus 11/28, p < .04). Overall mortality results were 21/186 versus 33/195, odds ratio (OR) 0.62, 95% confidence interval (CI) 0.35, 1.13.
                Prescribing sip feed supplements in the medicine prescription chart during hospital stay reduces weight loss. Our data also support other evidence for a reduction in mortality noted in elderly patients on nutritional supplementation. There were suggestions of other clinical benefits. A randomized controlled trial previously conducted in radiation oncology patients demonstrated that nutrition intervention had a beneficial impact on body weight, nutritional status, and quality of life compared with standard practice, but it did not report on dietary intake data.
                To determine the impact of nutrition intervention compared with standard practice on dietary intake in outpatients receiving radiotherapy.
                Prospective, randomized, controlled trial.
                Sixty consecutive radiation oncology outpatients (51 men and nine women; age 61.9+/-14 years [mean+/-standard deviation]).
                Australian private radiotherapy facility.
                Patients were randomly assigned to receive either nutrition intervention (n=29) (nutrition counseling following the American Dietetic Association [ADA] medical nutrition therapy [MNT] protocol for radiation oncology) or standard practice (n=31) (general nutrition talk and booklet).
                Dietary intake (protein, energy, fiber) assessed at baseline and at 4, 8, and 12 weeks after starting radiotherapy.
                Repeated-measures analysis of variance done on an intention to treat basis.
                The nutrition intervention group had a higher mean total energy (P=0.029) and protein intake (P<0.001) compared with the standard practice group. Mean intake per kilogram of body weight for the nutrition intervention group ranged from 28 to 31 kcal/kg/day compared with 25 to 29 kcal/kg/day for the standard practice group (P=0.022). The nutrition intervention group had a higher mean protein intake (1.1 to 1.3 g/kg/day) compared with the standard practice group (1.0 to 1.1 g/kg/day) (P=0.001). Although the change in fiber intake between the groups was not significant, there was a trend in the anticipated direction (P=0.083).
                Intensive nutrition intervention following the ADA MNT protocol results in improved dietary intake compared with standard practice and seems to beneficially impact nutrition-related outcomes previously observed in oncology outpatients receiving radiotherapy. The ADA MNT protocol for radiation oncology is a useful guide to the level of nutrition support required. To determine the efficacy and cost-effectiveness of providing oral supplementation early in the course of malnutrition for hemodialysis (HD) patients.
                The study design consisted of 3 groups: an experimental group, a control group of patients with mild hypoalbuminemia (HA) (serum albumin [SA] = 3.5 to 3.7 g/dL), and a comparison group of patients with moderate to severe HA (SA = 2.5 to 3.4 g/dL).
                Ten outpatient hemodialysis centers in southeast lower Michigan.
                Treatment and control groups consisted of 32 HD patients with mild HA. Fourteen HD patients with moderate to severe HA comprised the comparison group.
                The experimental group received diet counseling and oral supplementation, and the control group received diet counseling only. The comparison group received physician-prescribed oral supplements and dietary counseling to permit comparison of the experimental treatment with current supplementation practices.
                Differences between groups in the number of patients reaching nutritional repletion, change in SA levels at the end of the study, and follow-up periods, were tested using chi-square analysis. Analysis of variance was used to compare group differences in treatment duration to repletion and number of hospitalization days.
                During the study period, significantly more patients reached nutritional repletion in the experimental group and control group (50% and 57%, respectively) than in the comparison group (7%). Overall, repletion occurred more quickly in the experimental group (3.2 +/- 1.7 months) than in the control group (3.5 +/- 1.2 months), with a larger number of patients in the experimental group repleted by month 2 of the study phase. During follow-up, patients in the experimental group were far more likely to maintain nutritional repletion or continue to improve (61%) than patients in the control group (14%). Although too few patients were hospitalized to show statistical significance, there was a trend toward greater numbers of hospital days in more malnourished patients (208 days for the comparison group), followed by those with mild HA who did not receive oral supplements (107 days), and the experimental group (71 days).
                Although the sample size for this study was too small for the results to be conclusive, it appears that use of nutritional supplements early in the course of malnutrition may provide benefits such as, attaining nutritional repletion more quickly, which results in less product usage. It is also more likely that good nutritional status will be maintained after supplementation is discontinued.
                Copyright 2001 by the National Kidney Foundation, Inc. To investigate the impact of dietary counseling or nutritional supplements on outcomes in cancer patients: nutritional, morbidity, and quality of life (QoL) during and 3 months after radiotherapy.
                A total of 111 colorectal cancer outpatients referred for radiotherapy, stratified by staging, were randomly assigned: group 1 (G1; n = 37), dietary counseling (regular foods); group 2 (G2; n = 37), protein supplements; and group 3 (G3; n = 37), ad libitum intake. Nutritional intake (diet history), status (Ottery's Subjective Global Assessment), and QoL (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0) were evaluated at baseline, at the end, and 3 months after radiotherapy.
                At radiotherapy completion, energy intake increased in G1/G2 (P < or = .04), G1 more than G2 (P = .001), and decreased in G3 (P < .01). Protein intake increased in G1/G2 (P < or = .007), G1 less than G2 (not significant), and decreased in G3 (P < .01). At 3 months, G1 maintained nutritional intake and G2/G3 returned to baseline. After radiotherapy and at 3 months, rates of anorexia, nausea, vomiting, and diarrhea were higher in G3 (P < .05). At radiotherapy completion, in G1 all QoL function scores improved proportionally to adequate intake or nutritional status (P < .05); whereas in G2 only three of six function scores improved proportionally to protein intake (P = .04), and in G3 all scores worsened (P < .05). At 3 months, G1 patients maintained/improved function, symptoms, and single-item scores (P < .02); in G2, only few function and symptom scales improved (P < .05); in G3, QoL remained as poor as after radiotherapy. In G1/G2, respectively, improvement/deterioration of QoL correlated with better or poorer intake or nutritional status (P < .003).
                During radiotherapy, both interventions positively influenced outcomes; dietary counseling was of similar or higher benefit, whereas even 3 months after RT, it was the only method to sustain a significant impact on patient outcomes. Ever since methods of artificial nutritional support became available, attempts have been made using this form of treatment to reduce mortality and morbidity in surgical patients. Many trials have addressed this question, but very few have given a meaningful answer because of conceptual and methodological flaws. We therefore undertook a prospective randomised trial investigating the effects of at least 10 days pre-operative total parenteral nutrition (TPN) (n = 51) or total enteral nutrition (TEN) (n = 50) providing 150% basal energy expenditure (BEE) non-protein energy, to reduce major postoperative complications and mortality in a homogeneous patient group with signs of depletion. 50 patients served as a depleted control group (D) and 49 patients served as a non-depleted reference group (ND) and were operated upon without delay. Depleted control patients suffered significantly more septic complications than did patients in the non-depleted reference group (p < 0.05). There was no significant difference, however, in septic complications between either of the nutritional support groups and the non-depleted control group. In high risk patients, with weight loss >10% of body weight and over 500 ml blood loss during operation, a significant decrease in major complications was observed (p < 0.05) as a result of nutritional support. We conclude that pre-operative nutritional support, in patients with severe depletion, results in a reduction in major complications to a degree that justifies its routine use in this selected group of patients. In order to reduce protein-energy malnutrition in older people during hospitalisation an early interdisciplinary intervention is needed. We developed a protocol which includes screening for malnutrition, dysphagia and dehydration on admission, followed by immediate interventions.
                To assess effectiveness of the protocol on nutritional status, hospital-acquired infections and pressure sores, and to evaluate the protocol s economical feasibility.
                Prospective, controlled study.
                The inpatient geriatric service of a university hospital (UMC Nijmegen) and a geriatric ward of a non-academic teaching hospital (Rijnstate Hospital, Arnhem).
                298 older patients (>60 years). Methods: One of the geriatric wards applied the protocol (N=140) while the other provided standard care (N=158). All non-terminally ill patients admitted for more than two days were included. Body mass was measured on admittance and discharge and hospital-acquired infections and pressure sores were scored and costs related to nutrition, infections and length of hospital stay were assessed.
                There was a 0.8 kg loss (SEM 0.3 kg) in average weight in the standard care group and a 0.9 kg gain (SEM 0.2 kg) in the intervention group (p<0.001). The number of hospital acquired infections was significantly lower in the intervention group (33/140 versus 58/158, p=0.01) but no significant difference in number of patients with pressure sores (23/140 versus 33/158) was found. Costs were not significantly different: 7516 versus 7908 Euro/patient for intervention versus controls, respectively.
                An early interdisciplinary intervention approach can be effective in reducing protein-energy malnutrition and related hospital-acquired infections and appears to be economically feasible. We examined the effectiveness of a training program for physician-delivered nutrition counseling, alone and in combination with a structured office practice environment for nutrition management, on physicians' counseling practices. Forty-five primary care internists and 1,278 of their patients in the top quarter of the cholesterol distribution at a central Massachusetts health maintenance organization (the Fallon Clinic) were enrolled into a randomized controlled trial. Physicians were randomized by site into three conditions: (1) usual care, (2) physician nutrition counseling training, and (3) physician nutrition counseling training plus a structured office practice environment for nutrition management (prompts and the provision of lipid results and counseling algorithms). A randomly selected 325 patients were given a 10-item patient exit interview (PEI) assessing whether the physician provided advice; assessed past changes, barriers, and resources; negotiated specific plans and goals; provided patient materials; referred the patient to a dietitian; and developed plans for follow-up. Condition 3 physicians demonstrated significantly greater implementation of the nutrition counseling sequence than did physicians in either of the other two conditions (P < .0001). Referrals to nutrition services were markedly reduced in condition 2, despite PEI scores no different than those in condition 1. Higher PEI scores for patients seen by physicians in condition 3 were stable for as long as two years beyond training. Primary care internists, when provided with both training in counseling techniques and a supportive office environment, will carry out patient counseling appropriately. Training alone, however, is not sufficient and may be counterproductive. Medical Subject Headings (MeSH): hypercholesterolemia, diet therapy, coronary disease, health behavior, primary health care, medical education, managed care programs. To validate a nutritional intervention programme for elderly people living in nursing homes.
                In a prospective, randomized, controlled study of 88 residents, we determined nutritional status at day 0 and day 60 using a record of dietary intake, anthropometry, hand-grip strength and mini-nutritional assessment. Dietary intake, grip strength and body weight were also recorded at day 30. We divided subjects into four groups according to their mini-nutritional assessment score. Those with a score 24 received no oral supplementation. Those at risk of malnutrition (with a score of 17-23.5) were randomized to oral supplementation. Those with a score <17 received oral supplementation. We recorded the amount of oral supplements consumed daily.
                Compliance with oral supplementation was good, and daily intake averaged about 400 kcal. The total energy intake on day 60 was significantly higher in both of the groups that received supplements. Following supplementation, most subjects at risk of malnutrition improved their mini-nutritional assessment score and increased their weight (by 1.4 +/- 0.5 kg). Neither the mini-nutritional assessment score nor weight improved in subjects at risk of malnutrition who did not receive supplements. Supplementation in the malnourished group resulted in a mean mini-nutritional assessment score increase (from 13.9 +/- 2.6 to 17.1 +/- 3.9) and a mean weight gain of 1.5 +/- 0.4 kg.
                Oral nutritional supplements are well accepted and result in increased daily protein and energy intake, body weight and nutritional status in most malnourished patients and in those at risk of malnutrition. To evaluate the impact of nutritional supplementation on nutritional status, muscle strength, perceived health, and functional status in a population of community-living, frail, undernourished elderly people.
                A 16-week intervention study in which subjects were randomized to an experimental or a control group and visited in their home on a monthly basis. Outcome variables were measured at the start and end of the study at subjects' homes by a dietitian blinded to treatment assignment.
                83 elderly people (experimental group: n=42; control group: n=41; mean age=80+/-7 years) receiving community home-care services and at high risk for undernutrition.
                Provision of a nutrient-dense protein-energy liquid supplement and encouragement to improve intake from other foods.
                Anthropometric indexes, handgrip strength, isometric elbow flexion and leg extension strength, lower extremity function, perceived health, and functional status.
                Study groups were compared on an "intention to treat" basis using analysis of variance for repeated measures and unpaired and paired t tests and their nonparametric equivalents where appropriate.
                Total energy intake (1,772 vs 1,440 kcal; P<.001) and weight gain (1.62 vs 0.04 kg; P<.001) were higher in the supplemented group. No significant changes were observed with respect to other anthropometric indexes, muscle strength, or functional variables; however, beneficial effects were observed in emotional role functioning (P<0.01) and number of days spent in bed (P=.04).
                Nutrition intervention is feasible in free-living, frail, undernourished elderly people and results in significant improvement of nutritional status with respect to energy and nutrient intake and weight gain. Weight loss can be stopped and in some cases reversed; however, increased physical activity may also be required to improve health and functional status. Although stroke patients who do not have difficulty swallowing may be at risk of undernutrition and worsening nutritional status during hospitalization, optimum methods for nutrition intervention in stroke patients have not been established.
                To examine the feasibility of enteral sip feeding as an effective nutrition intervention after acute stroke.
                Forty-two acute ischemic stroke inpatients with impaired nutritional status who did not have difficulty swallowing within 1 week after the stroke were entered into a single-blind, randomized, controlled, prospective study of enteral sip feeding. Twenty-one patients were randomized to receive daily oral food supplements for 4 weeks in addition to the hospital food, and 21 patients received only the hospital food for the same period. Main outcome measures were energy and protein intakes during the intervention period, change in nutritional status, disability, infective complications, length of stay, and mortality during hospitalization and at 3 months.
                Two patients, one from each group, were lost to follow-up immediately after randomization. Twenty patients received oral nutritional supplementation. The energy intake was significantly greater in the supplemented group: 1807 +/- 318 vs 1084 +/- 343 kcal/d (mean +/- SD; p < .0001) (estimated treatment effect, 723 kcal/d; 95% confidence interval [CI], 498 to 947), as was protein intake: 65.1 +/- 13.8 vs 44.1 +/- 12.8 g/d (p < .001) (estimated treatment effect, 21.0 g/d; 95% CI, 11.7 to 30.3). There also were significant differences between the two groups in the changes in serum albumin and serum iron concentrations between randomization and at follow-up. There was a trend to lower mortality at 3 months in the supplemented group with two deaths (10%) compared with seven deaths (35%) in the control group (p = .127, relative risk, 0.29; 95% CI, 0.07 to 1.21).
                This study suggests that enteral sip feeding is effective in improving nutritional intake and status in stroke patients who do not have swallowing difficulties. There also may be some beneficial effects on clinical outcome, but larger studies are required to confirm this observation and define more precisely the magnitude of any favorable effects. Progressive loss of kidney function results in an increased risk of malnutrition. Despite this, there is little evidence informing the impact of nutrition intervention on predialysis patients with chronic kidney disease (CKD; stages 4 and 5).
                Randomized controlled trial.
                56 outpatients (men, 62%; mean age, 70.7 +/- 14.0 [SD] years) with CKD were randomly allocated to intervention (n = 29) or control (n = 27) by using a concealed computer-generated sequence.
                The intervention group, provided with individualized dietary counseling with regular follow-up aimed at achieving an intake of 0.8 to 1.0 g/kg of protein and greater than 125 kJ/kg of energy, or control, receiving written material only.
                Change in body composition (body cell mass, measured by means of total-body potassium, in 40 of 56 participants), nutritional status (Subjective Global Assessment), and energy and protein intake (3-day food record).
                During the 12 weeks, the intervention group had 3.5% (95% confidence interval, -2.1 to 9.1) less decrease in body cell mass, 17.7-kJ/kg/d (95% confidence interval, 8.2 to 27.2) greater increase in energy intake, greater improvement in Subjective Global Assessment (P < 0.01), and no significant difference in protein intake compared with the control group (-0.04 g/kg/d; 95% confidence interval, -0.73 to 0.16). The intervention was associated with greater increases in energy and protein intake in women than men (interaction P < 0.001 for both).
                Power to detect change in body cell mass, potential bias in ascertainment of Subjective Global Assessment.
                In predialysis patients with CKD, structured nutrition intervention had a greater effect on energy and protein intake in women than men. Additional investigations are warranted to determine the impact on body composition. To assess the effectiveness of an antenatal service using community based breastfeeding peer support workers on initiation of breast feeding.
                Cluster randomised controlled trial.
                Community antenatal clinics in one primary care trust in a multiethnic, deprived population.
                66 antenatal clinics with 2511 pregnant women: 33 clinics including 1140 women were randomised to receive the peer support worker service and 33 clinics including 1371 women were randomised to receive standard care.
                An antenatal peer support worker service planned to comprise a minimum of two contacts with women to provide advice, information, and support from approximately 24 weeks' gestation within the antenatal clinic or at home. The trained peer support workers were of similar ethnic and sociodemographic backgrounds to their clinic population.
                Initiation of breast feeding obtained from computerised maternity records of the hospitals where women from the primary care trust delivered.
                The sample was multiethnic, with only 9.4% of women being white British, and 70% were in the lowest 10th for deprivation. Most of the contacts with peer support workers took place in the antenatal clinics. Data on initiation of breast feeding were obtained for 2398 of 2511 (95.5%) women (1083/1140 intervention and 1315/1371 controls). The groups did not differ for initiation of breast feeding: 69.0% (747/1083) in the intervention group and 68.1% (896/1315) in the control groups; cluster adjusted odds ratio 1.11 (95% confidence interval 0.87 to 1.43). Ethnicity, parity, and mode of delivery independently predicted initiation of breast feeding, but randomisation to the peer support worker service did not.
                A universal service for initiation of breast feeding using peer support workers provided within antenatal clinics serving a multiethnic, deprived population was ineffective in increasing initiation rates.
                Current Controlled Trials ISRCTN16126175. Cancer patients, assessed as nutritionally at risk, were randomly assigned to a control group or to one of four intervention groups receiving (a) nutritional supplementation, (b) relaxation training, (c) both nutritional supplementation and relaxation training, or (d) neither nutritional supplementation nor relaxation training. Fifty-five subjects completed a four-month intervention period during which they were visited biweekly by a nurse (except control subjects). In repeated measures analyses of variance, significant group-by-time interactions were obtained for weight and arm muscle circumference (a measure of protein stores), indicating that for these measures the groups changed differentially during the intervention period. The group-by-time interaction approached significance on the Karnofsky Performance Status Scale. For all three variables, gain was greatest for the relaxation group; the most severe loss occurred in the control group. These findings suggest that the cachexia of cancer may be slowed or reversed through noninvasive nursing interventions. To determine whether oral protein energy supplements, used long term in children with cystic fibrosis who are moderately malnourished, improve nutritional and other outcomes.
                Multicentre randomised controlled trial.
                Seven specialist paediatric cystic fibrosis centres and their associated shared care clinics and seven smaller paediatric cystic fibrosis clinics.
                102 children with cystic fibrosis, aged between 2 and 15 years, who were moderately malnourished.
                Oral protein energy supplements in addition to usual dietary advice compared with dietary advice alone, for 12 months.
                Change in body mass index centile over one year.
                Use of supplements was not associated with a change in body mass index centile (mean difference 2.99 centile points, 95% confidence interval -2.70 to 8.68) or other nutritional and spirometric outcomes in this group of children.
                Long term use of oral protein energy supplements did not result in an improvement in nutritional status or other clinical outcomes in children with cystic fibrosis who were moderately malnourished. Oral protein energy supplements should not be regarded as an essential part of the management of this group of children.
                ISRCTN: 95744468.
Weak evidence exists for the effectiveness of protein and energy feeds. Adequately sized randomised trials with robust methodology are required. In particular, the role of dietetic assistants, and peripheral venous feeding require further evaluation.