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A pragmatic randomised controlled trial in primary care of the Camden Weight Loss (CAMWEL) programme.

ABSTRACT: To evaluate effectiveness of a structured one-to-one behaviour change programme on weight loss in obese and overweight individuals.Randomised controlled trial.23 general practices in Camden, London.381 adults with body mass index ?25 kg/m(2) randomly assigned to intervention (n=191) or control (n=190) group.A structured one-to-one programme, delivered over 14 visits during 12 months by trained advisors in three primary care centres compared with usual care in general practice.Changes in weight, per cent body fat, waist circumference, blood pressure and heart rate between baseline and 12 months.217/381 (57.0%) participants were assessed at 12 months: missing values were imputed. The difference in mean weight change between the intervention and control groups was not statistically significant (0.70 kg (0.67 to 2.17, p=0.35)), although a higher proportion of the intervention group (32.7%) than the control group (20.4%) lost 5% or more of their baseline weight (OR: 1.80 (1.02 to 3.18, p=0.04)). The intervention group achieved a lower mean heart rate (mean difference 3.68 beats per minute (0.31 to 7.04, p=0.03)) than the control group. Participants in the intervention group reported higher satisfaction and more positive experiences of their care compared with the control group.Although there is no significant difference in mean weight loss between the intervention and control groups, trained non-specialist advisors can deliver a structured programme and achieve clinically beneficial weight loss in some patients in primary care. The intervention group also reported a higher level of satisfaction with the support received. Primary care interventions are unlikely to be sufficient to tackle the obesity epidemic and effective population-wide measures are also necessary.Trial registrationClincaltrials.gov NCT00891943.

SUBMITTER: Nanchahal K

PROVIDER: S-EPMC3353130 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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A pragmatic randomised controlled trial in primary care of the Camden Weight Loss (CAMWEL) programme.

Nanchahal Kiran K Power Tom T Holdsworth Elizabeth E Hession Michelle M Sorhaindo Annik A Griffiths Ulla U Townsend Joy J Thorogood Nicki N Haslam David D Kessel Anthony A Ebrahim Shah S Kenward Mike M Haines Andrew A

BMJ open 20120504 3

<h4>Objectives</h4>To evaluate effectiveness of a structured one-to-one behaviour change programme on weight loss in obese and overweight individuals.<h4>Design</h4>Randomised controlled trial.<h4>Setting</h4>23 general practices in Camden, London.<h4>Participants</h4>381 adults with body mass index ≥25 kg/m(2) randomly assigned to intervention (n=191) or control (n=190) group.<h4>Interventions</h4>A structured one-to-one programme, delivered over 14 visits during 12 months by trained advisors i ...[more]

PMID: 22561352

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Project description:BackgroundEvidence exist that primary care referral to an open-group behavioural programme is an effective strategy for management of obesity, but little evidence on optimal intervention duration is available. We aimed to establish whether 52-week referral to an open-group weight-management programme would achieve greater weight loss and improvements in a range of health outcomes and be more cost-effective than the current practice of 12-week referrals.MethodsIn this non-blinded, parallel-group, randomised controlled trial, we recruited participants who were aged 18 years or older and had body-mass index (BMI) of 28 kg/m2 or higher from 23 primary care practices in England. Participants were randomly assigned (2:5:5) to brief advice and self-help materials, a weight-management programme (Weight Watchers) for 12 weeks, or the same weight-management programme for 52 weeks. We followed-up participants over 2 years. The primary outcome was weight at 1 year of follow-up, analysed with mixed-effects models according to intention-to-treat principles and adjusted for centre and baseline weight. In a hierarchical closed-testing procedure, we compared combined behavioural programme arms with brief intervention, then compared the 12-week programme and 52-week programme. We did a within-trial cost-effectiveness analysis using person-level data and modelled outcomes over a 25-year time horizon using microsimulation. This study is registered with Current Controlled Trials, number ISRCTN82857232.FindingsBetween Oct 18, 2012, and Feb 10, 2014, we enrolled 1269 participants. 1267 eligible participants were randomly assigned to the brief intervention (n=211), the 12-week programme (n=528), and the 52-week programme (n=528). Two participants in the 12-week programme had been found to be ineligible shortly after randomisation and were excluded from the analysis. 823 (65%) of 1267 participants completed an assessment at 1 year and 856 (68%) participants at 2 years. All eligible participants were included in the analyses. At 1 year, mean weight changes in the groups were -3·26 kg (brief intervention), -4·75 kg (12-week programme), and -6·76 kg (52-week programme). Participants in the behavioural programme lost more weight than those in the brief intervention (adjusted difference -2·71 kg, 95% CI -3·86 to -1·55; p<0·0001). The 52-week programme was more effective than the 12-week programme (-2·14 kg, -3·05 to -1·22; p<0·0001). Differences between groups were still significant at 2 years. No adverse events related to the intervention were reported. Over 2 years, the incremental cost-effectiveness ratio (ICER; compared with brief intervention) was £159 per kg lost for the 52-week programme and £91 per kg for the 12-week programme. Modelled over 25 years after baseline, the ICER for the 12-week programme was dominant compared with the brief intervention. The ICER for the 52-week programme was cost-effective compared with the brief intervention (£2394 per quality-adjusted life-year [QALY]) and the 12-week programme (£3804 per QALY).InterpretationFor adults with overweight or obesity, referral to this open-group behavioural weight-loss programme for at least 12 weeks is more effective than brief advice and self-help materials. A 52-week programme produces greater weight loss and other clinical benefits than a 12-week programme and, although it costs more, modelling suggests that the 52-week programme is cost-effective in the longer term.FundingNational Prevention Research Initiative, Weight Watchers International (as part of an UK Medical Research Council Industrial Collaboration Award).

Project description:OBJECTIVE:To determine the effectiveness of a novel interdisciplinary treatment compared with usual care on weight loss in overweight and obese adult volunteers. DESIGN:Single blinded controlled trial. Participants randomly assigned to usual care (C, general guideline-based diet and exercise advice), intervention (I, interdisciplinary protocol) or intervention + a healthy food supplement (30 g walnuts/day) (IW). SETTING:Community based study, Illawarra region, south of Sydney, Australia. PARTICIPANTS:Generally well volunteer adult residents, 25-54 years, body mass index (BMI) 25-40kg/m2 were eligible. At baseline 439 were assessed, 377 were randomised, 298 completed the 3-month intensive phase and 178 completed the 12-month follow-up. INTERVENTIONS:Treatment was provided at clinic visits intensively (0 months, 1 month, 2 months, 3 months) then quarterly to 12 months. Support phone calls were quarterly. All participants underwent blinded assessments for diet, exercise and psychological status. PRIMARY AND SECONDARY MEASURES:The primary outcome was difference in weight loss between baseline and 12 months (clinically relevant target 5% loss). Secondary outcomes were changes in blood pressure, fasting blood glucose and lipids, and changes in diet, exercise and psychological parameters. RESULTS:At 12 months, differences in weight loss were identified (p<0.001). The I group lost more than controls at 3 months (91.11 (92.23,90.00), p<0.05) and the IW more than controls at 3 months (91.25 (92.35,90.15), p<0.05) and 6 months (92.20 (93.90,90.49), p<0.01). The proportion achieving 5% weight loss was significantly different at 3 months, 6 months and 9 months (p=0.04, p=0.03, p=0.03), due to fewer controls on target at 3 months, 6 months and 9 months and more IW participants at 6 months. Reductions in secondary outcomes (systolic blood pressure, blood glucose/lipid parameters and lifestyle measures) followed the pattern of weight loss. CONCLUSIONS:An interdisciplinary intervention produced greater and more clinically significant and sustained weight loss compared with usual care. The intensive phase was sufficient to reach clinically relevant targets, but long-term management plans may be required. TRIAL REGISTRATION NUMBER:ANZCTRN 12614000581662; Post-results.

Project description:BackgroundThe increasing prevalence of overweight and obesity needs effective approaches for weight loss in primary care and community settings. We compared weight loss with standard treatment in primary care with that achieved after referral by the primary care team to a commercial provider in the community.MethodsIn this parallel group, non-blinded, randomised controlled trial, 772 overweight and obese adults were recruited by primary care practices in Australia, Germany, and the UK. Participants were randomly assigned with a computer-generated simple randomisation sequence to receive either 12 months of standard care as defined by national treatment guidelines, or 12 months of free membership to a commercial programme (Weight Watchers), and followed up for 12 months. The primary outcome was weight change over 12 months. Analysis was by intention to treat (last observation carried forward [LOCF] and baseline observation carried forward [BOCF]) and in the population who completed the 12-month assessment. This trial is registered, number ISRCTN85485463.Findings377 participants were assigned to the commercial programme, of whom 230 (61%) completed the 12-month assessment; and 395 were assigned to standard care, of whom 214 (54%) completed the 12-month assessment. In all analyses, participants in the commercial programme group lost twice as much weight as did those in the standard care group. Mean weight change at 12 months was -5·06 kg (SE 0·31) for those in the commercial programme versus -2·25 kg (0·21) for those receiving standard care (adjusted difference -2·77 kg, 95% CI -3·50 to -2·03) with LOCF; -4·06 kg (0·31) versus -1·77 kg (0·19; adjusted difference -2·29 kg, -2·99 to -1·58) with BOCF; and -6·65 kg (0·43) versus -3·26 kg (0·33; adjusted difference -3·16 kg, -4·23 to -2·11) for those who completed the 12-month assessment. Participants reported no adverse events related to trial participation.InterpretationReferral by a primary health-care professional to a commercial weight loss programme that provides regular weighing, advice about diet and physical activity, motivation, and group support can offer a clinically useful early intervention for weight management in overweight and obese people that can be delivered at large scale.FundingWeight Watchers International, through a grant to the UK Medical Research Council.

Project description:BACKGROUND:Obesity is a major risk factor behind some of the most common problems encountered in primary care. Although effective models for obesity treatment have been developed, the 'reach' of these interventions is poor and only a small fraction of primary care patients receive evidence-based treatment. The purpose of this study is to identify factors that impact the uptake (reach) of an evidence-based obesity treatment program within the context of a pragmatic cluster randomized controlled trial comparing three models of care delivery. METHODS:Recruitment and reach were evaluated by the following measures: 1) mailing response rates, 2) referral sources among participants contacting the study team, 3) eligibility rates, 4) participation rates, and 5) representativeness based on demographics, co-morbid conditions, and healthcare utilization of 1432 enrolled participants compared to >?17,000 non-participants from the clinic-based patient populations. Referral sources and participation rates were compared across study arms and level of clinic engagement. RESULTS:The response rate to clinic-based mailings was 13.2% and accounted for 66% of overall program recruitment. An additional 22% of recruitment came from direct clinic referrals and 11% from media, family, or friends. Of those screened, 87% were eligible; among those eligible, 86% enrolled in the trial. Participation rates did not vary across the three care delivery arms, but were higher at clinics with high compared to low provider involvement. In addition, clinics with high provider involvement had a higher rate of in clinic referrals (33% versus 16%) and a more representative sample with regards to BMI, rurality, and months since last clinic visit. However, across clinics, enrolled participants compared to non-participants were older, more likely to be female, more likely to have had a joint replacement but less likely to have CVD or smoke, and had fewer hospitalizations. CONCLUSIONS:A combination of direct patient mailings and in-clinic referrals may enhance the reach of primary care behavioral weight loss interventions, although more proactive outreach is likely necessary for men, younger patients, and those at greater medial risk. Strategies are needed to enhance provider engagement in referring patients to behavioral weight loss programs. TRIAL REGISTRATION:clnicialtrials.gov NCT02456636. Registered May 28, 2015, https://www.clinicaltrials.gov/ct2/results?cond=&term=RE-POWER&cntry=&state=&city=&dist=.

Project description:ObjectivesTo study the cost-effectiveness of a care manager organization for patients with mild to moderate depression in Swedish primary care in a 12-month perspective.MethodsCost-effectiveness analysis of the care manager organization compared to care as usual (CAU) in a pragmatic cluster randomised controlled trial including 192 individuals in the care manager group and 184 in the CAU group. Cost-effectiveness was assessed from a health care and societal perspectives. Costs were assessed in relation to two different health outcome measures: depression free days (DFDs) and quality adjusted life years (QALYs).ResultsAt the 12-month follow-up, patients treated at the intervention Primary Care Centres (PCCs) with a care manager organization had larger health benefits than the group receiving usual care only at control PCCs. Mean QALY per patient was 0.73 (95% CI 0.7; 0.75) in the care manager group compared to 0.70 (95% CI 0.66; 0.73) in the CAU group. Mean DFDs was 203 (95% CI 178; 229) in the care manager group and 155 (95% CI 131; 179) in the CAU group. Further, from a societal perspective, care manager care was associated with a lower cost than care as usual, resulting in a dominant incremental cost-effectiveness ratio (ICER) for both QALYs and DFDs. From a health care perspective care manager care was related to a low cost per QALY (36,500 SEK / €3,379) and DFD (31 SEK/€3).LimitationsA limitation is the fact that QALY data was impaired by insufficient EQ-5D data for some patients.ConclusionsA care manager organization at the PCC to increase quality of care for patients with mild-moderate depression shows high health benefits, with no decay over time, and high cost-effectiveness both from a health care and a societal perspective. Trial registration details: The trial was registered in ClinicalTrials.com ( https://clinicaltrials.gov/ct2/show/NCT02378272 ) in 02/02/2015 with the registration number NCT02378272. The first patient was enrolled in 11/20/2014.

Project description:IntroductionMen who are overweight or obese in the rural Midwestern USA are an unrepresented, at-risk group exhibiting rising rates of cardiovascular disease, poor access to preventive care and poor lifestyle behaviours that contribute to sedentary lifestyle and unhealthy diet. Self-monitoring of eating and activity has demonstrated efficacy for weight loss. Use of mobile technologies for self-monitoring eating and activity may address rural men's access disparities to preventive health resources and support weight loss. Our pilot trial will assess the feasibility and acceptability of two mobile applications for weight loss in rural men to inform a future, full-scale trial.Methods and analysisA 6-month randomised controlled trial with contextual evaluation will randomise 80 men using a 1:1 ratio to either a Mobile Technology Plus (MT+) intervention or a basic Mobile Technology (MT) intervention in rural, midlife men (aged 40-69 years). The MT+ intervention consists of a smartphone self-monitoring application enhanced with discussion group (Lose-It premium), short message service text-based support and Wi-Fi scale. The MT group will receive only a self-monitoring application (Lose-It basic). Feasibility and acceptability will be evaluated using number of men recruited and retained, and evaluative focus group feedback. We seek to determine point estimates and variability of outcome measures of weight loss (kg and % body weight) and improved dietary and physical activity behaviours (Behavioral Risk Factor Surveillance System (BRFSS) physical activity and fruit and vegetable consumption surveys, data from Lose-It! application (kcal/day, steps/day)). Community capacity will be assessed using standard best practice methods. Descriptive content analysis will evaluate intervention acceptability and contextual sensitivity.Ethics and disseminationThis protocol was approved by the University of Nebraska Medical Center Institutional Review Board (IRB# 594-17-EP). Dissemination of findings will occur through ClinicalTrials.gov and publish pilot data to inform the design of a larger clinical trial.Trial registration numberNCT03329079; preresults. Protocol V.10, study completion date 31 August 2020. Roles and responsibilities funder: NIH/NINR Health Disparities Section 1R15NR017522-01.

Project description:ObjectiveTo evaluate the effectiveness of different brief intervention strategies at reducing hazardous or harmful drinking in primary care. The hypothesis was that more intensive intervention would result in a greater reduction in hazardous or harmful drinking.DesignPragmatic cluster randomised controlled trial.SettingPrimary care practices in the north east and south east of England and in London.Participants3562 patients aged 18 or more routinely presenting in primary care, of whom 2991 (84.0%) were eligible to enter the trial: 900 (30.1%) screened positive for hazardous or harmful drinking and 756 (84.0%) received a brief intervention. The sample was predominantly male (62%) and white (92%), and 34% were current smokers.InterventionsPractices were randomised to three interventions, each of which built on the previous one: a patient information leaflet control group, five minutes of structured brief advice, and 20 minutes of brief lifestyle counselling. Delivery of the patient leaflet and brief advice occurred directly after screening and brief lifestyle counselling in a subsequent consultation.Main outcome measuresThe primary outcome was patients' self reported hazardous or harmful drinking status as measured by the alcohol use disorders identification test (AUDIT) at six months. A negative AUDIT result (score <8) indicated non-hazardous or non-harmful drinking. Secondary outcomes were a negative AUDIT result at 12 months, experience of alcohol related problems (alcohol problems questionnaire), health utility (EQ-5D), service utilisation, and patients' motivation to change drinking behaviour (readiness to change) as measured by a modified readiness ruler.ResultsPatient follow-up rates were 83% at six months (n=644) and 79% at 12 months (n=617). At both time points an intention to treat analysis found no significant differences in AUDIT negative status between the three interventions. Compared with the patient information leaflet group, the odds ratio of having a negative AUDIT result for brief advice was 0.85 (95% confidence interval 0.52 to 1.39) and for brief lifestyle counselling was 0.78 (0.48 to 1.25). A per protocol analysis confirmed these findings.ConclusionsAll patients received simple feedback on their screening outcome. Beyond this input, however, evidence that brief advice or brief lifestyle counselling provided important additional benefit in reducing hazardous or harmful drinking compared with the patient information leaflet was lacking.Trial registrationCurrent Controlled Trials ISRCTN06145674.

Dataset Information

A pragmatic randomised controlled trial in primary care of the Camden Weight Loss (CAMWEL) programme.

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A pragmatic randomised controlled trial in primary care of the Camden Weight Loss (CAMWEL) programme.

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