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Summary Background Obesity is a common cause of non-communicable disease. Guidelines recommend that physicians screen and offer brief advice to motivate weight loss through referral to behavioural weight loss programmes. However, physicians rarely intervene and no trials have been done on the subject. We did this trial to establish whether physician brief intervention is acceptable and effective for reducing bodyweight in patients with obesity. Methods In this parallel, two-arm, randomised trial, patients who consulted 137 primary care physicians in England were screened for obesity. Individuals could be enrolled if they were aged at least 18 years, had a body-mass index of at least 30 kg/m2 (or at least 25 kg/m2 if of Asian ethnicity), and had a raised body fat percentage. At the end of the consultation, the physician randomly assigned participants (1:1) to one of two 30 s interventions. Randomisation was done via preprepared randomisation cards labelled with a code representing the allocation, which were placed in opaque sealed envelopes and given to physicians to open at the time of treatment assignment. In the active intervention, the physician offered referral to a weight management group (12 sessions of 1 h each, once per week) and, if the referral was accepted, the physician ensured the patient made an appointment and offered follow-up. In the control intervention, the physician advised the patient that their health would benefit from weight loss. The primary outcome was weight change at 12 months in the intention-to-treat population, which was assessed blinded to treatment allocation. We also assessed asked patients' about their feelings on discussing their weight when they have visited their general practitioner for other reasons. Given the nature of the intervention, we did not anticipate any adverse events in the usual sense, so safety outcomes were not assessed. This trial is registered with the ISRCTN Registry, number ISRCTN26563137. Findings Between June 4, 2013, and Dec 23, 2014, we screened 8403 patients, of whom 2728 (32%) were obese. Of these obese patients, 2256 (83%) agreed to participate and 1882 were eligible, enrolled, and included in the intention-to-treat analysis, with 940 individuals in the support group and 942 individuals in the advice group. 722 (77%) individuals assigned to the support intervention agreed to attend the weight management group and 379 (40%) of these individuals attended, compared with 82 (9%) participants who were allocated the advice intervention. In the entire study population, mean weight change at 12 months was 2·43 kg with the support intervention and 1·04 kg with the advice intervention, giving an adjusted difference of 1·43 kg (95% CI 0·89–1·97). The reactions of the patients to the general practitioners' brief interventions did not differ significantly between the study groups in terms of appropriateness (adjusted odds ratio 0·89, 95% CI 0·75–1·07, p=0·21) or helpfulness (1·05, 0·89–1·26, p=0·54); overall, four (<1%) patients thought their intervention was inappropriate and unhelpful and 1530 (81%) patients thought it was appropriate and helpful. Interpretation A behaviourally-informed, very brief, physician-delivered opportunistic intervention is acceptable to patients and an effective way to reduce population mean weight. Funding The UK National Prevention Research Initiative.

The Lancet (British edition), 2016-11, Vol.388 (10059), p.2492-2500

Screening and brief intervention for obesity in primary care: a parallel, two-arm, randomised trial

Summary Background Evidence 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. Methods In 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. Findings Between 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). Interpretation For 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. Funding National Prevention Research Initiative, Weight Watchers International (as part of an UK Medical Research Council Industrial Collaboration Award).

The Lancet (British edition), 2017-06, Vol.389 (10085), p.2214-2225

Extended and standard duration weight-loss programme referrals for adults in primary care (WRAP): a randomised controlled trial

Abstract Background Helping smokers from disadvantaged backgrounds to reduce their smoking could result in more quit attempts and successful quitting, which in turn could help to tackle health inequalities. No study has assessed the effects of exercise counselling (delivered by health trainers) on smoking reduction and quitting, among hard-to-reach smokers. We aimed to assess recruitment methods in a trial targeting hard-to-reach smokers who wished to reduce but not quit smoking, without using nicotine replacement therapy. Methods The Exercise Assisted Reduction then Stop (EARS) pilot randomised trial was set up to examine the feasibility and acceptability of trial methods and 8-week intervention, with follow-up assessments up to 16 weeks, and primary outcome being 4-week post-quit abstinence confirmed by expired air CO. Patients were allocated to treatment or usual care (advice to quit) with a password protected web-based randomisation system set up and managed by the UK Clinical Research Collaboration's accredited Peninsula Clinical Trials Unit. Randomisation was 1:1 and minimised by age, sex, health trainer (one of three), and smoking dependence level. To maintain concealment, the minimisation algorithm retained a stochastic element. Follow-up assessments were done by a researcher who also provided the intervention (for those receiving exercise assisted reduction), and were therefore not masked to treatment. This method was used to maximise data collection within a hard-to-reach population. We focused recruitment on individuals from two socially deprived wards in Plymouth (ie, in the top 3% most deprived areas in England). Three main approaches were tested: invitation letter (and reminder note plus phone calls) to known smokers without contraindications to do moderate physical activity, through (1) primary care, or (2) stop smoking services (SSS; targeting failed quitters in the previous 2 years); or (3) other community-based approaches such as audio and written media, posters, third-sector networking (eg, housing trusts), opportunistic recruitment (eg, outside job centre), workplaces with high proportion of low-skilled employees, and attending local events and centres. We compared recruitment rates through each of the three settings. For non-normally distributed data we present medians and IQRs. Findings We recruited 99 smokers (between May, 2011, and May, 2012), of whom 46 (46%) were unemployed and 45 (45%) in social class C2–E, and 41 (41%) were moderately or extremely anxious or depressed (from item 5 of EQ-5D). The sample had a mean age of 47·2 years (SD 11·3), median school leaving age of 16·0 years (IQR 15·0–16·0), initial smoking age of 14 years (13·0–16·0) years, equivalent cigarettes smoked per day of 19·1 (14·4–24·4), and a mean Fagerstrom test for nicotine dependence score of 5·6 (SD 2·1). Recruitment resulting from invitation letters from GPs and SSS were similar and ranged from 5·1–11·1% depending on the effort invested in follow-up phone calls. Overall, 62 (63%) participants were randomly assigned from GP invitations and 31 (31%) from SSS invitations. Despite substantial effort, only six (6%) of the total sample were recruited via other community approaches. Those recruited via primary care and SSS did not differ in any background variable, and we had insufficient data from other community approaches for comparison. Interpretation We matched our targets for recruiting hard-to-reach smokers into a randomised trial, and identified the probable recruitment rates for three different approaches. The most effective approach was by mailed invitation letter, with follow-up phone calls roughly doubling the recruitment rate, but with considerable additional effort. Data captured in the pilot study will establish whether recruitment approach was related to study retention and effects of the intervention. Funding National Institute for Health Research (Health Technology Assessment) in the UK, SmokeFree South West, and Plymouth Primary Care Trust.

The Lancet (British edition), 2012-11, Vol.380, p.S73-S73

Strategies to recruit hard-to-reach smokers into Exercise Assisted Reduction then Stop (EARS): a pragmatic pilot randomised trial

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Screening and brief intervention for obesity in primary care: a parallel, two-arm, randomised trial

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Extended and standard duration weight-loss programme referrals for adults in primary care (WRAP): a randomised controlled trial

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Strategies to recruit hard-to-reach smokers into Exercise Assisted Reduction then Stop (EARS): a pragmatic pilot randomised trial

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