BackgroundAn increasing number of people require help to manage their weight. The NHS recommends weight loss advice by general practitioners and/or a referral to a practice nurse. Although this is helpful for some, more effective approaches that can be disseminated economically on a large scale are needed.ObjectiveTo assess whether or not a task-based weight management programme [Weight Action Programme (WAP)] has better long-term effects than a ‘best practice’ intervention provided in primary care by practice nurses.DesignRandomised controlled trial with cost-effectiveness analysis.SettingGeneral practices in east London, UK.ParticipantsThree hundred and thirty adults with a body mass index (BMI) of ≥ 30 kg/m2or a BMI of ≥ 28 kg/m2plus comorbidities were recruited from local general practices and via media publicity. Those who had a BMI of > 45 kg/m2, had lost > 5% of their body weight in the previous 6 months, were currently pregnant or taking psychiatric medications were excluded. Participants were randomised (2 : 1) to the WAP or nurse arms.InterventionsThe WAP intervention was delivered in eight weekly group sessions that combined dietary and physical activity, advice and self-monitoring in a group-oriented intervention. The initial course was followed by 10 monthly group maintenance sessions open to all participants in this study arm. The practice nurse intervention (best usual care) consisted of four one-to-one sessions delivered over 8 weeks, and included standard advice on diet and physical activity based on NHS ‘Change4Life’ materials and motivational support.Main outcome measuresThe primary outcome measure was weight change at 12 months. Secondary outcome measures included change in BMI, waist circumference and blood pressure, and proportion of participants losing at least 5% and 10% of baseline body weight. Staff collecting measurements at the 6- and 12-month follow-ups were blinded to treatment allocation. The primary outcome measure was analysed according to the intention-to-treat principle, and included all participants with at least one recorded outcome at either 1, 2, 6 or 12 months. The analysis employed a mixed-effects linear regression model, adjusted for baseline weight, age, sex, ethnicity, smoking status and general practice. The European Quality of Life-5 Dimensions-5 Levels questionnaire was completed and used to estimate quality-adjusted life-years (QALYs) within the cost-effectiveness analysis.ResultsThere were 330 participants (WAP arm,n = 221; nurse arm,n = 109; 72% women). A total of 291 (88%) participants (WAP arm,n = 194; nurse arm,n = 97) were included in the main analysis for the primary outcome. Weight loss at 12 months was greater in the WAP arm than in the nurse intervention arm [–4.2 kg vs. –2.3 kg; difference –1.9 kg, 95% confidence interval (CI) –3.7 to –0.1 kg;p = 0.04]. Participants in the WAP arm were more likely than participants in the nurse arm to have lost at least 5% of their baseline body weight at 12 months (41% vs. 27%; odds ratio 14.61, 95% CI 2.32 to 91.96;p = 0.004). The incremental cost-effectiveness ratio for WAP over and above the nurse arm is £7742 per QALY.ConclusionsA WAP delivered in general practice better promotes weight loss over 12 months than a best usual practice nurse-led weight loss programme.LimitationsThe trial recruited mostly women. Research is needed into factors that would make weight loss programmes more attractive to men.Trial registrationCurrent Controlled Trials ISRCTN45820471.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 79. See the NIHR Journals Library website for further project information.

Background Tobacco smoking remains the leading cause of preventable death and disease worldwide. Digital interventions delivered through smartphones offer a promising alternative to traditional methods, but little is known about their effectiveness. Objective Our objective was to test the preliminary effectiveness of Quit Genius, a novel digital therapeutic intervention for smoking cessation. Methods A 2-arm, single-blinded, parallel-group randomized controlled trial design was used. Participants were recruited via referrals from primary care practices and social media advertisements in the United Kingdom. A total of 556 adult smokers (aged 18 years or older) smoking at least 5 cigarettes a day for the past year were recruited. Of these, 530 were included for the final analysis. Participants were randomized to one of 2 interventions. Treatment consisted of a digital therapeutic intervention for smoking cessation consisting of a smartphone app delivering cognitive behavioral therapy content, one-to-one coaching, craving tools, and tracking capabilities. The control intervention was very brief advice along the Ask, Advise, Act model. All participants were offered nicotine replacement therapy for 3 months. Participants in a random half of each arm were pseudorandomly assigned a carbon monoxide device for biochemical verification. Outcomes were self-reported via phone or online. The primary outcome was self-reported 7-day point prevalence abstinence at 4 weeks post quit date. Results A total of 556 participants were randomized (treatment: n=277; control: n=279). The intention-to-treat analysis included 530 participants (n=265 in each arm; 11 excluded for randomization before trial registration and 15 for protocol violations at baseline visit). By the quit date (an average of 16 days after randomization), 89.1% (236/265) of those in the treatment arm were still actively engaged. At the time of the primary outcome, 74.0% (196/265) of participants were still engaging with the app. At 4 weeks post quit date, 44.5% (118/265) of participants in the treatment arm had not smoked in the preceding 7 days compared with 28.7% (76/265) in the control group (risk ratio 1.55, 95% CI 1.23-1.96; P<.001; intention-to-treat, n=530). Self-reported 7-day abstinence agreed with carbon monoxide measurement (carbon monoxide <10 ppm) in 96% of cases (80/83) where carbon monoxide readings were available. No harmful effects of the intervention were observed. Conclusions The Quit Genius digital therapeutic intervention is a superior treatment in achieving smoking cessation 4 weeks post quit date compared with very brief advice. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN) 65853476; https://www.isrctn.com/ISRCTN65853476

Objective The 5:2 diet is a popular intermittent energy restriction method of weight management that awaits further evaluation. We compared the effects of one-off 5:2 instructions with the effects of one-off standard multicomponent weight-management advice; and also examined whether additional behavioural support enhances 5:2 adherence and efficacy compared to one-off instructions. Methods Three hundred adults with obesity were randomised to receive a Standard Brief Advice (SBA) covering diet and physical activity (N = 100); 5:2 self-help instructions (5:2SH) (N = 100); or 5:2SH plus six once-weekly group support sessions (N = 100). Participants were followed up for one year. Results Adherence to 5:2SH was initially high (74% at 6 weeks), but it declined over time (31% at 6 months and 22% at one year). 5:2SH and SBA achieved similar weight-loss at six months (-1.8kg (SD = 3.5) vs -1.7kg (SD = 4.4); b = 0.23, 95%CI:-0.79–1.27, p = 0.7) and at one year (-1.9kg (SD = 4.9) vs -1.8kg (SD = 5.7), b = 0.20, 95%CI:-1.21–1.60, p = 0.79), with 18% vs 15% participants losing ≥5% of their body weight with 5:2SH and SBA, respectively at one year (RR = 0.83, 95%CI:0.44–1.54, p = 0.55). Both interventions received positive ratings, but 5:2SH ratings were significantly higher. 5:2SH had no negative effect on fat and fiber intake and physical activity compared to SBA. Compared to 5:2SH, 5:2G generated a greater weight loss at 6 weeks (-2.3kg vs -1.5kg; b = 0.74, 95%CI:1.37–0.11, p = 0.02), but by one year, the difference was no longer significant (-2.6kg vs -1.9kg, p = 0.37; ≥5% body weight loss 28% vs 18%, p = 0.10). Conclusions Simple 5:2 advice and multicomponent weight management advice generated similar modest results. The 5:2 diet did not undermine other health behaviours, and it received more favourable ratings. Adding initial group support enhanced 5:2 adherence and effects, but the impact diminished over time. Health professionals who provide brief weight management advice may consider including the 5:2 advice as an option. Trial registration ISRCTN registry (ISRCTN79408248).

Introduction This study evaluated the secondary effectiveness outcomes for Quit Genius, a digital clinician-assisted cognitive behavioral therapy (CBT) intervention for smoking cessation. Methods Adult smokers (N=556) were randomly assigned to Quit Genius (n=277), a digital, clinician-assisted CBT intervention or Very Brief Advice (VBA) to stop smoking, an evidence-based, 30-second intervention designed to facilitate quit attempts, coupled with referral to a cessation service (n=279). Participants were offered combination nicotine replacement therapy (patches and gum) tailored to individual nicotine dependence. Analyses (N=530), by intention-to-treat, compared Quit Genius and VBA at 4, 26, and 52 weeks post-quit date. The primary outcome was self-reported seven-day point prevalence abstinence at 4 weeks post-quit date. Consecutive seven-day point-prevalence abstinence, defined as abstinent at two or more consecutive timepoints, was examined at weeks 26 and 52 to indicate long-term effectiveness. Abstinence was verified using a random sample of participants with carbon monoxide breath testing of &lt;5 parts per million (n=280). Results Self-reported consecutive seven-day point prevalence abstinence at weeks 26 and 52 for Quit Genius was 27.2% and 22.6% respectively, compared to VBA which was 16.6% and 13.2% (RR=1.70,95% CI,1.22-2.37;p=0.003, 26 weeks; RR=1.71,95% CI,1.17-2.50; p=0.005, 52 weeks). Biochemically verified abstinence was significantly different at 26- (p=0.03) but not 52 weeks (p=0.16). Quit Genius participants were more likely to remain abstinent than those who received VBA (RR=1.71,95% CI 1.17-2.50;p=0.005). Conclusions This study provides secondary evidence for the long-term effectiveness of Quit Genius in comparison with VBA. Future trials of digital interventions without clinician support and comparisons with active treatment are needed. Implications The long-term effectiveness of clinician-assisted digital smoking cessation interventions has not been well-studied. This study established the long-term effectiveness of an extended CBT-based intervention; results may inform implementation of scalable approaches to smoking cessation in the health system.

ObjectivesSmokers who use e-cigarettes (EC) do so mostly to stop smoking, but many continue to use both products. It is not known whether these ‘dual users’ are interested in stop-smoking medications and whether they can benefit from them.Setting, participants and measuresDual users were recruited over social media and posted study questionnaire and saliva kits at baseline, 3 and 6 months. Those interested in varenicline were posted the medication and received weekly calls over the first 6 weeks, followed by three calls at fortnightly intervals.ResultsOf 204 participants, 124 (61%, CI=54% to 68%) expressed interest in receiving varenicline and 80 (39%, CI=32% to 45%) started varenicline (varenicline users, VU). VU were more dependent smokers (F=6.2, p=0.01) with higher cigarette consumption (F=8.7, p<0.01) who were using stronger nicotine e-liquids (F=13.9, p<0.001) than dual users not opting for varenicline (varenicline non-users, VN). In terms of abstinence for at least 3 months at the 6-month follow-up, VU were more likely than VN to report abstinence from smoking (17.5% vs 4.8%, p=0.006, RR=3.6, CI:1.4 to 9.0), vaping (12.5% vs 1.6%, p=0.007, RR=7.8, CI:1.7 to 34.5) and both smoking and vaping (8.8% vs 0.8%, p=0.02, RR=10.9, CI:1.4 to 86.6). The differences were significant across sensitivity analyses (RRs=4.9 to 14.0; p=0.02 to p<0.001 at 3 months; RRs=3.0 to 14.0; p=0.01 to p<0.001 at 6 months). VU reported a greater reduction in enjoyment of vaping by the end of the varenicline use period (F=4.1, p=0.04) and recorded a significantly greater reduction in nicotine intake than VN at 3 months (F=13.9, p<0.001) and 6 months (F=26.5, p<0.001).ConclusionVarenicline offered to dual users is likely to promote successful abstinence from both smoking and vaping, although a randomised trial is needed to confirm this. Among dual users who want to stop smoking, there seems to be a high level of interest in smoking-cessation treatments.