Department of Health Professions, Faculty of Health and Life Sciences RC131, Coventry University, Priory Street, Coventry CV1 5FB, UK.
Trials. 2013 Jun 19;14:182. doi: 10.1186/1745-6215-14-182.
Quitting smokers gain weight. This deters some from trying to stop smoking and may explain the increased incidence of type 2 diabetes after cessation. Dieting when stopping smoking may be counterproductive. Hunger increases cravings for smoking and tackling two behaviours together may undermine quitting success. A meta-analysis of randomized controlled trials (RCTs) showed individualized dietary support may prevent weight gain, although there is insufficient evidence whether it undermines smoking cessation. Commercial weight management providers (CWMPs), such as Slimming World, provide individualized dietary support for National Health Service (NHS) patients; however, there is no evidence that they can prevent cessation-related weight gain.Our objective is to determine whether attending Slimming World from quit date, through referral from NHS Stop Smoking Services, is more effective than usual care at preventing cessation-related weight gain.
This RCT will examine the effectiveness of usual cessation support plus referral to Slimming World compared to usual cessation support alone. Healthy weight, overweight and obese adult smokers attending Stop Smoking Services will be included. The primary outcome is weight change in quitters 12 weeks post-randomization. Multivariable linear regression analysis will compare weight change between trial arms and adjust for known predictors of cessation-related weight gain.We will recruit 320 participants, with 160 participants in each arm. An alpha error rate of 5% and 90% power will detect a 2 kg (SD = 2.5) difference in weight gain at 12 weeks, assuming 20% remain abstinent by then.
This trial will establish whether referral to the 12-week Slimming World programme plus usual care is an effective intervention to prevent cessation-related weight gain. If so, we will seek to establish whether weight control comes at the expense of a successful quit attempt in a further non-inferiority trial.Positive results from both these trials would provide a potential solution to cessation-related weight gain, which could be rolled out across England within Stop Smoking Services to better meet the needs of 0.75 million smokers stopping with NHS support every year.
Current Controlled Trials ISRCTN65705512.
戒烟者会体重增加。这阻止了一些人尝试戒烟，也可能解释了戒烟后 2 型糖尿病发病率的增加。戒烟时节食可能适得其反。饥饿会增加对吸烟的渴望，同时应对两种行为可能会破坏戒烟的成功。一项随机对照试验 (RCT) 的荟萃分析表明，个体化饮食支持可能预防体重增加，尽管没有足够的证据表明它是否会破坏戒烟。商业体重管理提供商 (CWMPs)，如 Slimming World，为国民保健服务 (NHS) 患者提供个体化饮食支持；然而，没有证据表明它们可以预防与戒烟相关的体重增加。我们的目的是确定从戒烟日期开始参加 Slimming World，通过 NHS 戒烟服务转介，是否比单独使用常规护理更能有效预防与戒烟相关的体重增加。
这项 RCT 将研究常规戒烟支持加转介到 Slimming World 与单独常规戒烟支持相比的效果。将纳入健康体重、超重和肥胖的成年吸烟者。主要结局是随机分组后 12 周戒烟者的体重变化。多变量线性回归分析将比较试验臂之间的体重变化，并调整与戒烟相关的体重增加的已知预测因素。我们将招募 320 名参与者，每组 160 名。假设到那时 20%的人仍保持不吸烟，那么 5%的α误差率和 90%的功效将在 12 周时检测到体重增加 2 公斤（SD=2.5）的差异。
这项试验将确定转介到为期 12 周的 Slimming World 计划加常规护理是否是预防与戒烟相关的体重增加的有效干预措施。如果是这样，我们将寻求在进一步的非劣效性试验中确定体重控制是否以成功戒烟尝试为代价。这两项试验的积极结果将为与戒烟相关的体重增加提供潜在的解决方案，可以在英格兰的戒烟服务中推广，以更好地满足每年有 75 万吸烟者在 NHS 支持下戒烟的需求。
当前对照试验 ISRCTN65705512。
