Extended and standard duration weight-loss programme referrals for adults in primary care (WRAP): a randomised controlled trial.
Extended and standard duration weight-loss programme referrals for adults in primary care (WRAP): a randomised controlled trial.
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DOI：
10.1016/s0140-6736(17)30647-5
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发表时间：
2017-06-03
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通讯作者：
Jebb SA
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作者：
Ahern AL;Wheeler GM;Aveyard P;Boyland EJ;Halford JCG;Mander AP;Woolston J;Thomson AM;Tsiountsioura M;Cole D;Mead BR;Irvine L;Turner D;Suhrcke M;Pimpin L;Retat L;Jaccard A;Webber L;Cohn SR;Jebb SA
有证据表明，初级保健转诊至开放团体行为计划是治疗肥胖的有效策略，但关于最佳干预持续时间的证据很少。我们的目的是确定转诊至开放团体体重管理计划的 52 周是否能实现更大的体重减轻和一系列健康结果的改善，并且比目前的 12 周转诊实践更具成本效益。在这项非盲、平行组、随机对照试验中，我们从英格兰 23 个初级保健机构招募了年龄在 18 岁或以上、体重指数 (BMI) 为 28 kg/m2 或更高的参与者。参与者被随机分配（2:5:5）接受简短建议和自助材料、为期 12 周的体重管理计划（慧俪轻体）或为期 52 周的相同体重管理计划。我们对参与者进行了两年多的跟踪调查。主要结果是随访 1 年时的体重，根据意向治疗原则使用混合效应模型进行分析，并根据中心体重和基线体重进行调整。在分层封闭测试程序中，我们比较了具有简短干预的组合行为计划组，然后比较了 12 周计划和 52 周计划。我们使用个人数据进行了试验内成本效益分析，并使用微观模拟对 25 年时间范围内的结果进行了建模。本研究已在当前对照试验中注册，编号 ISRCTN82857232。 2012年10月18日至2014年2月10日期间，我们招募了1269名参与者。 1267 名符合条件的参与者被随机分配到简短干预组 (n=211)、12 周计划 (n=528) 和 52 周计划 (n=528)。为期 12 周的计划中的两名参与者在随机分组后不久被发现不符合资格，因此被排除在分析之外。 1267 名参与者中有 823 名 (65%) 在 1 年完成了评估，856 名 (68%) 参与者在 2 年完成了评估。所有符合条件的参与者都包含在分析中。第 1 年时，各组的平均体重变化为 -3·26 公斤（短暂干预）、-4·75 公斤（12 周计划）和 -6·76 公斤（52 周计划）。行为计划的参与者比短暂干预的参与者减轻了更多体重（调整后的差异-2·71 kg，95% CI -3·86至-1·55；p<0·0001）。 52 周计划比 12 周计划更有效（-2·14 kg，-3·05 至 -1·22；p<0·0001）。 2 年时组间差异仍然显着。没有报告与干预相关的不良事件。两年多以来，52 周计划的增量成本效益比（ICER；与短暂干预相比）为每公斤损失 159 英镑，12 周计划每公斤损失 91 英镑。在基线后 25 年内进行建模，与短暂干预相比，12 周计划的 ICER 占主导地位。与短暂干预（每个质量调整生命年 [QALY] 2394 英镑）和 12 周计划（每个 QALY 3804 英镑）相比，52 周计划的 ICER 具有成本效益。对于超重或肥胖的成年人来说，推荐参加这种开放团体行为减肥计划至少 12 周比简短的建议和自助材料更有效。 52 周的计划比 12 周的计划能带来更大的减肥效果和其他临床益处，尽管成本更高，但模型表明，从长远来看，52 周的计划具有成本效益。国家预防研究计划、慧俪轻体国际（作为英国医学研究理事会工业合作奖的一部分）。
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. 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. 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). 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. National Prevention Research Initiative, Weight Watchers International (as part of an UK Medical Research Council Industrial Collaboration Award).