超重人群转介至低能量全代餐治疗（DROPLET）的医生干预：实用随机对照试验。
Doctor Referral of Overweight People to Low Energy total diet replacement Treatment (DROPLET): pragmatic randomised controlled trial.
机构信息
Nuffield Department of Primary Care Health Sciences, University of Oxford, UK
Nuffield Department of Primary Care Health Sciences, University of Oxford, UK.
出版信息
BMJ. 2018 Sep 26;362:k3760. doi: 10.1136/bmj.k3760.
OBJECTIVE
To test the effectiveness and safety of a total diet replacement (TDR) programme for routine treatment of obesity in a primary care setting.
DESIGN
Pragmatic, two arm, parallel group, open label, individually randomised controlled trial.
SETTING
10 primary care practices in Oxfordshire, UK.
PARTICIPANTS
278 adults who were obese and seeking support to lose weight: 138 were assigned to the TDR programme and 140 to usual care. 73% of participants were re-measured at 12 months.
INTERVENTIONS
The TDR programme comprised weekly behavioural support for 12 weeks and monthly support for three months, with formula food products providing 810 kcal/day (3389 kJ/day) as the sole food during the first eight weeks followed by reintroduction of food. Usual care comprised behavioural support for weight loss from a practice nurse and a diet programme with modest energy restriction.
MAIN OUTCOME MEASURES
The primary outcome was weight change at 12 months analysed as intention to treat with mixed effects models. Secondary outcomes included biomarkers of cardiovascular and metabolic risk. Adverse events were recorded.
RESULTS
Participants in the TDR group lost more weight (-10.7 kg) than those in the usual care group (-3.1 kg): adjusted mean difference -7.2 kg (95% confidence interval -9.4 to -4.9 kg). 45% of participants in the TDR group and 15% in the usual care group experienced weight losses of 10% or more. The TDR group showed greater improvements in biomarkers of cardiovascular and metabolic risk than the usual care group. 11% of participants in the TDR group and 12% in the usual care group experienced adverse events of moderate or greater severity.
CONCLUSIONS
Compared with regular weight loss support from a practice nurse, a programme of weekly behavioural support and total diet replacement providing 810 kcal/day seems to be tolerable, and leads to substantially greater weight loss and greater improvements in the risk of cardiometabolic disease.
TRIAL REGISTRATION
International Standard Randomised Controlled Trials No ISRCTN75092026.
目的
在初级保健环境中，测试总饮食替代（TDR）计划常规治疗肥胖的有效性和安全性。
设计
实用、双臂、平行组、开放标签、个体随机对照试验。
地点
英国牛津郡的 10 个初级保健诊所。
参与者
278 名肥胖并寻求减肥支持的成年人：138 名被分配到 TDR 计划，140 名接受常规护理。73%的参与者在 12 个月时重新测量。
干预措施
TDR 计划包括 12 周的每周行为支持和 3 个月的每月支持，前 8 周内使用配方食品产品提供 810 千卡/天（3389 千焦/天）作为唯一食物，然后重新引入食物。常规护理包括由执业护士提供的减肥行为支持和适度能量限制的饮食计划。
主要结果测量
主要结局是 12 个月时的体重变化，采用混合效应模型进行意向治疗分析。次要结局包括心血管和代谢风险的生物标志物。记录不良事件。
结果
TDR 组参与者体重减轻（-10.7 公斤）多于常规护理组（-3.1 公斤）：调整后的平均差异为-7.2 公斤（95%置信区间-9.4 至-4.9 公斤）。TDR 组 45%的参与者和常规护理组 15%的参与者体重减轻 10%或更多。TDR 组的心血管和代谢风险生物标志物改善大于常规护理组。TDR 组 11%的参与者和常规护理组 12%的参与者经历了中度或更严重的不良事件。
结论
与实践护士提供的常规减肥支持相比，每周行为支持和每日提供 810 千卡的总饮食替代计划似乎是可以耐受的，并导致体重显著减轻，心血管代谢疾病风险显著改善。
试验注册
国际标准随机对照试验号 ISRCTN75092026。
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