ImportanceAdolescent severe obesity is usually not effectively treated with traditional lifestyle modification therapy. Meal replacement therapy (MRT) shows short-term efficacy for body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) reduction in adolescents, and financial incentives (FIs) may be an appropriate adjunct intervention to enhance long-term efficacy.ObjectiveTo evaluate the effect of MRT plus FIs vs MRT alone on BMI, body fat, and cardiometabolic risk factors in adolescents with severe obesity.Design, Setting, and ParticipantsThis was a randomized clinical trial of MRT plus FIs vs MRT alone at a large academic health center in the Midwest conducted from 2018 to 2022. Participants were adolescents (ages 13-17 y) with severe obesity (≥120% of the 95th BMI percentile based on sex and age or ≥35 BMI, whichever was lower) who were unaware of the FI component of the trial until they were randomized to MRT plus FIs or until the end of the trial. Study staff members collecting clinical measures were blinded to treatment condition. Data were analyzed from March 2022 to February 2024.InterventionsMRT included provision of preportioned, calorie-controlled meals (~1200 kcals/d). In the MRT plus FI group, incentives were provided based on reduction in body weight from baseline.Main Outcomes and MeasuresThe primary end point was mean BMI percentage change from randomization to 52 weeks. Secondary end points included total body fat and cardiometabolic risk factors: blood pressure, triglyceride to high-density lipoprotein ratio, heart rate variability, and arterial stiffness. Cost-effectiveness was additionally evaluated. Safety was assessed through monthly adverse event monitoring and frequent assessment of unhealthy weight-control behaviors.ResultsAmong 126 adolescents with severe obesity (73 female [57.9%]; mean [SD] age, 15.3 [1.2] years), 63 participants received MRT plus FIs and 63 participants received only MRT. At 52 weeks, the mean BMI reduction was greater by −5.9 percentage points (95% CI, −9.9 to −1.9 percentage points; P = .004) in the MRT plus FI compared with the MRT group. The MRT plus FI group had a greater reduction in mean total body fat mass by −4.8 kg (95% CI, −9.1 to −0.6 kg; P = .03) and was cost-effective (incremental cost-effectiveness ratio, $39 178 per quality-adjusted life year) compared with MRT alone. There were no significant differences in cardiometabolic risk factors or unhealthy weight-control behaviors between groups.Conclusions and RelevanceIn this study, adding FIs to MRT resulted in greater reductions in BMI and total body fat in adolescents with severe obesity without increased unhealthy weight-control behaviors. FIs were cost-effective and possibly promoted adherence to health behaviors.Trial RegistrationClinicalTrials.gov Identifier: NCT03137433

中文翻译：

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严重肥胖青少年的经济激励和治疗结果


重要性 传统的生活方式改变疗法通常无法有效治疗青少年严重肥胖。膳食替代疗法（MRT）显示出减少青少年体重指数（BMI；计算方法为体重（千克）除以身高（米的平方））的短期疗效，而经济激励（FI）可能是一种适当的辅助干预措施，可增强长期健康状况。长期疗效。目的评估 MRT 加 FI 与单独 MRT 对重度肥胖青少年的 BMI、体脂和心脏代谢危险因素的影响。设计、设置和参与者这是一项 MRT 加 FI 与单独 MRT 的随机临床试验，试验时间为中西部大型学术健康中心于 2018 年至 2022 年进行了一项研究。参与者是患有严重肥胖症（基于性别和年龄的 BMI 第 95 个百分位数≥120% 或 ≥ 35 BMI，以较低者为准）的青少年（13-17 岁），在被随机分配到 MRT 加 FI 组或试验结束之前，他们并不知道试验的 FI 部分。收集临床指标的研究人员对治疗情况不知情。数据分析时间为 2022 年 3 月至 2024 年 2 月。干预措施 MRT 包括提供预先分配的热量控制膳食（约 1200 kcals/d）。在 MRT 加 FI 组中，根据体重较基线的减少情况提供激励。主要结果和措施主要终点是从随机到 52 周的平均 BMI 百分比变化。次要终点包括全身脂肪和心脏代谢危险因素：血压、甘油三酯与高密度脂蛋白的比率、心率变异性和动脉僵硬度。另外还评估了成本效益。 通过每月不良事件监测和对不健康体重控制行为的频繁评估来评估安全性。结果在 126 名严重肥胖青少年（73 名女性 [57.9%]；平均 [SD] 年龄，15.3 [1.2] 岁）中，63 名参与者接受了 MRT 加FI 和 63 名参与者仅接受了 MRT。 52 周时，平均 BMI 降低幅度更大 -5.9 个百分点（95% CI，-9.9 至 -1.9 个百分点；磷= .004) MRT 加 FI 与 MRT 组相比。 MRT 加 FI 组的平均全身脂肪量显着降低 -4.8 kg（95% CI，-9.1 至 -0.6 kg；磷= .03），并且与单独 MRT 相比具有成本效益（增量成本效益比，每个质量调整生命年 39 178 美元）。各组之间的心脏代谢危险因素或不健康的体重控制行为没有显着差异。结论和相关性在这项研究中，在 MRT 中添加 FI 可以使重度肥胖青少年的 BMI 和总体脂肪更大程度地降低，同时不增加不健康的体重控制行为。 FI 具有成本效益，并且可能促进对健康行为的遵守。试验注册临床试验。政府标识符： NCT03137433