Wilfley Denise E, Saelens Brian E, Stein Richard I, Best John R, Kolko Rachel P, Schechtman Kenneth B, Wallendorf Michael, Welch R Robinson, Perri Michael G, Epstein Leonard H
Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri.
Department of Pediatrics, University of Washington, Seattle.
JAMA Pediatr. 2017 Dec 1;171(12):1151-1159. doi: 10.1001/jamapediatrics.2017.2960.
Elucidation of optimal dosing and treatment content is critical for health care providers, payers, and policy makers, as well as mechanisms of change to inform intervention delivery and training initiatives for childhood obesity.
To evaluate effects, following a 4-month family-based behavioral weight loss treatment (FBT), of 2 doses (HIGH or LOW) of a weight-control intervention (enhanced social facilitation maintenance [SFM+]) vs a weight-control education condition (CONTROL; matched for dose with LOW), on child anthropometrics, and to explore putative mediators of weight loss outcomes.
DESIGN, SETTING, AND PARTICIPANTS: For this parallel-group randomized clinical trial conducted at 2 US academic medical centers from December 2009 to March 2013, 172 parent-child dyads completed FBT and were then randomized to 8 months of SFM+ (HIGH, n = 59; LOW, n = 56) or CONTROL (n = 57). Children (aged 7-11 years) with overweight and obesity (body mass index [BMI; calculated as weight in kilograms divided by height in meters squared] ≥85th percentile) with at least 1 parent with overweight and obesity (BMI ≥25) were recruited.
HIGH SFM+ vs LOW SFM+ (CONTROL matched the dose of LOW).
Intention-to-treat analysis using mixed-effects models estimated change in child percentage overweight (percentage above the median BMI for a child's age and sex) for the FBT period (0-4 months) and the SFM+ period (4-12 months), and proportion of children achieving a clinically significant change in percentage overweight (≥9-unit decrease; months 0-12). Theory-based outcome mediators were also evaluated.
This study recruited 172 parent-child dyads (mean [SD] age: parents 42.3 [6.4] years; children, 9.4 [1.3] years). The omnibus treatment × time interaction for child percentage overweight was significant (F8, 618.9 = 2.89; P = .004). Planned pairwise comparisons revealed that from months 4 to 12, LOW had better outcomes than CONTROL (difference, -3.34; 95% CI, -6.21 to -0.47; d = -0.40; P = .02). HIGH had better outcomes than LOW (difference, -3.37; 95% CI, -6.15 to -0.59; d = -0.38; P = .02) and CONTROL (difference, -6.71; 95% CI, -9.57 to -3.84; d = -0.77; P < .001). A greater proportion of children in HIGH (45 [82%]) vs LOW (34 [64%]) (difference, 18.00; 95% CI, 1.00-34.00; P = .03; number needed to treat = 5.56) and CONTROL (25 [48%]) (difference, 34.00; 95% CI, 16.00-51.00; P < .001; number needed to treat = 2.94) had clinically significant percentage overweight reductions. Food and activity monitoring and goal setting mediated the effect of LOW vs CONTROL (50%). Monitoring and goal setting, family and home environment, and healthy behaviors with peers mediated the effect of HIGH vs CONTROL (25%-42%).
Following FBT, specialized intervention content (SFM+) enhanced children's weight outcomes and outperformed a credible control condition, with high dose delivery yielding the best outcomes. Sustained monitoring and goal setting, support from the family and home environment, and healthy peer interactions explained outcome differences, highlighting key treatment targets.
clinicaltrials.gov Identifier: NCT00759746.
阐明最佳剂量和治疗内容对医疗服务提供者、支付方和政策制定者而言至关重要，同时对于为儿童肥胖症干预实施和培训计划提供依据的改变机制也很关键。
评估在为期4个月的家庭行为性体重减轻治疗（FBT）后，两种剂量（高剂量或低剂量）的体重控制干预措施（强化社会促进维持 [SFM+]）与体重控制教育对照条件（对照组；剂量与低剂量组匹配）对儿童人体测量指标的影响，并探讨体重减轻结果的假定中介因素。
设计、地点和参与者：在2009年12月至2013年3月于美国2家学术医疗中心进行的这项平行组随机临床试验中，172对亲子完成了FBT，随后被随机分配至8个月的SFM+组（高剂量组，n = 59；低剂量组，n = 56）或对照组（n = 57）。招募了超重和肥胖儿童（年龄7至11岁，体重指数 [BMI；计算方法为千克体重除以米平方身高] ≥第85百分位数）且至少有1名超重和肥胖父母（BMI≥25）的亲子对。
高剂量SFM+组与低剂量SFM+组（对照组剂量与低剂量组匹配）。
使用混合效应模型进行意向性分析，估计FBT阶段（0至4个月）和SFM+阶段（4至12个月）儿童超重百分比（高于儿童年龄和性别的BMI中位数的百分比）的变化，以及超重百分比实现临床显著变化（降低≥9个单位；0至12个月）的儿童比例。还评估了基于理论的结局中介因素。
本研究招募了172对亲子对（平均 [标准差] 年龄：父母42.3 [6.4] 岁；儿童，9.4 [1.3] 岁）。儿童超重百分比的总体治疗×时间交互作用显著（F8, 618.9 = 2.89；P = .004）。计划的成对比较显示，从第4个月至第12个月，低剂量组的结局优于对照组（差异，-3.34；95% 置信区间，-6.21至-0.47；d = -0.40；P = .02）。高剂量组的结局优于低剂量组（差异，-3.37；95% 置信区间，-6.15至-0.59；d = -0.38；P = .02）和对照组（差异，-6.71；95% 置信区间，-9.57至-3.84；d = -0.77；P < .001）。高剂量组中实现超重百分比临床显著降低的儿童比例更高（45 [82%]），高于低剂量组（34 [64%]）（差异，18.00；95% 置信区间，1.00 - 34.00；P = .03；需治疗人数 =
5.56）和对照组（25 [48%]）（差异，34.00；95% 置信区间，16.00 - 51.00；P < .001；需治疗人数 = 2.94）。食物和活动监测以及目标设定介导了低剂量组与对照组相比的效果（50%）。监测和目标设定、家庭和家庭环境以及与同伴的健康行为介导了高剂量组与对照组相比的效果（25% - 42%）。
FBT后，专门的干预内容（SFM+）改善了儿童的体重结局，且优于可信的对照条件，高剂量实施产生了最佳结局。持续的监测和目标设定以及家庭和家庭环境的支持以及健康的同伴互动解释了结局差异，突出了关键治疗靶点。
clinicaltrials.gov标识符：NCT00759746。
