Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children

描述(由申请人提供)：我们提出了一项双臂平行分组随机对照试验，以测试在标准的以家庭为基础的团体行为干预中增加创新的环境策略以降低肥胖儿童体重消耗的有效性。自20世纪60年代以来，为了减肥而改变饮食行为的大多数行为干预主要集中在对食物选择和摄入量的自我控制上。最近，研究人员开始识别可能影响摄入量的环境因素，而不需要有意识的、认知的自我控制。总共160名8-15岁肥胖儿童(体重指数第95百分位数)将被随机分配到这两种情况下。所有儿童将与他们的父母(S)/监护人(S)一起参加为期六个月的标准的、每周一次的、以家庭为基础的团体行为体重控制计划。此外，被随机分配到环境策略(ES)干预条件的家庭将接受三种似乎有希望控制肥胖儿童体重的环境干预措施：(1)用又高又细的小容量玻璃杯取代短宽大容量玻璃杯；(2)用较小直径和体积的盘子、碗及餐具取代较大直径和体积的盘子、碗及餐具；(3)避免边看电视边吃东西和其他屏幕媒体。测量将在基线、6个月(行为治疗结束)和18个月(治疗计划结束后一年)收集。体重指数(BMI)是主要的结果衡量标准。初步结果分析将使用随机回归模型比较治疗组和对照组在整个18个月的随访期内体重指数的个体变化轨迹。这项研究有80%的能力来检测临床上有意义的中等效应大小(Cohen‘s d=0.5)或更大的组间差异。基本假设：与只接受标准的基于家庭的团体行为体重控制计划的儿童(控制组)相比，随机接受环境策略干预加上标准的基于家庭的团体行为体重控制计划的儿童(治疗组)在18个月内将显著减少他们的体重增加(BMI)。第二个假设：与对照组相比，在6个月的时间里，治疗组的儿童将显著降低他们的BMI，并在6个月和18个月的时间里显著降低他们的腰围、三头肌皮皱厚度、收缩和舒张压、静息心率、吃电视、每天饮食能量摄入、空腹总胆固醇、低密度脂蛋白-胆固醇、甘油三酯和胰岛素、体重担忧和抑郁症状，并显著提高他们的高密度脂蛋白-胆固醇自尊和学习成绩。

DESCRIPTION (provided by applicant): We propose a 2-arm, parallel group, randomized controlled trial to test the efficacy of adding innovative environmental strategies to reduce energy consumption to a standard family-based, group behavioral intervention for weight control in obese children. Since the 1960's, most behavioral interventions to change eating behavior for weight loss have primarily focused on self-control over food choices and amount of consumption. Recently, researchers have started to identify environmental factors that may influence intake without requiring conscious, cognitive self-control. A total of 160 8-15 year old obese children (BMI e 95th percentile) will be randomized to the two conditions. All children will participate with their parent(s)/guardian(s) in a standard six-month, weekly, family-based, group, behavioral weight control program. In addition, families randomized to the environmental strategies (ES) intervention condition will receive three environmental interventions that appear promising for purposes of weight control in obese children: (1) replacing short and wide and large volume glasses with tall and thin and small volume glasses, (2) replacing larger diameter and volume plates and bowls and utensils with smaller diameter and volume plates, bowls and utensils, and (3) eliminating eating while watching television and other screen media. Measures will be collected at baseline, 6 months (end of the behavioral treatment), and 18 months after baseline (one year after the end of the treatment program). Body Mass Index (BMI) is the primary outcome measure. The primary outcome analysis will compare individual trajectories of change in BMI in the treatment and control groups over the full 18-month follow-up, using random regression models. The study has e 80% power to detect a clinically-significant medium effect size (Cohen's d = 0.5) or greater difference between groups. Primary hypothesis: Children randomized to receive the environmental strategies intervention plus the standard family-based, group behavioral weight control program (the Treatment group), will significantly reduce their weight gain (BMI) over 18-months compared to children randomized to receive only the standard family-based, group behavioral weight control program (the Control group). Secondary hypotheses: Compared to Controls, children in the Treatment group will significantly reduce their BMI over 6-months and reduce their waist circumference, triceps skinfold thickness, systolic and diastolic blood pressures, resting heart rate, meals eaten with TV, daily dietary energy intake, fasting total cholesterol, LDL-cholesterol, triglycerides and insulin, weight concerns and depressive symptoms, and significantly increase their HDL-cholesterol self-esteem, and school performance, over 6- and 18-months.