Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children

描述（由申请人提供）：我们提出了一项双组、平行组、随机对照试验，以测试在标准的以家庭为基础的群体行为干预中加入创新的环境策略以减少能源消耗对肥胖儿童体重控制的效果。自20世纪60年代以来，大多数为了减肥而改变饮食行为的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，研究人员已经开始确定可能影响摄入量的环境因素，而不需要有意识的认知自我控制。将160名8-15岁肥胖儿童（BMI为95百分位）随机分为两组。所有的孩子都将和他们的父母/监护人一起参加一个标准的六个月、每周一次、以家庭为基础的团体行为体重控制项目。此外，随机分配到环境策略（ES）干预条件的家庭将接受三种环境干预措施，这些干预措施似乎有望控制肥胖儿童的体重：(1)用高、薄、小容量的玻璃杯代替短、宽、大容量的玻璃杯；(2)用小直径、小容量的盘子、碗、器皿代替大直径、大容量的盘子、碗、器皿；(3)杜绝边看电视等屏幕媒体边吃东西。测量将在基线、6个月（行为治疗结束）和基线后18个月（治疗方案结束一年后）收集。身体质量指数（BMI）是主要的结果衡量指标。主要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个月随访期间BMI变化的个体轨迹。该研究有80%的能力检测到组间具有临床意义的中等效应量（Cohen’s d = 0.5）或更大的差异。主要假设：儿童随机接受环境策略干预加上标准的以家庭为基础的群体行为体重控制计划（治疗组），与儿童随机接受标准的以家庭为基础的群体行为体重控制计划（对照组）相比，他们的体重增加（BMI）在18个月内显著降低。二次假设:与对照组相比，治疗组的儿童在6个月内显著降低BMI，腰围、肱三头肌皮襞厚度、收缩压和舒张压、静息心率、看电视吃饭、每日膳食能量摄入、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，并在6个月和18个月内显著提高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. PUBLIC HEALTH RELEVANCE: Relevance: There is a need for effective weight control methods for obese children. Environmental strategies to reduce food consumption that do not require conscious, cognitive self- control are an innovative and promising approach. If effective, the clinical and public health implications would be great, providing a new paradigm to address the obesity epidemic.