Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children

描述（由申请人提供）：我们提出了一个2臂，平行组，随机对照试验，以测试添加创新的环境策略，以减少能源消耗的标准家庭为基础的，肥胖儿童的体重控制组行为干预的有效性。自20世纪60年代以来，大多数改变饮食行为以减肥的行为干预主要集中在对食物选择和消费量的自我控制上。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，认知的自我控制。 将总共160名8-15岁肥胖儿童（BMI e第95百分位数）随机分配至两种情况。所有儿童都将与父母/监护人一起参加标准的为期六个月、每周一次、以家庭为基础的团体行为体重控制计划。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）用高瘦小体积的玻璃杯代替短宽大体积的玻璃杯;（2）用直径小体积小的盘碗器皿代替直径大体积大的盘碗器皿;以及（3）避免在看电视和其他屏幕媒体时进食。将在基线、6个月（行为治疗结束）和基线后18个月（治疗计划结束后1年）收集测量结果。体重指数（BMI）是主要的结果指标。主要结局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。该研究具有80%的把握度来检测组间临床显著的中等效应量（Cohen d = 0.5）或更大的差异。 主要假设：随机接受环境策略干预加上标准的基于家庭的群体行为体重控制计划（治疗组）的儿童与随机接受仅基于家庭的群体行为体重控制计划（对照组）的儿童相比，在18个月内体重增加（BMI）显著减少。 次要假设：与对照组相比，治疗组中的儿童将在6个月内显著降低他们的BMI，并降低他们的腰围、三头肌皮褶厚度、收缩压和舒张压、静息心率、与电视一起进食的食物、每日膳食能量摄入、空腹总胆固醇、LDL-胆固醇、甘油三酯和胰岛素、体重问题和抑郁症状，并显著增加他们的HDL-胆固醇自尊，以及在学校的表现。 公共卫生相关性：相关性：肥胖儿童需要有效的体重控制方法。不需要有意识、认知自我控制的减少食物消费的环境策略是一种创新和有前途的方法。如果有效，临床和公共卫生意义将是巨大的，为解决肥胖流行病提供了一个新的范例。

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.