Weight Management for Adolescents With IDD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Weight Change at 6 Months
研究概览
简要总结
The goal of this study is to explore the impact of two different diets (conventional vs. enhanced stop light) and two different delivery systems (face-to-face vs. remote) on weight across 18 months in overweight and obese adolescents with intellectual and developmental disabilities.
详细描述
Rates of obesity and obesity related chronic health conditions are higher in adolescents with Intellectual and Developmental Disabilities (IDD) than those in the general population. Many of the negative health consequences observed in obese adults are already present in obese adolescents with IDD.
This study is a 3 group randomized trial to evaluate the intervention delivery system and type of reduced energy diet. The investigators will randomize 123 overweight/obese adolescents with mild to moderate IDD to one of 3 groups for an 18 month trial (6 month weight loss; 12 month weight maintenance):
group 1) Face-To-Face/CD
group 2) Technology delivery/CD
group 3) Technology delivery/eSLD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 13-21 yrs
- •Mild (IQ of 74-50) or moderate (IQ 40-49) IDD,
- •Of sufficient functional ability to understand directions, communicate preferences (e.g. foods), wants (e.g. more to eat/drink), and needs (e.g. assistance with food preparation) through spoken language.
- •Overweight or obese (BMI ≥ 85th%ile on CDC growth charts, or waist circumference to height ratio > 0.5
- •Living at home with a parent or guardian.
- •Internet access in the home.
- •No plans to relocate outside the study area over the next 18 mos
- •Physician consent for PA and diet.
排除标准
- •Insulin dependent diabetes
- •Participation in a weight management program involving diet and PA in the past 6 mos
- •Eating disorders, serious food allergies, consuming special diets, aversion to common foods,
- •Diagnosis of Prader-Willi Syndrome
- •Currently pregnant, planning on/becoming pregnant during the study.
- •Unable to participate in moderate to vigorous PA.
结局指标
主要结局
Weight Change at 6 Months
时间窗: Change in weight from baseline to 6 months
Participants will be weighed in shorts and a t-shirt , on a calibrated scale to the nearest 0.1 kg.
次要结局
- Weight Change Across 18 Months(Change in weight from baseline to 18 months)