Weight Loss and Maintenance for Individuals With Intellectual Developmental Disabilities (IDD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 2
- 主要终点
- Weight loss between experimental diet (SLDm) and recommended care diet (RC)
研究概览
简要总结
Individuals with intellectual developmental disabilities (IDD) have obesity rates that exceed those in the general population, consume energy dense diets, and perform very little physical activity (PA). Overweight and obesity are independent risk factors for chronic disease such as cancer, diabetes, hypertension, and cardiovascular disease in both the general population and those with IDD.
The investigators modified the Stop Light Diet (SLDm) to include reduced energy pre-packaged meals (PM) for 6 months, encouraged consumption of low energy shakes and 35 fruits and vegetables (F/V) per week. The investigators will compare participants who use the SLDm with participants who use a reduced energy and fat diet with meal plans, based off of the current American Dietetic Association recommended car for weight reduction plan.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of mile to moderate IDD as determined by a Community Service Provider operating in Kansas under the auspices of a Community Developmental Disability Organization (CDDO)
- •Able to understand and give informed consent
- •If there is a guardian with power of attorney, both the guardian and participant must give informed consent
- •Participants must live in a supported living condition either at home or with no more than 1-4 residents and have a care giver (ie. parent, staff) who assists with food shopping, meal planning, and meal preparation
- •Overweight or obese determined by a BMI > 25 kg/m2
- •Able to walk
- •Clearance provided from physician
- •Able to communicate preferences
排除标准
- •Uncontrolled hypertension
- •Severe heart disease
- •Cancer diagnosis
- •Positive for HIV
结局指标
主要结局
Weight loss between experimental diet (SLDm) and recommended care diet (RC)
时间窗: Change from Baseline in Weight at 18 months
The experimental diet is the Stop Light Diet modified (SLDm) and includes PM, 35 F/V per week, and low energy shakes. The Investigators will compare this to the RC diet that uses traditional meal plans and includes 35 F/V per week. Weight to be measured following an overnight fast of approximately 12 hours. Weight will be measured in kg. Each person will be weighed in a hospital gown between 8 and 10 am, using a calibrated scale to the nearest 0.1kg.
次要结局
- Comparison of chronic disease factors - Blood Pressure(Change from Baseline in Blood Pressure at 18 months)
- Comparison of chronic disease factors - Glucose(Change from Baseline in Glucose at 18 months)
- Comparison of chronic disease factors - HDL(Change from Baseline in HDL-cholesterol Pressure at 18 months)
- Comparison of chronic disease factors - LDL(Change from Baseline in LDL-cholesterol Pressure at 18 months)
- Comparison of chronic disease factors - Insulin(Change from Baseline in Insulin Pressure at 18 months)
研究者
Joseph Donnelly
Professor
University of Kansas Medical Center