Remote Delivery of Weight Management for Adults With Intellectual and Developmental Disabilities (IDD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Weight (kg)
研究概览
简要总结
The purpose of this study is to compare different weight loss programs in people with IDD to see which program works better.
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 mild to moderate IDD as determined by a Community Service Provider operating in Kansas under the auspices of a Community Developmental Disability Organization (CDDO). Participants will be judged competent to provide informed consent by their CDDO, or will have a guardian with power of attorney.
- •Ability to provide assent, regardless of guardian consent.
- •BMI of 25 to 45 kg/m2
- •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
- •Living at home with a parent/guardian, or in a supported living environment with a caregiver who assists with food shopping, meal planning, and meal preparation and agrees to serve as a study partner
- •No plans to relocate outside the study area over the next 24 months
- •Internet access in the home
排除标准
- •Unable to participate in moderate-to-vigorous physical activity (MVPA)
- •Insulin dependent diabetes
- •Participation in a weight management program involving diet and physical activity in the past 6 months
- •Serious food allergies, consuming special diets (vegetarian, Atkins etc.), aversion to common foods (e.g., unwilling to consume dairy products, vegetables), diagnosis of Prader-Willi Syndrome
- •Pregnancy during the previous 6 months, currently lactating or planned pregnancy in the following 24 months.
- •Serious medical risk, e.g., cancer, recent heart attack, stroke, angioplasty
- •Unwilling to be randomized.
研究组 & 干预措施
In-person Group
Participants randomized to this group will have a health educator to their house for in-person meetings. Participants will use paper forms to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week.
干预措施: In-person Meetings (Behavioral)
In-person Group
Participants randomized to this group will have a health educator to their house for in-person meetings. Participants will use paper forms to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week.
干预措施: Enhanced Stop Light Diet (Behavioral)
In-person Group
Participants randomized to this group will have a health educator to their house for in-person meetings. Participants will use paper forms to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week.
干预措施: Physical Activity (Behavioral)
Computer Group
Participants randomized to this group will use an iPad to talk to the health educator via video conference meetings. Participants will use the iPad to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week.
干预措施: Enhanced Stop Light Diet (Behavioral)
Computer Group
Participants randomized to this group will use an iPad to talk to the health educator via video conference meetings. Participants will use the iPad to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week.
干预措施: Video Conference Meetings (Behavioral)
Computer Group
Participants randomized to this group will use an iPad to talk to the health educator via video conference meetings. Participants will use the iPad to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week.
干预措施: Physical Activity (Behavioral)
结局指标
主要结局
Change in Weight (kg)
时间窗: Change from Baseline to Month 6
Change in weight (kg) from baseline to 6 months
次要结局
- Change in Weight (kg)(Change from Baseline to Month 24)