Remote Delivery of Weight Management for Adults With IDD

Study Overview
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Brief Summary
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The purpose of this study is to compare different weight loss programs in people with IDD to see which program works better.

Official Title
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Remote Delivery of Weight Management for Adults With Intellectual and Developmental Disabilities (IDD)

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Video Conference Meetings
* Behavioral: In-person Meetings
* Behavioral: Enhanced Stop Light Diet
* Behavioral: Physical Activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: In-person Group<br>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. | Behavioral: In-person Meetings<br>* Individual face-to-face (FTF) meetings with a health educator.<br>Behavioral: Enhanced Stop Light Diet<br>* Diet composed of healthy, pre-packaged meals, balance of fruits, vegetables, and low calories snacks, and shakes. Participants and study partners will be trained to use a color coded chart which categorize foods based on the Stop Light system (green, yellow, red) to assist in meal planning, grocery shopping, decisions regarding snack foods, and compliance with the diet in special situations such as eating away from home (restaurants, parties, etc.).<br>* Other names: eSLD;Behavioral: Physical Activity<br>* Participants will be asked to complete a set amount of time of moderate-to-vigorous physical activity each week. Participants in the Computer group will be asked to attend remote exercise sessions 2 times a week.<br>|
| Experimental: Computer Group<br>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. | Behavioral: Video Conference Meetings<br>* Individual video conferencing with a health educator using an iPad.<br>Behavioral: Enhanced Stop Light Diet<br>* Diet composed of healthy, pre-packaged meals, balance of fruits, vegetables, and low calories snacks, and shakes. Participants and study partners will be trained to use a color coded chart which categorize foods based on the Stop Light system (green, yellow, red) to assist in meal planning, grocery shopping, decisions regarding snack foods, and compliance with the diet in special situations such as eating away from home (restaurants, parties, etc.).<br>* Other names: eSLD;Behavioral: Physical Activity<br>* Participants will be asked to complete a set amount of time of moderate-to-vigorous physical activity each week. Participants in the Computer group will be asked to attend remote exercise sessions 2 times a week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight (kg) | Change in weight (kg) from baseline to 6 months | Change from Baseline to Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight (kg) | Change in weight across the 24 month study | Change from Baseline to Month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight loss, weight management