Weight Management for Adolescents With IDD

Study Overview
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Brief Summary
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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.

Detailed Description
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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. All participants will receive a progressive program of physical activity. Participants on the CD diet will be asked to consume a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet. Participants on the eSLD will consume pre-packaged portion controlled meals with the addition of 5 fruits and vegetables per day. FTF will meet with a health educator and will track progress using pen and paper records for both physical activity and diet. TECH groups will receive the intervention using an iPad with the FaceTimeTM application for video meetings with a health educator and will track progress using the Lose it! application for both physical activity and diet.

Official Title
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Weight Management for Adolescents With IDD

Conditions
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Developmental Disabilities, Weight Loss, Body Weight, Down Syndrome, Body Weight Changes, Intellectual Disability

Intervention / Treatment
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* Dietary Supplement: Enhanced Stop Light Diet (eSLD)
* Dietary Supplement: Conventional Diet (CD)
* Behavioral: Face-to-face (FTF)
* Behavioral: Technology (TECH)
* Other: iPad with FaceTime


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 21 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: Face-To-Face/CD<br>Delivery: Face-to-face Diet: Conventional diet | Dietary Supplement: Conventional Diet (CD)<br>* CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet.<br>Behavioral: Face-to-face (FTF)<br>* FTF will meet with a health educator in person and will track progress using pen and paper records for both physical activity and diet.<br>|
| Experimental: Technology delivery/CD<br>Delivery: Technology Diet: Conventional diet | Dietary Supplement: Conventional Diet (CD)<br>* CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet.<br>Behavioral: Technology (TECH)<br>* TECH groups will receive the intervention using an iPad with the FaceTimeTM application for video meetings with a health educator and will track progress using the Lose it! application for both physical activity and diet.<br>Other: iPad with FaceTime<br>* TECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field.<br>|
| Experimental: Technology delivery/eSLD<br>Delivery: Technology Diet: enhanced Stop Light Diet | Dietary Supplement: Enhanced Stop Light Diet (eSLD)<br>* eSDL includes reduced energy portion controlled meals for 6 months, encouraged consumption of lower energy shakes and 35 fruits and vegetables per week.<br>Behavioral: Technology (TECH)<br>* TECH groups will receive the intervention using an iPad with the FaceTimeTM application for video meetings with a health educator and will track progress using the Lose it! application for both physical activity and diet.<br>Other: iPad with FaceTime<br>* TECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Change at 6 Months | Participants will be weighed in shorts and a t-shirt , on a calibrated scale to the nearest 0.1 kg. | Change in weight from baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Change Across 18 Months | Participants will be weighed in shorts and a t-shirt between 7 and 10 AM, in duplicate, on a calibrated scale to the nearest 0.1 kg. | Change in weight from baseline to 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, Obesity, Adolescents, Intellectual and Developmental Disability