Weight Management for Adolescents With IDD

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2021-05-05

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Face-To-Face/CD

Delivery: Face-to-face Diet: Conventional diet

Group Type ACTIVE_COMPARATOR

Conventional Diet (CD)

Intervention Type DIETARY_SUPPLEMENT

CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet.

Face-to-face (FTF)

Intervention Type BEHAVIORAL

FTF will meet with a health educator in person and will track progress using pen and paper records for both physical activity and diet.

Technology delivery/CD

Delivery: Technology Diet: Conventional diet

Group Type EXPERIMENTAL

Conventional Diet (CD)

Intervention Type DIETARY_SUPPLEMENT

CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet.

Technology (TECH)

Intervention Type BEHAVIORAL

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.

iPad with FaceTime

Intervention Type OTHER

TECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field.

Technology delivery/eSLD

Delivery: Technology Diet: enhanced Stop Light Diet

Group Type EXPERIMENTAL

Enhanced Stop Light Diet (eSLD)

Intervention Type DIETARY_SUPPLEMENT

eSDL includes reduced energy portion controlled meals for 6 months, encouraged consumption of lower energy shakes and 35 fruits and vegetables per week.

Technology (TECH)

Intervention Type BEHAVIORAL

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.

iPad with FaceTime

Intervention Type OTHER

TECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field.

Interventions

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Enhanced Stop Light Diet (eSLD)

eSDL includes reduced energy portion controlled meals for 6 months, encouraged consumption of lower energy shakes and 35 fruits and vegetables per week.

Intervention Type DIETARY_SUPPLEMENT

Conventional Diet (CD)

CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet.

Intervention Type DIETARY_SUPPLEMENT

Face-to-face (FTF)

FTF will meet with a health educator in person and will track progress using pen and paper records for both physical activity and diet.

Intervention Type BEHAVIORAL

Technology (TECH)

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.

Intervention Type BEHAVIORAL

iPad with FaceTime

TECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field.

Intervention Type OTHER

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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No