NCT02561754

Weight Management for Adolescents With IDD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 13 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

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

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

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	Conventional Diet (CD)	CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet.
BEHAVIORAL	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.
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.
OTHER	iPad with FaceTime	TECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field.

Timeline

• Start date: 2015-03-01
• Primary completion: 2020-05-12
• Completion: 2021-05-05
• First posted: 2015-09-28
• Last updated: 2023-02-10
• Results posted: 2023-02-10

Locations

2 sites across 1 country: United States