Weight Management for Adolescents With IDD
NCT02561754 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2023-02-10
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.
Conditions
- Developmental Disabilities
- Weight Loss
- Body Weight
- Down Syndrome
- Body Weight Changes
- Intellectual Disability
Interventions
- 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.
Sponsors & Collaborators
-
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
collaborator NIH -
University of Kansas Medical Center
lead OTHER
Principal Investigators
-
Joseph E Donnelly, EdD · University of Kansas Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 13 Years
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-03-31
- Primary Completion
- 2020-05-12
- Completion
- 2021-05-05
Countries
- United States
Study Locations
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