Weight Management for Adolescents With IDD

NCT02561754 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-02-10

Study results available
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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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02561754 on ClinicalTrials.gov