CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 110 enrolled
Drug / intervention
Enhanced Stop Light Diet (eSLD) +4 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02561754
NCT02561754N/ACompleted
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Weight Management for Adolescents With IDD

University of Kansas Medical Center·interventional·Posted Sep 28, 2015·Updated Feb 10, 2023

In Brief

A clinical study evaluating Enhanced Stop Light Diet (eSLD), Conventional Diet (CD), and 3 other interventions for Developmental Disabilities and 5 related conditions. Completed, enrolled 110 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDevelopmental Disabilities, Weight Loss, Body Weight, Down Syndrome, Body Weight Changes, Intellectual Disability
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 28, 2015
Enrollment StartMar 1, 2015
Primary CompletionMay 12, 2020
Study CompletionMay 5, 2021
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 10.8 years ago

Interventions

Enhanced Stop Light Diet (eSLD)dietary

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

Conventional Diet (CD)dietary

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

Face-to-face (FTF)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 (TECH)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 FaceTimeother

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