N/A
N=110
Weight Management for Adolescents With IDD
Developmental Disabilities · Weight Loss · Body Weight · Down Syndrome · Body Weight Changes
Bottom Line
View on ClinicalTrials.gov: NCT02561754 ↗Enrolled (actual)
110
Serious AEs
0.9%
Results posted
Feb 2023
Primary outcome: Primary: Weight Change at 6 Months — -0.3; -1.8; -5.0 kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enhanced Stop Light Diet (eSLD) (Dietary_supplement); Conventional Diet (CD) (Dietary_supplement); Face-to-face (FTF) (Behavioral); Technology (TECH) (Behavioral); iPad with FaceTime (Other)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- University of Kansas Medical Center
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Change at 6 Months |
-0.3; -1.8; -5.0 | — |
| SECONDARY Weight Change Across 18 Months |
1.4; -0.2; -2.2 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02561754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.