Weight Loss Clinical Trial
— IDDAdolOfficial title:
Weight Management for Adolescents With IDD
Verified date | February 2023 |
Source | University of Kansas Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | May 5, 2021 |
Est. primary completion date | May 12, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 21 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | Energy Balance Lab, The University of Kansas | Lawrence | Kansas |
Lead Sponsor | Collaborator |
---|---|
University of Kansas Medical Center | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight Change at 6 Months | Participants will be weighed in shorts and a t-shirt , on a calibrated scale to the nearest 0.1 kg. | Change in weight from baseline to 6 months | |
Secondary | Weight Change Across 18 Months | Participants will be weighed in shorts and a t-shirt between 7 and 10 AM, in duplicate, on a calibrated scale to the nearest 0.1 kg. | Change in weight from baseline to 18 months |
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