N/A
Completed N=120
Remote Delivery of Weight Management for Adults With IDD
Source: ClinicalTrials.gov NCT03291509 ↗Enrolled (actual)
120
Serious AEs
1.7%
Results posted
Mar 2023
Primary outcomePrimary: Change in Weight (kg) — -2.1; -4.9 kg
Summary
The purpose of this study is to compare different weight loss programs in people with IDD to see which program works better.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Weight (kg) |
-2.3; -4.5 | — |
| SECONDARY Change in Weight (kg) |
-2.3; -4.5 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of mild to moderate IDD as determined by a Community Service Provider operating in Kansas under the auspices of a Community Developmental Disability Organization (CDDO). Participants will be judged competent to provide informed consent by their CDDO, or will have a guardian with power of attorney.
- Ability to provide assent, regardless of guardian consent.
- BMI of 25 to 45 kg/m2
- 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
- Living at home with a parent/guardian, or in a supported living environment with a caregiver who assists with food shopping, meal planning, and meal preparation and agrees to serve as a study partner
- No plans to relocate outside the study area over the next 24 months
- Internet access in the home
Exclusion Criteria
- Unable to participate in moderate-to-vigorous physical activity (MVPA)
- Insulin dependent diabetes
- Participation in a weight management program involving diet and physical activity in the past 6 months
- Serious food allergies, consuming special diets (vegetarian, Atkins etc.), aversion to common foods (e.g., unwilling to consume dairy products, vegetables), diagnosis of Prader-Willi Syndrome
- Pregnancy during the previous 6 months, currently lactating or planned pregnancy in the following 24 months.
- Serious medical risk, e.g., cancer, recent heart attack, stroke, angioplasty
- Unwilling to be randomized.
Data sourced from ClinicalTrials.gov (NCT03291509). 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. Informational only — not medical advice.