Remote Delivery of Weight Management for Adults With IDD

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT03291509
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

The purpose of this study is to compare different weight loss programs in people with IDD to see which program works better.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-19
• Study First Submitted QC: 2017-09-19
• Study First Posted: 2017-09-25
• Study Start: 2018-02-21
• Primary Completion: 2021-03-16
• Study Completion: 2022-08-14
• Status Verified: 2023-02
• Results First Submitted: 2023-02-07
• Results First Submitted QC: 2023-02-07
• Last Update Submitted: 2023-02-07
• Results First Posted: 2023-03-07
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Weight (kg)	Change from Baseline to Month 6	Change in weight (kg) from baseline to 6 months

Secondary Outcome Measures

Name	Time	Method
Change in Weight (kg)	Change from Baseline to Month 24	Change in weight across the 24 month study

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States