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Clinical Trials/NCT03291509
NCT03291509
Completed
Not Applicable

Remote Delivery of Weight Management for Adults With Intellectual and Developmental Disabilities (IDD)

University of Kansas Medical Center1 site in 1 country120 target enrollmentFebruary 21, 2018
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Kansas Medical Center
Enrollment
120
Locations
1
Primary Endpoint
Change in Weight (kg)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
February 21, 2018
End Date
August 14, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Change in Weight (kg)

Time Frame: Change from Baseline to Month 6

Change in weight (kg) from baseline to 6 months

Secondary Outcomes

  • Change in Weight (kg)(Change from Baseline to Month 24)

Study Sites (1)

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