Clinical trial NCT03291509: Remote Delivery of Weight Management for Adults With IDD
Official title: Remote Delivery of Weight Management for Adults With Intellectual and Developmental Disabilities (IDD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: weight loss
weight management
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-09-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Change in Weight (kg)
timeFrame: Change from Baseline to Month 6
Secondary outcomes:
measure: Change in Weight (kg)
timeFrame: Change from Baseline to Month 24
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Joseph Donnelly, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kansas Medical Center
name: Lauren T Ptomey, PhD, RD, LD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ptomey LT, Washburn RA, Mayo MS, Greene JL, Lee RH, Szabo-Reed AN, Honas JJ, Sherman JR, Donnelly JE. Remote delivery of weight management for adults with intellectual and developmental disabilities: Rationale and design for a 24 month randomized trial. Contemp Clin Trials. 2018 Oct;73:16-26. doi: 10.1016/j.cct.2018.08.010. Epub 2018 Aug 24.