Remote Delivery of Weight Management for Adults With IDD

University of Kansas

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Video Conference Meetings; Behavioral: Physical Activity; Behavioral: Enhanced Stop Light Diet; Behavioral: In-person Meetings

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03291509

STUDY00140653

R01DK114121-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

In-person Group

Active Comparator group

Description:

Participants randomized to this group will have a health educator to their house for in-person meetings. Participants will use paper forms to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week.

Treatment:

Behavioral: In-person Meetings

Behavioral: Enhanced Stop Light Diet

Behavioral: Physical Activity

Computer Group

Experimental group

Description:

Participants randomized to this group will use an iPad to talk to the health educator via video conference meetings. Participants will use the iPad to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week.

Treatment:

Behavioral: Video Conference Meetings

Behavioral: Enhanced Stop Light Diet

Behavioral: Physical Activity