Weight Loss and Maintenance for Individuals With Intellectual Developmental Disabilities (IDD)

Joseph Donnelly

Status: Completed

Conditions: Weight Loss

Treatments: Dietary Supplement: Recommended Care Diet; Dietary Supplement: Modified Stop Light Diet (SLDm)

Study type: Interventional

Funder types: Other

Identifiers

NCT01724905

18808

Details and patient eligibility

About

Individuals with intellectual developmental disabilities (IDD) have obesity rates that exceed those in the general population, consume energy dense diets, and perform very little physical activity (PA). Overweight and obesity are independent risk factors for chronic disease such as cancer, diabetes, hypertension, and cardiovascular disease in both the general population and those with IDD.

The investigators modified the Stop Light Diet (SLDm) to include reduced energy pre-packaged meals (PM) for 6 months, encouraged consumption of low energy shakes and 35 fruits and vegetables (F/V) per week. The investigators will compare participants who use the SLDm with participants who use a reduced energy and fat diet with meal plans, based off of the current American Dietetic Association recommended car for weight reduction plan.

Enrollment: 151 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of mile to moderate IDD as determined by a Community Service Provider operating in Kansas under the auspices of a Community Developmental Disability Organization (CDDO)
• Able to understand and give informed consent
• If there is a guardian with power of attorney, both the guardian and participant must give informed consent
• Participants must live in a supported living condition either at home or with no more than 1-4 residents and have a care giver (ie. parent, staff) who assists with food shopping, meal planning, and meal preparation
• Overweight or obese determined by a BMI > 25 kg/m2
• Able to walk
• Clearance provided from physician
• Able to communicate preferences

Exclusion criteria

• Uncontrolled hypertension
• Severe heart disease
• Cancer diagnosis
• Positive for HIV

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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151 participants in 2 patient groups

Modified Stop Light Diet

Experimental group

Treatment:

Dietary Supplement: Modified Stop Light Diet (SLDm)

Recommended Care for Weight Reduction

Active Comparator group

Treatment:

Dietary Supplement: Recommended Care Diet