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

Not Applicable

Completed

• Conditions: Weight Loss

• Registration Number: NCT01724905
• Lead Sponsor: Joseph Donnelly

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-10-01
• Study First Submitted QC: 2012-11-07
• Study First Posted: 2012-11-12
• Primary Completion: 2015-05
• Study Completion: 2015-07
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-10
• Last Update Posted: 2015-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weight loss between experimental diet (SLDm) and recommended care diet (RC)	Change from Baseline in Weight at 18 months	The experimental diet is the Stop Light Diet modified (SLDm) and includes PM, 35 F/V per week, and low energy shakes. The Investigators will compare this to the RC diet that uses traditional meal plans and includes 35 F/V per week. Weight to be measured following an overnight fast of approximately 12 hours. Weight will be measured in kg. Each person will be weighed in a hospital gown between 8 and 10 am, using a calibrated scale to the nearest 0.1kg.

Secondary Outcome Measures

Name	Time	Method
Comparison of chronic disease factors - Blood Pressure	Change from Baseline in Blood Pressure at 18 months	Changes in values of blood pressure between the two groups
Comparison of chronic disease factors - Glucose	Change from Baseline in Glucose at 18 months	Changes in values of glucose between the two groups
Comparison of chronic disease factors - HDL	Change from Baseline in HDL-cholesterol Pressure at 18 months	Changes in values of HDL-cholesterol between the two groups
Comparison of chronic disease factors - LDL	Change from Baseline in LDL-cholesterol Pressure at 18 months	Changes in values of LDL-cholesterol between the two groups
Comparison of chronic disease factors - Insulin	Change from Baseline in Insulin Pressure at 18 months	Changes in values of insulin between the two groups

Trial Locations

Locations (1)

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