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

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss
• Intervention / Treatment: Dietary supplement: Modified Stop Light Diet (SLDm); Dietary supplement: Recommended Care Diet

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified Stop Light Diet	Dietary supplement: Modified Stop Light Diet (SLDm); SLDm includes reduced energy pre-packaged meals (PM) for 6 months, encouraged consumption of low energy shakes and 35 fruits and vegetables (F/V) per week
Active Comparator: Recommended Care for Weight Reduction	Dietary supplement: Recommended Care Diet; RC diet includes traditional meal plans and 35 fruits and vegetables per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss between experimental diet (SLDm) and recommended care diet (RC)	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.	Change from Baseline in Weight at 6 months
Weight loss between experimental diet (SLDm) and recommended care diet (RC)	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.	Change from Baseline in Weight at 18 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Joseph Donnelly
• Investigators: Principal Investigator: Joseph Donnelly, MD, University of Kansas Medical Center

Publications and helpful links

General Publications

• Ptomey LT, Willis EA, Sherman JR, White DA, Donnelly JE. Exploring the effectiveness of an 18-month weight management intervention in adults with Down syndrome using propensity score matching. J Intellect Disabil Res. 2020 Mar;64(3):221-233. doi: 10.1111/jir.12713. Epub 2020 Jan 15.
• Ptomey LT, Steger FL, Lee J, Sullivan DK, Goetz JR, Honas JJ, Washburn RA, Gibson CA, Donnelly JE. Changes in Energy Intake and Diet Quality during an 18-Month Weight-Management Randomized Controlled Trial in Adults with Intellectual and Developmental Disabilities. J Acad Nutr Diet. 2018 Jun;118(6):1087-1096. doi: 10.1016/j.jand.2017.11.003. Epub 2018 Jan 6.
• Ptomey LT, Willis EA, Lee J, Washburn RA, Gibson CA, Honas JJ, Donnelly JE. The feasibility of using pedometers for self-report of steps and accelerometers for measuring physical activity in adults with intellectual and developmental disabilities across an 18-month intervention. J Intellect Disabil Res. 2017 Aug;61(8):792-801. doi: 10.1111/jir.12392.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: October 1, 2012
• First Submitted That Met QC Criteria: November 7, 2012
• First Posted (Estimate): November 12, 2012

Study Record Updates

• Last Update Posted (Estimate): December 14, 2015
• Last Update Submitted That Met QC Criteria: December 10, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Obesity; Diet; Chronic disease
• Additional Relevant MeSH Terms: Mental Disorders; Body Weight Changes; Neurodevelopmental Disorders; Weight Loss; Body Weight; Developmental Disabilities
• Other Study ID Numbers: 18808