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

NCT01724905 | Completed DMC

• 1 other identifier: 18808
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss

Keywords

Diet; Obesity; Chronic disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Comparison of chronic disease factors - Blood Pressure

  Change from Baseline in Blood Pressure at 18 months

• Comparison of chronic disease factors - Glucose

  Change from Baseline in Glucose at 18 months

• Comparison of chronic disease factors - HDL

  Change from Baseline in HDL-cholesterol Pressure at 18 months

• Comparison of chronic disease factors - LDL

  Change from Baseline in LDL-cholesterol Pressure at 18 months

• Comparison of chronic disease factors - Insulin

  Change from Baseline in Insulin Pressure at 18 months

Study Arms (2)

Modified Stop Light Diet

EXPERIMENTAL

Dietary Supplement: Modified Stop Light Diet (SLDm)

Recommended Care for Weight Reduction

ACTIVE COMPARATOR

Dietary Supplement: Recommended Care Diet

Interventions

Modified Stop Light Diet (SLDm) DIETARY_SUPPLEMENT

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

Modified Stop Light Diet

Recommended Care Diet DIETARY_SUPPLEMENT

RC diet includes traditional meal plans and 35 fruits and vegetables per week

Recommended Care for Weight Reduction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Joseph Donnelly: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (3)

• 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.

  PMID: 31944472 DERIVED

• 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.

  PMID: 29311038 DERIVED

• 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.

  PMID: 28707359 DERIVED

MeSH Terms

Conditions

Weight Loss; Obesity; Chronic Disease

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes

Study Officials

• Joseph Donnelly, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 1, 2012
• First Posted: November 12, 2012
• Study Start: May 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 14, 2015

Record last verified: 2015-12

Locations

US (1)