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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01724905
• Other study ID #: 18808
• Status: Completed
• Phase: N/A
• First received: October 1, 2012
• Last updated: December 10, 2015
• Start date: May 2011
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: July 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Developmental Disabilities
• Weight Loss

Intervention

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
• Recommended Care Diet
RC diet includes traditional meal plans and 35 fruits and vegetables per week

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Joseph Donnelly

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Comparison of chronic disease factors - Glucose	Changes in values of glucose between the two groups	Change from Baseline in Glucose at 18 months	No
Secondary	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	No
Secondary	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	No
Secondary	Comparison of chronic disease factors - Insulin	Changes in values of insulin between the two groups	Change from Baseline in Insulin Pressure at 18 months	No