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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01724905
First Posted: November 12, 2012
Last Update Posted: December 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Joseph Donnelly, University of Kansas Medical Center Research Institute
  Purpose

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.


Condition Intervention
Weight Loss Dietary Supplement: Modified Stop Light Diet (SLDm) Dietary Supplement: Recommended Care Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Weight Loss and Maintenance for Individuals With Intellectual Developmental Disabilities (IDD)

Resource links provided by NLM:


Further study details as provided by Joseph Donnelly, University of Kansas Medical Center Research Institute:

Primary Outcome Measures:
  • Weight loss between experimental diet (SLDm) and recommended care diet (RC) [ Time Frame: Change from Baseline in Weight at 6 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.

  • Weight loss between experimental diet (SLDm) and recommended care diet (RC) [ Time Frame: 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:
  • Comparison of chronic disease factors - Blood Pressure [ Time Frame: 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 [ Time Frame: Change from Baseline in Glucose at 18 months ]
    Changes in values of glucose between the two groups

  • Comparison of chronic disease factors - HDL [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Change from Baseline in Insulin Pressure at 18 months ]
    Changes in values of insulin between the two groups


Enrollment: 151
Study Start Date: May 2011
Study Completion Date: July 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724905


Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Joseph Donnelly
Investigators
Principal Investigator: Joseph Donnelly, MD University of Kansas Medical Center
  More Information

Responsible Party: Joseph Donnelly, Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01724905     History of Changes
Other Study ID Numbers: 18808
First Submitted: October 1, 2012
First Posted: November 12, 2012
Last Update Posted: December 14, 2015
Last Verified: December 2015

Keywords provided by Joseph Donnelly, University of Kansas Medical Center Research Institute:
Diet
Obesity
Chronic disease

Additional relevant MeSH terms:
Body Weight
Weight Loss
Developmental Disabilities
Signs and Symptoms
Body Weight Changes
Neurodevelopmental Disorders
Mental Disorders