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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Kansas
Sponsor:
Information provided by (Responsible Party):
Joseph Donnelly, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01724905
First received: October 1, 2012
Last updated: January 8, 2014
Last verified: January 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Kansas:

Primary Outcome Measures:
  • Weight loss between experimental diet (SLDm) and recommended care diet (RC) [ Time Frame: Change from Baseline in Weight at 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Changes in values of insulin between the two groups


Estimated Enrollment: 162
Study Start Date: May 2011
Estimated Primary Completion Date: August 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724905

Contacts
Contact: Jeff Honas, MS, MPH 913-945-6009 jhonas2@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Jeff Honas, MS, MPH    913-945-6009    jhonas2@kumc.edu   
Sponsors and Collaborators
Joseph Donnelly
Investigators
Principal Investigator: Joseph Donnelly, MD University of Kansas
  More Information

No publications provided

Responsible Party: Joseph Donnelly, Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01724905     History of Changes
Other Study ID Numbers: 18808
Study First Received: October 1, 2012
Last Updated: January 8, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Kansas:
Diet
Obesity
Chronic disease

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

ClinicalTrials.gov processed this record on September 22, 2014