Know Cancer

forgot password

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

18 Years
Open (Enrolling)
Weight Loss

Thank you

Trial Information

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

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

Type of Study:


Study Design:

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

Outcome Measure:

Weight loss between experimental diet (SLDm) and recommended care diet (RC)

Outcome Description:

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.

Outcome Time Frame:

Change from Baseline in Weight at 18 months

Safety Issue:


Principal Investigator

Joseph Donnelly, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas


United States: Food and Drug Administration

Study ID:




Start Date:

May 2011

Completion Date:

Related Keywords:

  • Weight Loss
  • Diet
  • Obesity
  • Chronic disease
  • Developmental Disabilities
  • Weight Loss



University of Kansas Medical Center Kansas City, Kansas  66160-7353