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


N/A
18 Years
N/A
Open (Enrolling)
Both
Weight Loss

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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:

Interventional

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:

No

Principal Investigator

Joseph Donnelly, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas

Authority:

United States: Food and Drug Administration

Study ID:

18808

NCT ID:

NCT01724905

Start Date:

May 2011

Completion Date:

Related Keywords:

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

Name

Location

University of Kansas Medical CenterKansas City, Kansas  66160-7353