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Completed

NCT Number: NCT01724905

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

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.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Chronic Disease Disease Attributes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified Stop Light Diet (SLDm)

Dietary Supplement

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

Dietary Supplement

RC diet includes traditional meal plans and 35 fruits and vegetables per week

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Joseph Donnelly

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Nov 12, 2012
Registry last updated
Dec 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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