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Completed

NCT Number: NCT02561754

Weight Management for Adolescents With IDD

The goal of this study is to explore the impact of two different diets (conventional vs. enhanced stop light) and two different delivery systems (face-to-face vs. remote) on weight across 18 months in overweight and obese adolescents with intellectual and developmental disabilities.

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Key information

Conditions

Developmental Disabilities Abnormalities, Multiple Body Weight Body Weight Changes Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Intellectual Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

13 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center, Kansas City, Kansas, United States

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About this study

Rates of obesity and obesity related chronic health conditions are higher in adolescents with Intellectual and Developmental Disabilities (IDD) than those in the general population. Many of the negative health consequences observed in obese adults are already present in obese adolescents with IDD.

This study is a 3 group randomized trial to evaluate the intervention delivery system and type of reduced energy diet. The investigators will randomize 123 overweight/obese adolescents with mild to moderate IDD to one of 3 groups for an 18 month trial (6 month weight loss; 12 month weight maintenance):

group 1) Face-To-Face/CD

group 2) Technology delivery/CD

group 3) Technology delivery/eSLD.

All participants will receive a progressive program of physical activity. Participants on the CD diet will be asked to consume a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet. Participants on the eSLD will consume pre-packaged portion controlled meals with the addition of 5 fruits and vegetables per day.

FTF will meet with a health educator and will track progress using pen and paper records for both physical activity and diet. TECH groups will receive the intervention using an iPad with the FaceTimeTM application for video meetings with a health educator and will track progress using the Lose it! application for both physical activity and diet.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 13-21 yrs
  • Mild (IQ of 74-50) or moderate (IQ 40-49) IDD,
  • Of sufficient functional ability to understand directions, communicate preferences (e.g. foods), wants (e.g. more to eat/drink), and needs (e.g. assistance with food preparation) through spoken language.
  • Overweight or obese (BMI ≥ 85th%ile on CDC growth charts, or waist circumference to height ratio > 0.5
  • Living at home with a parent or guardian.
  • Internet access in the home.
  • No plans to relocate outside the study area over the next 18 mos
  • Physician consent for PA and diet.

Exclusion criteria

  • Insulin dependent diabetes
  • Participation in a weight management program involving diet and PA in the past 6 mos
  • Eating disorders, serious food allergies, consuming special diets, aversion to common foods,
  • Diagnosis of Prader-Willi Syndrome
  • Currently pregnant, planning on/becoming pregnant during the study.
  • Unable to participate in moderate to vigorous PA.

Treatment and study plan

Enhanced Stop Light Diet (eSLD)

Dietary Supplement

eSDL includes reduced energy portion controlled meals for 6 months, encouraged consumption of lower energy shakes and 35 fruits and vegetables per week.

Conventional Diet (CD)

Dietary Supplement

CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet.

Face-to-face (FTF)

Behavioral

FTF will meet with a health educator in person and will track progress using pen and paper records for both physical activity and diet.

Technology (TECH)

Behavioral

TECH groups will receive the intervention using an iPad with the FaceTimeTM application for video meetings with a health educator and will track progress using the Lose it! application for both physical activity and diet.

iPad with FaceTime

Other

TECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field.

Primary outcomes

  1. Weight Change at 6 Months

    Time frame: Change in weight from baseline to 6 months

    Participants will be weighed in shorts and a t-shirt , on a calibrated scale to the nearest 0.1 kg.

Secondary outcomes

  1. Weight Change Across 18 Months

    Time frame: Change in weight from baseline to 18 months

    Participants will be weighed in shorts and a t-shirt between 7 and 10 AM, in duplicate, on a calibrated scale to the nearest 0.1 kg.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: IDDAdol

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Sep 28, 2015
Registry last updated
Feb 10, 2023

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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