Weight Management for Adolescents With IDD (IDDAdol)

February 7, 2023 updated by: University of Kansas Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
      • Lawrence, Kansas, United States, 66045
        • Energy Balance Lab, The University of Kansas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Face-To-Face/CD
Delivery: Face-to-face Diet: Conventional diet
Dietary supplement: Conventional Diet (CD)
CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet.
Behavioral: Face-to-face (FTF)
FTF will meet with a health educator in person and will track progress using pen and paper records for both physical activity and diet.
EXPERIMENTAL: Technology delivery/CD
Delivery: Technology Diet: Conventional diet
Dietary supplement: Conventional Diet (CD)
CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet.
Behavioral: Technology (TECH)
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.
Other: iPad with FaceTime
TECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field.
EXPERIMENTAL: Technology delivery/eSLD
Delivery: Technology Diet: enhanced Stop Light Diet
Behavioral: Technology (TECH)
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.
Other: iPad with FaceTime
TECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field.
Dietary supplement: Enhanced Stop Light Diet (eSLD)
eSDL includes reduced energy portion controlled meals for 6 months, encouraged consumption of lower energy shakes and 35 fruits and vegetables per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change in weight from baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change in weight from baseline to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

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

Investigators

  • Principal Investigator: Joseph E Donnelly, EdD, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (ACTUAL)

May 12, 2020

Study Completion (ACTUAL)

May 5, 2021

Study Registration Dates

First Submitted

June 25, 2015

First Submitted That Met QC Criteria

September 25, 2015

First Posted (ESTIMATE)

September 28, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001857
  • 5R01HD079642 (NIH)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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