Weight Management for Adolescents With IDD

Weight Loss Clinical Trial

— IDDAdol  

Official title:

Weight Management for Adolescents With IDD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02561754
• Other study ID #: STUDY00001857
• Secondary ID: 5R01HD079642
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: May 5, 2021

Study information

• Verified date: February 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 5, 2021
• Est. primary completion date: May 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Developmental Disabilities
• Down Syndrome
• Intellectual Disability
• Weight Loss

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Energy Balance Lab, The University of Kansas	Lawrence	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Change at 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	Weight Change Across 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