Weight Management for Adolescents With IDD

Not Applicable

Completed

Conditions: Weight Loss
Body Weight Changes
Intellectual Disability
Developmental Disabilities
Body Weight
Down Syndrome

Interventions: Dietary Supplement: Conventional Diet (CD)
Dietary Supplement: Enhanced Stop Light Diet (eSLD)
Behavioral: Face-to-face (FTF)
Behavioral: Technology (TECH)
Other: iPad with FaceTime

Brief 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.

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.

Recruitment & 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.

Arm && Interventions

Group	Intervention	Description
Face-To-Face/CD	Conventional Diet (CD)	Delivery: Face-to-face Diet: Conventional diet
Face-To-Face/CD	Face-to-face (FTF)	Delivery: Face-to-face Diet: Conventional diet
Technology delivery/CD	Conventional Diet (CD)	Delivery: Technology Diet: Conventional diet
Technology delivery/CD	iPad with FaceTime	Delivery: Technology Diet: Conventional diet
Technology delivery/eSLD	iPad with FaceTime	Delivery: Technology Diet: enhanced Stop Light Diet
Technology delivery/CD	Technology (TECH)	Delivery: Technology Diet: Conventional diet
Technology delivery/eSLD	Enhanced Stop Light Diet (eSLD)	Delivery: Technology Diet: enhanced Stop Light Diet
Technology delivery/eSLD	Technology (TECH)	Delivery: Technology Diet: enhanced Stop Light Diet

Primary Outcome Measures

Name	Time	Method
Weight Change at 6 Months	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 Outcome Measures

Name	Time	Method
Weight Change Across 18 Months	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.

Locations (2): Energy Balance Lab, The University of Kansas
🇺🇸
Lawrence, Kansas, United States
University of Kansas Medical Center
🇺🇸
Kansas City, Kansas, United States