Clinical trial NCT02561754: Weight Management for Adolescents With IDD
Official title: Weight Management for Adolescents With IDD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Disabilities
Weight Loss
Body Weight
Down Syndrome
Body Weight Changes
Intellectual Disability
Keywords: Diet
Obesity
Adolescents
Intellectual and Developmental Disability
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2015-09-28
Enrollment: 110
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Weight Change at 6 Months
timeFrame: Change in weight from baseline to 6 months
Secondary outcomes:
measure: Weight Change Across 18 Months
timeFrame: Change in weight from baseline to 18 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lawrence
country: United States
facility: Energy Balance Lab, The University of Kansas
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Joseph E Donnelly, EdD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ptomey LT, Lee J, White DA, Helsel BC, Washburn RA, Donnelly JE. Changes in physical activity across a 6-month weight loss intervention in adolescents with intellectual and developmental disabilities. J Intellect Disabil Res. 2022 Jun;66(6):545-557. doi: 10.1111/jir.12909. Epub 2021 Dec 16.
citation: Ptomey LT, Washburn RA, Goetz JR, Sullivan DK, Gibson CA, Mayo MS, Krebill R, Gorczyca AM, Montgomery RN, Honas JJ, Helsel BC, Donnelly JE. Weight Loss Interventions for Adolescents With Intellectual Disabilities: An RCT. Pediatrics. 2021 Sep;148(3):e2021050261. doi: 10.1542/peds.2021-050261. Epub 2021 Aug 19.