Weight Management for Adolescents With IDD (IDDAdol)
Primary Purpose
Developmental Disabilities, Weight Loss, Body Weight
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Stop Light Diet (eSLD)
Conventional Diet (CD)
Face-to-face (FTF)
Technology (TECH)
iPad with FaceTime
Sponsored by
About this trial
This is an interventional treatment trial for Developmental Disabilities focused on measuring Diet, Obesity, Adolescents, Intellectual and Developmental Disability
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.
Sites / Locations
- University of Kansas Medical Center
- Energy Balance Lab, The University of Kansas
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Face-To-Face/CD
Technology delivery/CD
Technology delivery/eSLD
Arm Description
Delivery: Face-to-face Diet: Conventional diet
Delivery: Technology Diet: Conventional diet
Delivery: Technology Diet: enhanced Stop Light Diet
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02561754
First Posted
June 25, 2015
Last Updated
February 7, 2023
Sponsor
University of Kansas Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT02561754
Brief Title
Weight Management for Adolescents With IDD
Acronym
IDDAdol
Official Title
Weight Management for Adolescents With IDD
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
May 12, 2020 (Actual)
Study Completion Date
May 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Disabilities, Weight Loss, Body Weight, Down Syndrome, Body Weight Changes, Intellectual Disability
Keywords
Diet, Obesity, Adolescents, Intellectual and Developmental Disability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Face-To-Face/CD
Arm Type
Active Comparator
Arm Description
Delivery: Face-to-face Diet: Conventional diet
Arm Title
Technology delivery/CD
Arm Type
Experimental
Arm Description
Delivery: Technology Diet: Conventional diet
Arm Title
Technology delivery/eSLD
Arm Type
Experimental
Arm Description
Delivery: Technology Diet: enhanced Stop Light Diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Enhanced Stop Light Diet (eSLD)
Intervention Description
eSDL includes reduced energy portion controlled meals for 6 months, encouraged consumption of lower energy shakes and 35 fruits and vegetables per week.
Intervention Type
Dietary Supplement
Intervention Name(s)
Conventional Diet (CD)
Intervention Description
CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet.
Intervention Type
Behavioral
Intervention Name(s)
Face-to-face (FTF)
Intervention Description
FTF will meet with a health educator in person and will track progress using pen and paper records for both physical activity and diet.
Intervention Type
Behavioral
Intervention Name(s)
Technology (TECH)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
iPad with FaceTime
Intervention Description
TECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field.
Primary Outcome Measure Information:
Title
Weight Change at 6 Months
Description
Participants will be weighed in shorts and a t-shirt , on a calibrated scale to the nearest 0.1 kg.
Time Frame
Change in weight from baseline to 6 months
Secondary Outcome Measure Information:
Title
Weight Change Across 18 Months
Description
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.
Time Frame
Change in weight from baseline to 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph E Donnelly, EdD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Energy Balance Lab, The University of Kansas
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66045
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34915594
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.
Results Reference
derived
PubMed Identifier
34413247
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.
Results Reference
derived
Learn more about this trial
Weight Management for Adolescents With IDD
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