Weight Management for Adolescents With IDD
IDDAdol
2 other identifiers
interventional
110
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2015
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 25, 2015
CompletedFirst Posted
Study publicly available on registry
September 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2021
CompletedResults Posted
Study results publicly available
February 10, 2023
CompletedFebruary 10, 2023
February 1, 2023
5.2 years
June 25, 2015
December 12, 2022
February 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Weight Change Across 18 Months
Change in weight from baseline to 18 months
Study Arms (3)
Face-To-Face/CD
ACTIVE COMPARATORDelivery: Face-to-face Diet: Conventional diet
Technology delivery/CD
EXPERIMENTALDelivery: Technology Diet: Conventional diet
Technology delivery/eSLD
EXPERIMENTALDelivery: Technology Diet: enhanced Stop Light Diet
Interventions
eSDL includes reduced energy portion controlled meals for 6 months, encouraged consumption of lower energy shakes and 35 fruits and vegetables per week.
CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet.
FTF will meet with a health educator in person 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.
TECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Energy Balance Lab, The University of Kansas
Lawrence, Kansas, 66045, United States
Related Publications (4)
Bodde AE, White DA, Forseth B, Hastert M, Washburn R, Donnelly J, Sullivan D, Ptomey LT. Parent factors associated with BMI, diet, and physical activity of adolescents with intellectual and developmental disabilities. Disabil Health J. 2023 Oct;16(4):101507. doi: 10.1016/j.dhjo.2023.101507. Epub 2023 Jul 7.
PMID: 37487764DERIVEDBodde AE, Helsel BC, Hastert M, Suire KB, Washburn RA, Donnelly JE, Ptomey LT. The prevalence of obesity and lifestyle behaviors of parents of youth with intellectual and developmental disabilities. Disabil Health J. 2023 Jul;16(3):101430. doi: 10.1016/j.dhjo.2022.101430. Epub 2022 Dec 14.
PMID: 36604240DERIVEDPtomey 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.
PMID: 34915594DERIVEDPtomey 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.
PMID: 34413247DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Joseph Donnelly
- Organization
- University of Kansas Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph E Donnelly, EdD
University of Kansas Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2015
First Posted
September 28, 2015
Study Start
March 1, 2015
Primary Completion
May 12, 2020
Study Completion
May 5, 2021
Last Updated
February 10, 2023
Results First Posted
February 10, 2023
Record last verified: 2023-02