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Weight Management for Adolescents With IDD (IDDAdol)

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ClinicalTrials.gov Identifier: NCT02561754
Recruitment Status : Recruiting
First Posted : September 28, 2015
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Developmental Disabilities Weight Loss Body Weight Down Syndrome Body Weight Changes Intellectual Disability Dietary Supplement: Enhanced Stop Light Diet (eSLD) Dietary Supplement: Conventional Diet (CD) Behavioral: Face-to-face (FTF) Behavioral: Technology (TECH) Other: iPad with FaceTime Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Weight Management for Adolescents With IDD
Study Start Date : March 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : February 2020


Arm Intervention/treatment
Active Comparator: Face-To-Face/CD
Delivery: Face-to-face Diet: Conventional diet
Dietary Supplement: 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.

Experimental: Technology delivery/CD
Delivery: Technology Diet: Conventional diet
Dietary Supplement: Conventional Diet (CD)
CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet.

Behavioral: 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.

Experimental: Technology delivery/eSLD
Delivery: Technology Diet: enhanced Stop Light Diet
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.

Behavioral: 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.




Primary Outcome Measures :
  1. Weight loss between groups randomized to FTF/CD, TECH/CD and TECH/eSLD [ Time Frame: Change in weight from baseline to 6 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.


Secondary Outcome Measures :
  1. Weight change between groups randomized to FTF/CD, TECH/CD, or TECH/eSLD [ Time Frame: 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.

  2. Cost of the intervention delivery [ Time Frame: Accumulated cost of the intervention delivery from baseline to 18 months ]


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Ages Eligible for Study:   13 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02561754


Contacts
Contact: Lauren T Ptomey, PhD, RD, LD 913-945-8182 lptomey@kumc.edu
Contact: Jeff J Honas, MS 785-864-4163 jhonas@ku.edu

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Lauren T Ptomey, PhD, RD, LD    913-945-8182    lptomey@kumc.edu   
Principal Investigator: Joseph E Donnelly, EdD         
Energy Balance Lab, The University of Kansas Recruiting
Lawrence, Kansas, United States, 66045
Contact: Joseph Donnelly, EdD    785-864-0797    jdonnelly@ku.edu   
Principal Investigator: Joseph Donnelly, EdD         
Sponsors and Collaborators
University of Kansas Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Joseph E Donnelly, EdD University of Kansas Medical Center

Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02561754     History of Changes
Other Study ID Numbers: STUDY00001857
5R01HD079642 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2015    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Kansas Medical Center:
Diet
Obesity
Adolescents
Intellectual and Developmental Disability

Additional relevant MeSH terms:
Intellectual Disability
Developmental Disabilities
Body Weight
Weight Loss
Down Syndrome
Body Weight Changes
Signs and Symptoms
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders