Developmental DisabilitiesIDDAdolNCT02561754

Weight Management for Adolescents With IDD

A study testing Enhanced Stop Light Diet (eSLD), Conventional Diet (CD) and Face-to-face (FTF) in people with Developmental Disabilities and Weight Loss, run by University of Kansas Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 13 to 21 years
Conditions the study is for: Developmental Disabilities, Weight Loss, Body Weight
What is being tested?: Enhanced Stop Light Diet (eSLD), Conventional Diet (CD) and Face-to-face (FTF)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 2 sitesUnited States
Study dates: Mar 2015to 5 May 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 to 21 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Kansas Medical Center
Kansas City, Kansas, 66160
Energy Balance Lab, The University of Kansas
Lawrence, Kansas, 66045

Other trials in United States

About this study

Read the 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.

Conditions: Developmental Disabilities, Weight Loss, Body Weight, Down Syndrome, Body Weight Changes, Intellectual Disability
Being tested: Enhanced Stop Light Diet (eSLD), Conventional Diet (CD), Face-to-face (FTF), Technology (TECH), iPad with FaceTime
Keywords: Diet, Obesity, Adolescents, Intellectual and Developmental Disability
Medical subject headings: Developmental Disabilities, Weight Loss, Body Weight, Down Syndrome, Body Weight Changes, Intellectual Disability, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enhanced Stop Light Diet (eSLD)Dietary supplement
eSDL includes reduced energy portion controlled meals for 6 months, encouraged consumption of lower energy shakes and 35 fruits and vegetables per week.
Conventional Diet (CD)Dietary supplement
CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet.
Face-to-face (FTF)Behavioural
FTF will meet with a health educator in person and will track progress using pen and paper records for both physical activity and diet.
Technology (TECH)Behavioural
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.
iPad with FaceTimeOther
TECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field.

Study groups in NCT02561754
Study group	Role	What they receive
Face-To-Face/CD	Active comparator	Delivery: Face-to-face Diet: Conventional diet Receives: Dietary Supplement: Conventional Diet (CD); Behavioral: Face-to-face (FTF)
Technology delivery/CD	Experimental	Delivery: Technology Diet: Conventional diet Receives: Dietary Supplement: Conventional Diet (CD); Behavioral: Technology (TECH); Other: iPad with FaceTime
Technology delivery/eSLD	Experimental	Delivery: Technology Diet: enhanced Stop Light Diet Receives: Dietary Supplement: Enhanced Stop Light Diet (eSLD); Behavioral: Technology (TECH); Other: iPad with FaceTime

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Change in weight from baseline to 6 months

Secondary outcomes (1)

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.
Measured: Change in weight from baseline to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 20155 May 2021

First posted28 Sep 2015 (estimated)
Study startMar 2015
Primary completion12 May 2020
Study completion5 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Developmental DisabilitiesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02561754
Sponsor's protocol ID: STUDY00001857
Other IDs: 5R01HD079642
Acronym: IDDAdol
Status last verified: Feb 2023
First submitted: 25 Jun 2015
Last updated: 10 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 37487764
Bodde 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.
PubMed 36604240
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.
PubMed 34915594
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.
PubMed 34413247

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Weight Management for Adolescents With IDD
ClinicalTrials.gov ID: NCT02561754
Acronym / sponsor ID: IDDAdol / STUDY00001857
Conditions: Developmental Disabilities, Weight Loss, Body Weight, Down Syndrome, Body Weight Changes, Intellectual Disability
Keywords: Diet, Obesity, Adolescents, Intellectual and Developmental Disability
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: University of Kansas Medical CenterUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: Mar 2015
Primary completion: 12 May 2020 (actual)
Study completion: 5 May 2021 (actual)
First posted: 28 Sep 2015 (estimated)
Results: Posted 10 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

group 1) Face-To-Face/CD

group 2) Technology delivery/CD

group 3) Technology delivery/eSLD.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Face-To-Face/CD	Active comparator	Dietary Supplement: Conventional Diet (CD), Behavioral: Face-to-face (FTF)Delivery: Face-to-face Diet: Conventional diet
Technology delivery/CD	Experimental	Dietary Supplement: Conventional Diet (CD), Behavioral: Technology (TECH), Other: iPad with FaceTimeDelivery: Technology Diet: Conventional diet
Technology delivery/eSLD	Experimental	Dietary Supplement: Enhanced Stop Light Diet (eSLD), Behavioral: Technology (TECH), Other: iPad with FaceTimeDelivery: Technology Diet: enhanced Stop Light Diet

Who may qualify

Ages: 13 to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Dietary supplement	Technology delivery/eSLD
Conventional Diet (CD)CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet.	Dietary supplement	Face-To-Face/CD, Technology delivery/CD
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.	Behavioural	Face-To-Face/CD
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.	Behavioural	Technology delivery/CD, Technology delivery/eSLD
iPad with FaceTimeTECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field.	Other	Technology delivery/CD, Technology delivery/eSLD

Primary outcome

Weight Change at 6 Months
Time frame: 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.

1 secondary outcome

Weight Change Across 18 Months
Time frame: Change in weight from baseline to 18 months

Results and safety

Results posted to the registry on 10 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Face-To-Face/CD	36	30
Technology Delivery/CD	39	33
Technology Delivery/eSLD	35	26

Primary outcome: Weight Change at 6 Months

Time frame: Change in weight from baseline to 6 months. Mean (Standard Deviation). Unit: kg

Measure	Face-To-Face/CD n = 35	Technology Delivery/CD n = 39	Technology Delivery/eSLD n = 30
Value	-0.3 (5.0)	-1.8 (4.0)	-5.0 (5.9)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Across 18 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Face-To-Face/CD	0 of 36 (0%)	0 of 36 (0%)	0 of 36
Technology Delivery/CD	0 of 39 (0%)	5 of 39 (12.8%)	0 of 39
Technology Delivery/eSLD	1 of 35 (2.9%)	1 of 35 (2.9%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37487764Bodde 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.
Derived from this study: PubMed 36604240Bodde 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.
Derived from this study: PubMed 34915594Ptomey 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.
Derived from this study: PubMed 34413247Ptomey 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joseph E Donnelly, EdD principal investigator

University of Kansas Medical Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight Change at 6 Months (time frame: Change in weight from baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02561754, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.