ObesityNCT03291509
Remote Delivery of Weight Management for Adults With IDD
A study testing Video Conference Meetings, In-person Meetings and Enhanced Stop Light Diet in people with Obesity, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare different weight loss programs in people with IDD to see which program works better. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Video Conference Meetings, In-person Meetings and Enhanced Stop Light Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2018to 14 Aug 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of mild to moderate IDD as determined by a Community Service Provider operating in Kansas under the auspices of a Community Developmental Disability Organization (CDDO). Participants will be judged competent to provide informed consent by their CDDO, or will have a guardian with power of attorney.
- Ability to provide assent, regardless of guardian consent.
- BMI of 25 to 45 kg/m2
- 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
- Living at home with a parent/guardian, or in a supported living environment with a caregiver who assists with food shopping, meal planning, and meal preparation and agrees to serve as a study partner
- No plans to relocate outside the study area over the next 24 months
- Internet access in the home
Who cannot join
- Unable to participate in moderate-to-vigorous physical activity (MVPA)
- Insulin dependent diabetes
- Participation in a weight management program involving diet and physical activity in the past 6 months
- Serious food allergies, consuming special diets (vegetarian, Atkins etc.), aversion to common foods (e.g., unwilling to consume dairy products, vegetables), diagnosis of Prader-Willi Syndrome
- Pregnancy during the previous 6 months, currently lactating or planned pregnancy in the following 24 months.
- Serious medical risk, e.g., cancer, recent heart attack, stroke, angioplasty
- Unwilling to be randomized.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Remote Delivery of Weight Management for Adults With Intellectual and Developmental Disabilities (IDD)
The purpose of this study is to compare different weight loss programs in people with IDD to see which program works better.
- Conditions
- Obesity
- Being tested
- Video Conference Meetings, In-person Meetings, Enhanced Stop Light Diet, Physical Activity
- Keywords
- weight loss, weight management
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Conference MeetingsBehavioural
Individual video conferencing with a health educator using an iPad.
In-person MeetingsBehavioural
Individual face-to-face (FTF) meetings with a health educator.
Enhanced Stop Light DietBehavioural
Also called eSLD
Diet composed of healthy, pre-packaged meals, balance of fruits, vegetables, and low calories snacks, and shakes. Participants and study partners will be trained to use a color coded chart which categorize foods based on the Stop Light system (green, yellow, red) to assist in meal planning, grocery shopping, decisions regarding snack foods, and compliance with the diet in special situations such as eating away from home (restaurants, parties, etc.).
Physical ActivityBehavioural
Participants will be asked to complete a set amount of time of moderate-to-vigorous physical activity each week. Participants in the Computer group will be asked to attend remote exercise sessions 2 times a week.
| Study group | Role | What they receive |
|---|---|---|
| In-person Group | Active comparator | Participants randomized to this group will have a health educator to their house for in-person meetings. Participants will use paper forms to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week. Receives: Behavioral: In-person Meetings; Behavioral: Enhanced Stop Light Diet; Behavioral: Physical Activity |
| Computer Group | Experimental | Participants randomized to this group will use an iPad to talk to the health educator via video conference meetings. Participants will use the iPad to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week. Receives: Behavioral: Video Conference Meetings; Behavioral: Enhanced Stop Light Diet; Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight (kg)
Change in weight (kg) from baseline to 6 months
Measured: Change from Baseline to Month 6
Secondary outcomes (1)
Change in Weight (kg)
Change in weight across the 24 month study
Measured: Change from Baseline to Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start21 Feb 2018
- Primary completion16 Mar 2021
- Study completion14 Aug 2022
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 (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Donnelly, PhD, Principal investigator, University of Kansas Medical CenterLauren T Ptomey, PhD, RD, LD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291509
- Sponsor's protocol ID
- STUDY00140653
- Other IDs
- R01DK114121-01
- Status last verified
- Feb 2023
- First submitted
- 19 Sep 2017
- Last updated
- 7 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ptomey LT, Washburn RA, Sherman JR, Mayo MS, Krebill R, Szabo-Reed AN, Honas JJ, Helsel BC, Bodde A, Donnelly JE. Remote delivery of a weight management intervention for adults with intellectual disabilities: Results from a randomized non-inferiority trial. Disabil Health J. 2024 Apr;17(2):101587. doi: 10.1016/j.dhjo.2024.101587. Epub 2024 Jan 22.
PubMed 38272776Ptomey LT, Washburn RA, Mayo MS, Greene JL, Lee RH, Szabo-Reed AN, Honas JJ, Sherman JR, Donnelly JE. Remote delivery of weight management for adults with intellectual and developmental disabilities: Rationale and design for a 24 month randomized trial. Contemp Clin Trials. 2018 Oct;73:16-26. doi: 10.1016/j.cct.2018.08.010. Epub 2018 Aug 24.
PubMed 30145269
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Delivery of Weight Management for Adults With Intellectual and Developmental Disabilities (IDD)
- ClinicalTrials.gov ID
- NCT03291509
- Acronym / sponsor ID
- STUDY00140653
- Conditions
- Obesity
- Keywords
- weight loss, weight management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 16 Mar 2021 (actual)
- Study completion
- 14 Aug 2022 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Posted 7 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare different weight loss programs in people with IDD to see which program works better.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-person Group | Active comparator | Behavioral: In-person Meetings, Behavioral: Enhanced Stop Light Diet, Behavioral: Physical ActivityParticipants randomized to this group will have a health educator to their house for in-person meetings. Participants will use paper forms to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week. |
| Computer Group | Experimental | Behavioral: Video Conference Meetings, Behavioral: Enhanced Stop Light Diet, Behavioral: Physical ActivityParticipants randomized to this group will use an iPad to talk to the health educator via video conference meetings. Participants will use the iPad to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of mild to moderate IDD as determined by a Community Service Provider operating in Kansas under the auspices of a Community Developmental Disability Organization (CDDO). Participants will be judged competent to provide informed consent by their CDDO, or will have a guardian with power of attorney.
- Ability to provide assent, regardless of guardian consent.
- BMI of 25 to 45 kg/m2
- 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
- Living at home with a parent/guardian, or in a supported living environment with a caregiver who assists with food shopping, meal planning, and meal preparation and agrees to serve as a study partner
Key exclusion criteria (7 listed)
- Unable to participate in moderate-to-vigorous physical activity (MVPA)
- Insulin dependent diabetes
- Participation in a weight management program involving diet and physical activity in the past 6 months
- Serious food allergies, consuming special diets (vegetarian, Atkins etc.), aversion to common foods (e.g., unwilling to consume dairy products, vegetables), diagnosis of Prader-Willi Syndrome
- Pregnancy during the previous 6 months, currently lactating or planned pregnancy in the following 24 months.
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 |
|---|---|---|
| Video Conference MeetingsIndividual video conferencing with a health educator using an iPad. | Behavioural | Computer Group |
| In-person MeetingsIndividual face-to-face (FTF) meetings with a health educator. | Behavioural | In-person Group |
| Enhanced Stop Light DietAlso: eSLDDiet composed of healthy, pre-packaged meals, balance of fruits, vegetables, and low calories snacks, and shakes. Participants and study partners will be trained to use a color coded chart which categorize foods based on the Stop Light system (green, yellow, red) to assist in meal planning, grocery shopping, decisions regarding snack foods, and compliance with the diet in special situations such as eating away from home (restaurants, parties, etc.). | Behavioural | Computer Group, In-person Group |
| Physical ActivityParticipants will be asked to complete a set amount of time of moderate-to-vigorous physical activity each week. Participants in the Computer group will be asked to attend remote exercise sessions 2 times a week. | Behavioural | Computer Group, In-person Group |
Primary outcome
Change in Weight (kg)
Time frame: Change from Baseline to Month 6
Change in weight (kg) from baseline to 6 months
1 secondary outcome
Change in Weight (kg)
Time frame: Change from Baseline to Month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38272776Ptomey LT, Washburn RA, Sherman JR, Mayo MS, Krebill R, Szabo-Reed AN, Honas JJ, Helsel BC, Bodde A, Donnelly JE. Remote delivery of a weight management intervention for adults with intellectual disabilities: Results from a randomized non-inferiority trial. Disabil Health J. 2024 Apr;17(2):101587. doi: 10.1016/j.dhjo.2024.101587. Epub 2024 Jan 22.
- Derived from this study: PubMed 30145269Ptomey LT, Washburn RA, Mayo MS, Greene JL, Lee RH, Szabo-Reed AN, Honas JJ, Sherman JR, Donnelly JE. Remote delivery of weight management for adults with intellectual and developmental disabilities: Rationale and design for a 24 month randomized trial. Contemp Clin Trials. 2018 Oct;73:16-26. doi: 10.1016/j.cct.2018.08.010. Epub 2018 Aug 24.
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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 Donnelly, PhD principal investigator
University of Kansas Medical Center
Lauren T Ptomey, PhD, RD, LD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Conference Meetings, In-person Meetings and Enhanced Stop Light Diet in people with Obesity, run by University of Kansas Medical Center at 1 site in United States.
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 7 inclusion and 7 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 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 7 Mar 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?
Change in Weight (kg) (time frame: Change from Baseline to Month 6). 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 NCT03291509, which also lists 2 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 7 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.