Healthy LifestyleNCT05211596
Deaf Weight Wise: Community-engaged Implementation Research to Promote Healthy Lifestyle Change With Deaf ASL Users
A study testing Deaf Weight Wise intervention in people with Healthy Lifestyle and Overweight, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of the Deaf Weight Wise Implementation Study is to study with diverse partners the approaches and strategies that lead to successful implementation of Deaf Weight Wise (DWW), an evidence-based healthy lifestyle intervention for use with Deaf adult American Sign Language (ASL) users. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle, Overweight, Obesity
- What is being tested?
- Deaf Weight Wise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2022to 28 Aug 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Deaf people who use sign language and live in one of the following three regions: Buffalo NY, Rochester NY, or Syracuse NY and/or part of the typical clientele/populations that the implementation partner sites serve;
- AND:
- Are Ages 18 and older
- Have a body mass index (BMI) of 18.5 or higher (normal BMI category or higher).
- Eligible subjects who wish to participate in the intervention component of the program (16-weeks plus 6-month maintenance phases) must also have permission from a healthcare provider to participate in the intervention if: 1) self-reported diagnosis of a recent cardiovascular disease event (heart attack or stroke in past 6 months), 2) self-reported heart condition, chest pain, dizziness, or other reason not to participate in physical activity, 3) had weight loss surgery in the previous 2 years (self-reported), 4) are pregnant (self-reported), and 5) has a BMI over 45.
- Subjects must also be willing to follow a healthy dietary pattern and to abstain from using weight loss medications during the study, and be willing and able to attend group sessions, and to participate in data collection requirements.
Who cannot join
- Those who are unable or unwilling to provide informed consent, and are unable to see and interact with computer-based questionnaires and educational interventions.
- Subjects with any of the following conditions who wish to participate in the intervention component of the program but do not have permission from a clinician may be instructed to abstain from specific intervention components, including those who reported 1) a cardiovascular disease event in the past six months, 2) or heart condition, chest pain, dizziness, or other reason not to participate in physical activity, 3) or weight loss surgery in the past two years, 4) are pregnant, or 5) has a BMI over 45.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Center for Deaf Health Research, University of Rochester
Rochester, New York, 14642
About this study
Official title: Deaf Weight Wise: Community-engaged Implementation Research to Promote Healthy Lifestyle Change With Deaf American Sign Language Users in Western and Central New York State
The purpose of the Deaf Weight Wise Implementation Study is to study with diverse partners the approaches and strategies that lead to successful implementation of Deaf Weight Wise (DWW), an evidence-based healthy lifestyle intervention for use with Deaf adult American Sign Language (ASL) users. The implementation hypothesis is that diverse community organizations will successfully implement DWW with their constituents.
Read the detailed description
Little is known about health or health promoting interventions in Deaf communities nationally or worldwide. Deaf individuals comprise understudied and medically underserved populations. Access to health services, research, and health information is confounded by communication and literacy barriers. One of the challenges of health research with deaf people is creating survey instruments and interventions that are culturally and linguistically appropriate. The original Deaf Weight-Wise Study (2012-2014) by this study team of the Rochester Prevention Research Center (RPRC): National Center for Deaf Health Research (NCDHR) was the first adequately powered randomized trial of an evidence-based healthy weight/lifestyle intervention to be carried out in Deaf people. Deaf Weight Wise is based on the University of North Carolina's Weight Wise program and represented a pioneering effort to collect new health information and develop intervention tools in a very understudied and underserved minority group. Deaf Weight Wise 2.0 (2017-2019) was built on this research team's experience with the original Deaf Weight Wise trial for ages 40-70, and was an adaptation of the original Deaf Weight Wise curriculum to suit ages 21-70. DWW 2.0 also evaluated the additional component of a one-to-one individual counseling intervention delivered remotely over videophone (like Skype/Zoom) in addition to the group intervention format.
This new Deaf Weight Wise implementation research proposed here will allow this study team to work with community partner organizations, to train them to implement DWW at their own sites. This will fulfill the goal of disseminating DWW broadly to Deaf communities. The study team will conduct research to study the process of implementation of DWW at each site. This advances DWW along the translational spectrum to ensure that DWW is not only a research project, but becomes a sustainable, community-based program.
The study team will conduct an implementation-effectiveness Type 3 research design that is plan, execute and evaluate in collaboration with partners. The study team will adapt and implement DWW with partner organizations at various sites in central and western NY. Each phase of this study, including selection of the intervention topic (obesity and healthy lifestyle), design of study procedures, and development of the informed consent and data collection processes, are based on direct input and feedback from Deaf research team members and Deaf community members.
All aspects of this research will be conducted via virtual video communication platforms.
Screening and enrollment is conducted in American Sign Language by Deaf sign-fluent research staff. Informed consent is an ASL video followed by discussion, question and answer, and check for comprehension in ASL by Deaf sign-fluent research staff. Following informed consent, subjects will have data collection appointments at baseline (pre-intervention), 6-months after baseline (post-intervention), and 18-months after baseline (1 year post-intervention). Data collection surveys are conducted via online ASL video surveys with English text support. Data collection interviews at all data collection points are conducted by Deaf sign-fluent research staff.
Following baseline appointments, a trained Deaf sign-fluent DWW intervention counselor from each implementation site will lead the group intervention via virtual video communication platform, with about 5 participants per group. As additional participants are enrolled, new groups will be formed (rolling enrollment at each site).
- Being tested
- Deaf Weight Wise intervention
- Keywords
- Deaf, American Sign Language
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deaf Weight Wise interventionBehavioural
Also called DWW
The DWW intervention consists of groups of 5 subjects who meet together for 16 weeks, 2 hours each week. Group meetings will be held virtually on Zoom. A trained, deaf, ASL-fluent counselor will lead the sessions. Each session includes group sharing, problem solving, discussion of a weight management topic, and goal setting and action planning for the next week. A key principle of DWW is motivational interviewing, in which the counselor acts as a facilitator to help participants identify/recognize their own unhealthy behaviors, help individuals build skills that will promote behavior change, and help group members to support each other to make behavior changes. The maintenance phase starts immediately after the 16-week intervention, and consists of two meetings of the original group via Zoom; one at month 3 and one at month 6 of the maintenance period. Counselors also email participants bi-weekly to check in and provide additional support.
| Study group | Role | What they receive |
|---|---|---|
| Single Intervention Arm (Main Intervention) | Other | Main Intervention Receives: Behavioral: Deaf Weight Wise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation of the Deaf Weight Wise Intervention at Partner Sites
This outcome measures implementation of the Deaf Weight Wise (DWW) intervention at partner sites, defined as the number of sites that enrolled participants.
Measured: Baseline to 18 Months
Delivery of the Deaf Weight Wise Intervention As Intended
This outcome measures the number of partner sites that delivered the Deaf Weight Wise (DWW) intervention as intended, based on predefined fidelity criteria (e.g., delivery by site-based coaches, completion of all planned sessions, adherence to the DWW curriculum). Fidelity was assessed through direct observation of sessions and bi-weekly counselor meetings. All intervention sessions were delivered remotely by NCDHR coaches via Zoom.
Measured: Baseline to 18 Months
Number of Participants Who Did Not Receive the Intervention at Their Partner Site Because of Site Barriers and/or COVID Restrictions
Measured: baseline to 18 months
Secondary outcomes (6)
Participant-Level Outcome: Mean Difference From Baseline to 6 Months (Pre- to Post-Intervention) in Number of Fruit and Vegetable Servings Per Day as Measured by the Block Fruit-Vegetable-Fiber Screener
The mean difference from baseline to 6 months (pre- to post-intervention) in self-reported fruit and vegetable servings per day as measured by the Block Fruit-Vegetable-Fiber Screener.
The Block Fruit-Vegetable-Fiber Screener is a 10-question survey with responses ranging from: (1) Less than 1/week to (5) 2+/day for each question. An algorithm is then used that incorporates the respondent's age and sex with the additive score from the questions to calculate the Predicted Value for Fruit and Vegetable Servings (Per Day).
Measured: Baseline to 6 Months (Pre- to Post-Intervention)
Participant-Level Outcome: Mean Difference From Baseline to 18 Months (Pre-Intervention to Post-Maintenance) in Number of Fruit and Vegetable Servings Per Day as Measured by the Block Fruit-Vegetable-Fiber Screener
The mean change from baseline to 18 months in self-reported physical activity as measured by the International Physical Activity Questionnaire (IPAQ) - Short Form. The IPAQ records days/week and minutes/day of walking, moderate, and vigorous activity. Scores are expressed in MET-minutes/week using standard values (Walking = 3.3, Moderate = 4.0, Vigorous = 8.0). The total IPAQ score is the sum of all activity categories. Scale range: minimum = 0 (no activity); no fixed maximum, values increase with more activity. Higher scores = better outcome (greater physical activity).
Measured: Baseline to 18 Months (Pre-Intervention to Post-Maintenance)
Participant-Level Outcome: Mean Difference From Baseline to 6 Months (Pre-Intervention to Post-Intervention) in Physical Activity as Reported on the International Physical Activity Question (IPAQ)
The mean change from baseline to 6 months in self-reported physical activity as measured by the International Physical Activity Questionnaire (IPAQ) - Short Form. The IPAQ records days/week and minutes/day of walking, moderate, and vigorous activity. Scores are expressed in MET-minutes/week using standard values (Walking = 3.3, Moderate = 4.0, Vigorous = 8.0). The total IPAQ score is the sum of all activity categories. Scale range: minimum = 0 (no activity); no fixed maximum, values increase with more activity. Higher scores = better outcome (greater physical activity).
Measured: Baseline to 6 Months (Pre- to Post-Intervention)
Participant-Level Outcome: Mean Difference From Baseline to 18 Months (Pre-Intervention to Post-Maintenance) in Physical Activity as Reported on the International Physical Activity Question (IPAQ)
The mean difference from baseline to 18 months (pre-intervention to post-maintenance) in self-reported physical activity levels over the past 7 days as reported on the International Physical Activity Question (IPAQ).
Measured: Baseline to 18 Months (Pre-Intervention to Post-Maintenance)
Participant-Level Outcome: Mean Percentage Difference From Baseline to 6 Months (Pre- to Post-Intervention) in Self-Reported Body Weight, for Participants With BMI Above Normal Range
The mean weight difference from baseline to 6 months (pre- to post-intervention), expressed as a percentage of baseline weight (in kg), for any participants with a BMI above 24.9 (above normal range)
Measured: Baseline to 6 Months (Pre- to Post-Intervention)
Participant-Level Outcome: Mean Percentage Difference From Baseline to 18 Months (Pre-Intervention to Post-Maintenance) in Self-Reported Body Weight, for Participants With BMI Above Normal Range
The mean weight difference from baseline to 18 months (pre-intervention to post-maintenance), expressed as a percentage of baseline weight (in kg), for any participants with a BMI above 24.9 (above normal range)
Measured: Baseline to 18 Months (Pre-Intervention to Post-Maintenance)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start2 Feb 2022
- Primary completion28 Aug 2024
- Study completion28 Aug 2024
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 Healthy LifestyleStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steve Barnett, University of Rochester
- Investigators
- Steven L Barnett, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211596
- Sponsor's protocol ID
- STUDY00005784
- Status last verified
- Oct 2025
- First submitted
- 25 Dec 2021
- Last updated
- 5 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completion of this study, deidentified participant dataset may be made available to interested researchers who fully complete the NCDHR Data Use agreement Process. This process includes a requirement to present the research plan to the NCDHR Research Committee and relevant Community Committee no more than 90 days prior to beginning the research project. In addition, results must be presented to the NCDHR Research Committee and relevant Community Committee within a 60-day period following the completion of the research project.
Publications
Samuel-Hodge CD, Johnston LF, Gizlice Z, Garcia BA, Lindsley SC, Bramble KP, Hardy TE, Ammerman AS, Poindexter PA, Will JC, Keyserling TC. Randomized trial of a behavioral weight loss intervention for low-income women: the Weight Wise Program. Obesity (Silver Spring). 2009 Oct;17(10):1891-9. doi: 10.1038/oby.2009.128. Epub 2009 Apr 30.
PubMed 19407810Barnett S, Matthews K, DeWindt L, Sutter E, Samuel-Hodge C, Yang H, Pearson TA; Deaf Weight Wise Study Group. Deaf Weight Wise: A novel randomized clinical trial with Deaf sign language users. Obesity (Silver Spring). 2023 Apr;31(4):965-976. doi: 10.1002/oby.23702. Epub 2023 Mar 8.
PubMed 36890106
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deaf Weight Wise: Community-engaged Implementation Research to Promote Healthy Lifestyle Change With Deaf American Sign Language Users in Western and Central New York State
- ClinicalTrials.gov ID
- NCT05211596
- Acronym / sponsor ID
- STUDY00005784
- Keywords
- Deaf, American Sign Language
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Posted 5 Nov 2025
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 the Deaf Weight Wise Implementation Study is to study with diverse partners the approaches and strategies that lead to successful implementation of Deaf Weight Wise (DWW), an evidence-based healthy lifestyle intervention for use with Deaf adult American Sign Language (ASL) users. The implementation hypothesis is that diverse community organizations will successfully implement DWW with their constituents.
Detailed description
Little is known about health or health promoting interventions in Deaf communities nationally or worldwide. Deaf individuals comprise understudied and medically underserved populations. Access to health services, research, and health information is confounded by communication and literacy barriers. One of the challenges of health research with deaf people is creating survey instruments and interventions that are culturally and linguistically appropriate. The original Deaf Weight-Wise Study (2012-2014) by this study team of the Rochester Prevention Research Center (RPRC): National Center for Deaf Health Research (NCDHR) was the first adequately powered randomized trial of an evidence-based healthy weight/lifestyle intervention to be carried out in Deaf people. Deaf Weight Wise is based on the University of North Carolina's Weight Wise program and represented a pioneering effort to collect new health information and develop intervention tools in a very understudied and underserved minority group. Deaf Weight Wise 2.0 (2017-2019) was built on this research team's experience with the original Deaf Weight Wise trial for ages 40-70, and was an adaptation of the original Deaf Weight Wise curriculum to suit ages 21-70. DWW 2.0 also evaluated the additional component of a one-to-one individual counseling intervention delivered remotely over videophone (like Skype/Zoom) in addition to the group intervention format.
This new Deaf Weight Wise implementation research proposed here will allow this study team to work with community partner organizations, to train them to implement DWW at their own sites. This will fulfill the goal of disseminating DWW broadly to Deaf communities. The study team will conduct research to study the process of implementation of DWW at each site. This advances DWW along the translational spectrum to ensure that DWW is not only a research project, but becomes a sustainable, community-based program.
The study team will conduct an implementation-effectiveness Type 3 research design that is plan, execute and evaluate in collaboration with partners. The study team will adapt and implement DWW with partner organizations at various sites in central and western NY. Each phase of this study, including selection of the intervention topic (obesity and healthy lifestyle), design of study procedures, and development of the informed consent and data collection processes, are based on direct input and feedback from Deaf research team members and Deaf community members.
All aspects of this research will be conducted via virtual video communication platforms.
Screening and enrollment is conducted in American Sign Language by Deaf sign-fluent research staff. Informed consent is an ASL video followed by discussion, question and answer, and check for comprehension in ASL by Deaf sign-fluent research staff. Following informed consent, subjects will have data collection appointments at baseline (pre-intervention), 6-months after baseline (post-intervention), and 18-months after baseline (1 year post-intervention). Data collection surveys are conducted via online ASL video surveys with English text support. Data collection interviews at all data collection points are conducted by Deaf sign-fluent research staff.
Following baseline appointments, a trained Deaf sign-fluent DWW intervention counselor from each implementation site will lead the group intervention via virtual video communication platform, with about 5 participants per group. As additional participants are enrolled, new groups will be formed (rolling enrollment at each site).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Intervention Arm (Main Intervention) | Other | Behavioral: Deaf Weight Wise interventionMain Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Deaf people who use sign language and live in one of the following three regions: Buffalo NY, Rochester NY, or Syracuse NY and/or part of the typical clientele/populations that the implementation partner sites serve;
- Are Ages 18 and older
- Have a body mass index (BMI) of 18.5 or higher (normal BMI category or higher).
- Eligible subjects who wish to participate in the intervention component of the program (16-weeks plus 6-month maintenance phases) must also have permission from a healthcare provider to participate in the intervention if: 1) self-reported diagnosis of a recent cardiovascular disease event (heart attack or stroke in past 6 months), 2) self-reported heart condition, chest pain, dizziness, or other reason not to participate in physical activity, 3) had weight loss surgery in the previous 2 years (self-reported), 4) are pregnant (self-reported), and 5) has a BMI over 45.
- Subjects must also be willing to follow a healthy dietary pattern and to abstain from using weight loss medications during the study, and be willing and able to attend group sessions, and to participate in data collection requirements.
Key exclusion criteria (2 listed)
- Those who are unable or unwilling to provide informed consent, and are unable to see and interact with computer-based questionnaires and educational interventions.
- Subjects with any of the following conditions who wish to participate in the intervention component of the program but do not have permission from a clinician may be instructed to abstain from specific intervention components, including those who reported 1) a cardiovascular disease event in the past six months, 2) or heart condition, chest pain, dizziness, or other reason not to participate in physical activity, 3) or weight loss surgery in the past two years, 4) are pregnant, or 5) has a BMI over 45.
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 |
|---|---|---|
| Deaf Weight Wise interventionAlso: DWWThe DWW intervention consists of groups of 5 subjects who meet together for 16 weeks, 2 hours each week. Group meetings will be held virtually on Zoom. A trained, deaf, ASL-fluent counselor will lead the sessions. Each session includes group sharing, problem solving, discussion of a weight management topic, and goal setting and action planning for the next week. A key principle of DWW is motivational interviewing, in which the counselor acts as a facilitator to help participants identify/recognize their own unhealthy behaviors, help individuals build skills that will promote behavior change, and help group members to support each other to make behavior changes. The maintenance phase starts immediately after the 16-week intervention, and consists of two meetings of the original group via Zoom; one at month 3 and one at month 6 of the maintenance period. Counselors also email participants bi-weekly to check in and provide additional support. | Behavioural | Single Intervention Arm (Main Intervention) |
Primary outcome
Implementation of the Deaf Weight Wise Intervention at Partner Sites
Time frame: Baseline to 18 Months
This outcome measures implementation of the Deaf Weight Wise (DWW) intervention at partner sites, defined as the number of sites that enrolled participants.
Delivery of the Deaf Weight Wise Intervention As Intended
Time frame: Baseline to 18 Months
This outcome measures the number of partner sites that delivered the Deaf Weight Wise (DWW) intervention as intended, based on predefined fidelity criteria (e.g., delivery by site-based coaches, completion of all planned sessions, adherence to the DWW curriculum). Fidelity was assessed through direct observation of sessions and bi-weekly counselor meetings. All intervention sessions were delivered remotely by NCDHR coaches via Zoom.
Number of Participants Who Did Not Receive the Intervention at Their Partner Site Because of Site Barriers and/or COVID Restrictions
Time frame: baseline to 18 months
6 secondary outcomes
Participant-Level Outcome: Mean Difference From Baseline to 6 Months (Pre- to Post-Intervention) in Number of Fruit and Vegetable Servings Per Day as Measured by the Block Fruit-Vegetable-Fiber Screener
Time frame: Baseline to 6 Months (Pre- to Post-Intervention)
Participant-Level Outcome: Mean Difference From Baseline to 18 Months (Pre-Intervention to Post-Maintenance) in Number of Fruit and Vegetable Servings Per Day as Measured by the Block Fruit-Vegetable-Fiber Screener
Time frame: Baseline to 18 Months (Pre-Intervention to Post-Maintenance)
Participant-Level Outcome: Mean Difference From Baseline to 6 Months (Pre-Intervention to Post-Intervention) in Physical Activity as Reported on the International Physical Activity Question (IPAQ)
Time frame: Baseline to 6 Months (Pre- to Post-Intervention)
Participant-Level Outcome: Mean Difference From Baseline to 18 Months (Pre-Intervention to Post-Maintenance) in Physical Activity as Reported on the International Physical Activity Question (IPAQ)
Time frame: Baseline to 18 Months (Pre-Intervention to Post-Maintenance)
Participant-Level Outcome: Mean Percentage Difference From Baseline to 6 Months (Pre- to Post-Intervention) in Self-Reported Body Weight, for Participants With BMI Above Normal Range
Time frame: Baseline to 6 Months (Pre- to Post-Intervention)
Participant-Level Outcome: Mean Percentage Difference From Baseline to 18 Months (Pre-Intervention to Post-Maintenance) in Self-Reported Body Weight, for Participants With BMI Above Normal Range
Time frame: Baseline to 18 Months (Pre-Intervention to Post-Maintenance)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19407810Samuel-Hodge CD, Johnston LF, Gizlice Z, Garcia BA, Lindsley SC, Bramble KP, Hardy TE, Ammerman AS, Poindexter PA, Will JC, Keyserling TC. Randomized trial of a behavioral weight loss intervention for low-income women: the Weight Wise Program. Obesity (Silver Spring). 2009 Oct;17(10):1891-9. doi: 10.1038/oby.2009.128. Epub 2009 Apr 30.
- Background: PubMed 36890106Barnett S, Matthews K, DeWindt L, Sutter E, Samuel-Hodge C, Yang H, Pearson TA; Deaf Weight Wise Study Group. Deaf Weight Wise: A novel randomized clinical trial with Deaf sign language users. Obesity (Silver Spring). 2023 Apr;31(4):965-976. doi: 10.1002/oby.23702. Epub 2023 Mar 8.
- NCDHR Deaf Weight Wise research websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After completion of this study, deidentified participant dataset may be made available to interested researchers who fully complete the NCDHR Data Use agreement Process. This process includes a requirement to present the research plan to the NCDHR Research Committee and relevant Community Committee no more than 90 days prior to beginning the research project. In addition, results must be presented to the NCDHR Research Committee and relevant Community Committee within a 60-day period following the completion of the research project.
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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.
Steven L Barnett, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deaf Weight Wise intervention in people with Healthy Lifestyle and Overweight, run by University of Rochester 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 6 inclusion and 2 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 5 Nov 2025. 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 5 Nov 2025). 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?
Implementation of the Deaf Weight Wise Intervention at Partner Sites (time frame: Baseline to 18 Months). The study lists 3 primary outcomes in all. 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 NCT05211596, 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 5 Nov 2025.