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Deaf Weight Wise: Community-engaged Implementation Research to Promote Healthy Lifestyle Change With Deaf ASL Users

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05211596
Enrollment
85
Registered
2022-01-27
Start date
2022-02-02
Completion date
2024-08-28
Last updated
2025-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risks, Healthy Lifestyle, Implementation Research, Obesity, Overweight

Keywords

Deaf, American Sign Language

Brief 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. 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).

Interventions

BEHAVIORALDeaf Weight Wise intervention

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.

Sponsors

University of Rochester
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

• 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Implementation of the Deaf Weight Wise Intervention at Partner SitesBaseline to 18 MonthsThis 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 IntendedBaseline to 18 MonthsThis 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 Restrictionsbaseline to 18 months

Secondary

MeasureTime frameDescription
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)Baseline to 18 Months (Pre-Intervention to Post-Maintenance)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).
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 ScreenerBaseline to 6 Months (Pre- to Post-Intervention)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).
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 RangeBaseline to 18 Months (Pre-Intervention to Post-Maintenance)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)
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 RangeBaseline to 6 Months (Pre- to Post-Intervention)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)
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 ScreenerBaseline to 18 Months (Pre-Intervention to Post-Maintenance)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).
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)Baseline to 6 Months (Pre- to Post-Intervention)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).

Countries

United States

Participant flow

Recruitment details

Participants were recruited through various methods (e.g., outreach at community sites, social media) and enrolled on a rolling basis. The first participant was enrolled on Feb. 2, 2022, and the last on Aug. 1, 2023.

Pre-assignment details

All participants who completed the baseline survey and provided consent were considered enrolled.

Participants by arm

ArmCount
Behavioral: Deaf Weight Wise Intervention
Deaf Weight Wise is a group intervention lead by trained, American Sign Language (ASL)-fluent coaches, who utilize an existing evidence-based curriculum that emphasizes healthy eating, exercise, and lifestyle components. It is a behavior change intervention that uses motivational interviewing techniques to help participants identify/recognize unhealthy behaviors, build skills that will promote behavior change, and help group members to support each other to make behavior changes. Following baseline appointments, a coach from each implementation site led the group intervention via virtual video communication platform (Zoom), with about 5 participants per group. As additional participants enrolled, new groups were formed. Subjects were asked to complete a daily food and physical activity diary during the 16-week curriculum. Each session included a weigh-in, personal sharing and problem solving, discussion of a weight management topic, and a discussion on goal setting and action planning for the next week. After the 16-week curriculum, the intervention included a 6-month follow up and an 12-month maintenance phase. Following informed consent, data collection surveys were conducted via online ASL video surveys with English text support at baseline (pre-intervention), 6 months after baseline (post-intervention), and 18 months after baseline (post-maintenance). Data collection interviews at all data collection points were conducted by ASL-fluent research staff.
85
Total85

Withdrawals & dropouts

PeriodReasonFG000
6 Months to 18 MonthsLost to Follow-up9
Baseline to 6 MonthsDeath1
Baseline to 6 MonthsLost to Follow-up11
Baseline to 6 MonthsWithdrawal by Subject1

Baseline characteristics

CharacteristicBehavioral: Deaf Weight Wise Intervention
Age Became Deaf
Became deaf at age 3 or younger (incl. born deaf)
73 Participants
Age Became Deaf
Became deaf at age 4 or older
4 Participants
Age Became Deaf
Not reported
1 Participants
Age Became Deaf
Unknown
7 Participants
Age, Continuous50.66 Years
STANDARD_DEVIATION 13.76
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
78 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
Number of participants enrolled at each Implementation Site
Aurora of Central, NY (SYR)
0 Participants
Number of participants enrolled at each Implementation Site
Buffalo Club for the Deaf (BUF)
0 Participants
Number of participants enrolled at each Implementation Site
Deaf Access Services (of People, Inc.) (BUF)
5 Participants
Number of participants enrolled at each Implementation Site
Deaf Wellness Center (ROC)
11 Participants
Number of participants enrolled at each Implementation Site
Rochester Institute of Technology (ROC)
23 Participants
Number of participants enrolled at each Implementation Site
Rochester Recreation Club for the Deaf (ROC)
13 Participants
Number of participants enrolled at each Implementation Site
Rochester View Apartments (ROC)
11 Participants
Number of participants enrolled at each Implementation Site
WHOLE ME, Inc. (SYR)
13 Participants
Number of participants enrolled at each Implementation Site
YMCA of Greater Rochester (ROC)
4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants
Race (NIH/OMB)
Asian
4 Participants
Race (NIH/OMB)
Black or African American
7 Participants
Race (NIH/OMB)
More than one race
5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants
Race (NIH/OMB)
White
62 Participants
Region of Enrollment
United States
85 Participants
Sex/Gender, Customized
Female
60 Participants
Sex/Gender, Customized
Male
22 Participants
Sex/Gender, Customized
Other
3 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
1 / 85
other
Total, other adverse events
0 / 85
serious
Total, serious adverse events
0 / 85

Outcome results

Primary

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.

Time frame: Baseline to 18 Months

ArmMeasureValue (COUNT_OF_UNITS)
Deaf Weight Wise Intervention Partner Site ImplementationDelivery of the Deaf Weight Wise Intervention As Intended0 Partner Sites
Primary

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.

Time frame: Baseline to 18 Months

ArmMeasureValue (COUNT_OF_UNITS)
Deaf Weight Wise Intervention Partner Site ImplementationImplementation of the Deaf Weight Wise Intervention at Partner Sites7 Partner Sites
Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Deaf Weight Wise Intervention Partner Site ImplementationNumber of Participants Who Did Not Receive the Intervention at Their Partner Site Because of Site Barriers and/or COVID Restrictions85 Participants
Secondary

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).

Time frame: Baseline to 18 Months (Pre-Intervention to Post-Maintenance)

Population: Data from 58 participants were used in this analysis. Of the 63 participants who completed the second period of the intervention (baseline to 18 months), 5 did not submit the Block Fruit-Vegetable-Fiber Screener.

ArmMeasureGroupValue (MEAN)Dispersion
Deaf Weight Wise Intervention Partner Site ImplementationParticipant-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 ScreenerBaseline5.62 Fruit and Vegetable Servings per DayStandard Deviation 1.57
Deaf Weight Wise Intervention Partner Site ImplementationParticipant-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 Screener18 Months5.83 Fruit and Vegetable Servings per DayStandard Deviation 1.32
p-value: 0.264t-test, 2 sided
Secondary

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).

Time frame: Baseline to 18 Months (Pre-Intervention to Post-Maintenance)

Population: Data from 50 participants were used in this analysis. Of the 63 participants who completed the second period of the intervention (baseline to 18 months), 13 did not submit the 18-month IPAQ.

ArmMeasureGroupValue (MEAN)Dispersion
Deaf Weight Wise Intervention Partner Site ImplementationParticipant-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)Baseline1409.73 Score on a scaleStandard Deviation 1481.73
Deaf Weight Wise Intervention Partner Site ImplementationParticipant-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)18 Months2187.14 Score on a scaleStandard Deviation 2527.1
p-value: 0.054t-test, 2 sided
Secondary

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).

Time frame: Baseline to 6 Months (Pre- to Post-Intervention)

Population: Data from 57 participants were used in this analysis. Of the 72 participants who completed the first period of the intervention (baseline to 6 months), 15 did not submit the 6-month IPAQ.

ArmMeasureGroupValue (MEAN)Dispersion
Deaf Weight Wise Intervention Partner Site ImplementationParticipant-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)Baseline1611.43 Score on a scaleStandard Deviation 1588.29
Deaf Weight Wise Intervention Partner Site ImplementationParticipant-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)6 Months2460.79 Score on a scaleStandard Deviation 1965.77
p-value: 0.003t-test, 2 sided
Secondary

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).

Time frame: Baseline to 6 Months (Pre- to Post-Intervention)

Population: Data from 67 participants were used in this analysis. Of the 72 participants who completed the first period of the intervention (baseline to 6 months), 5 did not submit the Block Fruit-Vegetable-Fiber Screener.

ArmMeasureGroupValue (MEAN)Dispersion
Deaf Weight Wise Intervention Partner Site ImplementationParticipant-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 ScreenerBaseline5.70 Fruit and Vegetable Servings per DayStandard Deviation 1.56
Deaf Weight Wise Intervention Partner Site ImplementationParticipant-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 Screener6 Months6.13 Fruit and Vegetable Servings per DayStandard Deviation 1.55
p-value: 0.008t-test, 2 sided
Secondary

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)

Time frame: Baseline to 18 Months (Pre-Intervention to Post-Maintenance)

Population: Data from 56 participants were used in this analysis. Out of 76 participants with a BMI \> 24.9, 56 had weight data at 18 months.

ArmMeasureGroupValue (MEAN)Dispersion
Deaf Weight Wise Intervention Partner Site ImplementationParticipant-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 RangeBaseline0.00 percentage of baseline weightStandard Deviation 0
Deaf Weight Wise Intervention Partner Site ImplementationParticipant-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 Range18 Months-0.04 percentage of baseline weightStandard Deviation 0.06
p-value: <0.001t-test, 2 sided
Secondary

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)

Time frame: Baseline to 6 Months (Pre- to Post-Intervention)

Population: Data from 63 participants were used in this analysis. Out of 76 participants with a BMI \> 24.9, 63 had weight data at 6 months.

ArmMeasureGroupValue (MEAN)Dispersion
Deaf Weight Wise Intervention Partner Site ImplementationParticipant-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 RangeBaseline0.00 percentage of baseline weightStandard Deviation 0
Deaf Weight Wise Intervention Partner Site ImplementationParticipant-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 Range6 Months-0.04 percentage of baseline weightStandard Deviation 0.05
p-value: <0.001t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026