Trial Outcomes & Findings for Deaf Weight Wise: Community-engaged Implementation Research to Promote Healthy Lifestyle Change With Deaf ASL Users (NCT NCT05211596)

Last Updated: 2025-11-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

85 participants

Primary outcome timeframe

Baseline to 18 Months

Results posted on

2025-11-05

Participant Flow

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.

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

Participant milestones

Participant milestones
Measure	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.
Baseline to 6 Months STARTED	85
Baseline to 6 Months COMPLETED	72
Baseline to 6 Months NOT COMPLETED	13
6 Months to 18 Months STARTED	72
6 Months to 18 Months COMPLETED	63
6 Months to 18 Months NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Baseline to 6 Months Lost to Follow-up	11
Baseline to 6 Months Death	1
Baseline to 6 Months Withdrawal by Subject	1
6 Months to 18 Months Lost to Follow-up	9

Baseline Characteristics

5 participants are not included in this baseline measure because they were not recruited through a site, they were recruited directly online with NCDHR.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Behavioral: Deaf Weight Wise Intervention n=85 Participants 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.
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=85 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=85 Participants
Race (NIH/OMB) Asian	4 Participants n=85 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=85 Participants
Race (NIH/OMB) Black or African American	7 Participants n=85 Participants
Race (NIH/OMB) White	62 Participants n=85 Participants
Race (NIH/OMB) More than one race	5 Participants n=85 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=85 Participants
Region of Enrollment United States	85 Participants n=85 Participants
Age Became Deaf Became deaf at age 3 or younger (incl. born deaf)	73 Participants n=85 Participants
Age Became Deaf Became deaf at age 4 or older	4 Participants n=85 Participants
Age Became Deaf Unknown	7 Participants n=85 Participants
Age Became Deaf Not reported	1 Participants n=85 Participants
Number of participants enrolled at each Implementation Site Deaf Access Services (of People, Inc.) (BUF)	5 Participants n=80 Participants • 5 participants are not included in this baseline measure because they were not recruited through a site, they were recruited directly online with NCDHR.
Number of participants enrolled at each Implementation Site Buffalo Club for the Deaf (BUF)	0 Participants n=80 Participants • 5 participants are not included in this baseline measure because they were not recruited through a site, they were recruited directly online with NCDHR.
Number of participants enrolled at each Implementation Site WHOLE ME, Inc. (SYR)	13 Participants n=80 Participants • 5 participants are not included in this baseline measure because they were not recruited through a site, they were recruited directly online with NCDHR.
Number of participants enrolled at each Implementation Site Aurora of Central, NY (SYR)	0 Participants n=80 Participants • 5 participants are not included in this baseline measure because they were not recruited through a site, they were recruited directly online with NCDHR.
Age, Continuous	50.66 Years STANDARD_DEVIATION 13.76 • n=85 Participants
Sex/Gender, Customized Female	60 Participants n=85 Participants
Sex/Gender, Customized Male	22 Participants n=85 Participants
Sex/Gender, Customized Other	3 Participants n=85 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=85 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	78 Participants n=85 Participants
Number of participants enrolled at each Implementation Site Rochester View Apartments (ROC)	11 Participants n=80 Participants • 5 participants are not included in this baseline measure because they were not recruited through a site, they were recruited directly online with NCDHR.
Number of participants enrolled at each Implementation Site Deaf Wellness Center (ROC)	11 Participants n=80 Participants • 5 participants are not included in this baseline measure because they were not recruited through a site, they were recruited directly online with NCDHR.
Number of participants enrolled at each Implementation Site Rochester Institute of Technology (ROC)	23 Participants n=80 Participants • 5 participants are not included in this baseline measure because they were not recruited through a site, they were recruited directly online with NCDHR.
Number of participants enrolled at each Implementation Site Rochester Recreation Club for the Deaf (ROC)	13 Participants n=80 Participants • 5 participants are not included in this baseline measure because they were not recruited through a site, they were recruited directly online with NCDHR.
Number of participants enrolled at each Implementation Site YMCA of Greater Rochester (ROC)	4 Participants n=80 Participants • 5 participants are not included in this baseline measure because they were not recruited through a site, they were recruited directly online with NCDHR.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Deaf Weight Wise Intervention Partner Site Implementation n=9 Partner Sites The DWW study team worked with community partner organizations to train them to implement DWW at their own sites. The goal was to disseminate DWW broadly to Deaf communities. Working with partner organizations, the study team adapted DWW and supported implementation at various sites in central and western NY. The study team conducted an implementation-effectiveness Type 3 research design to plan, execute, and evaluate in collaboration with partners. Through the process, the study team evaluated whether DWW was implemented and whether it was delivered as intended.
Implementation of the Deaf Weight Wise Intervention at Partner Sites	7 Partner Sites

PRIMARY outcome

Timeframe: Baseline to 18 Months

Outcome measures

Outcome measures
Measure	Deaf Weight Wise Intervention Partner Site Implementation n=9 Partner Sites The DWW study team worked with community partner organizations to train them to implement DWW at their own sites. The goal was to disseminate DWW broadly to Deaf communities. Working with partner organizations, the study team adapted DWW and supported implementation at various sites in central and western NY. The study team conducted an implementation-effectiveness Type 3 research design to plan, execute, and evaluate in collaboration with partners. Through the process, the study team evaluated whether DWW was implemented and whether it was delivered as intended.
Delivery of the Deaf Weight Wise Intervention As Intended	0 Partner Sites

PRIMARY outcome

Timeframe: baseline to 18 months

Outcome measures

Outcome measures
Measure	Deaf Weight Wise Intervention Partner Site Implementation n=85 Participants The DWW study team worked with community partner organizations to train them to implement DWW at their own sites. The goal was to disseminate DWW broadly to Deaf communities. Working with partner organizations, the study team adapted DWW and supported implementation at various sites in central and western NY. The study team conducted an implementation-effectiveness Type 3 research design to plan, execute, and evaluate in collaboration with partners. Through the process, the study team evaluated whether DWW was implemented and whether it was delivered as intended.
Number of Participants Who Did Not Receive the Intervention at Their Partner Site Because of Site Barriers and/or COVID Restrictions	85 Participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Deaf Weight Wise Intervention Partner Site Implementation n=67 Participants The DWW study team worked with community partner organizations to train them to implement DWW at their own sites. The goal was to disseminate DWW broadly to Deaf communities. Working with partner organizations, the study team adapted DWW and supported implementation at various sites in central and western NY. The study team conducted an implementation-effectiveness Type 3 research design to plan, execute, and evaluate in collaboration with partners. Through the process, the study team evaluated whether DWW was implemented and whether it was delivered as intended.
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 Baseline	5.70 Fruit and Vegetable Servings per Day Standard Deviation 1.56
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 6 Months	6.13 Fruit and Vegetable Servings per Day Standard Deviation 1.55

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Deaf Weight Wise Intervention Partner Site Implementation n=58 Participants The DWW study team worked with community partner organizations to train them to implement DWW at their own sites. The goal was to disseminate DWW broadly to Deaf communities. Working with partner organizations, the study team adapted DWW and supported implementation at various sites in central and western NY. The study team conducted an implementation-effectiveness Type 3 research design to plan, execute, and evaluate in collaboration with partners. Through the process, the study team evaluated whether DWW was implemented and whether it was delivered as intended.
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 18 Months	5.83 Fruit and Vegetable Servings per Day Standard Deviation 1.32
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 Baseline	5.62 Fruit and Vegetable Servings per Day Standard Deviation 1.57

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Deaf Weight Wise Intervention Partner Site Implementation n=57 Participants The DWW study team worked with community partner organizations to train them to implement DWW at their own sites. The goal was to disseminate DWW broadly to Deaf communities. Working with partner organizations, the study team adapted DWW and supported implementation at various sites in central and western NY. The study team conducted an implementation-effectiveness Type 3 research design to plan, execute, and evaluate in collaboration with partners. Through the process, the study team evaluated whether DWW was implemented and whether it was delivered as intended.
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	1611.43 Score on a scale Standard Deviation 1588.29
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) 6 Months	2460.79 Score on a scale Standard Deviation 1965.77

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Deaf Weight Wise Intervention Partner Site Implementation n=50 Participants The DWW study team worked with community partner organizations to train them to implement DWW at their own sites. The goal was to disseminate DWW broadly to Deaf communities. Working with partner organizations, the study team adapted DWW and supported implementation at various sites in central and western NY. The study team conducted an implementation-effectiveness Type 3 research design to plan, execute, and evaluate in collaboration with partners. Through the process, the study team evaluated whether DWW was implemented and whether it was delivered as intended.
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	1409.73 Score on a scale Standard Deviation 1481.73
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) 18 Months	2187.14 Score on a scale Standard Deviation 2527.10

SECONDARY outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	Deaf Weight Wise Intervention Partner Site Implementation n=63 Participants The DWW study team worked with community partner organizations to train them to implement DWW at their own sites. The goal was to disseminate DWW broadly to Deaf communities. Working with partner organizations, the study team adapted DWW and supported implementation at various sites in central and western NY. The study team conducted an implementation-effectiveness Type 3 research design to plan, execute, and evaluate in collaboration with partners. Through the process, the study team evaluated whether DWW was implemented and whether it was delivered as intended.
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 6 Months	-0.04 percentage of baseline weight Standard Deviation 0.05
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 Baseline	0.00 percentage of baseline weight Standard Deviation 0.00

SECONDARY outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	Deaf Weight Wise Intervention Partner Site Implementation n=56 Participants The DWW study team worked with community partner organizations to train them to implement DWW at their own sites. The goal was to disseminate DWW broadly to Deaf communities. Working with partner organizations, the study team adapted DWW and supported implementation at various sites in central and western NY. The study team conducted an implementation-effectiveness Type 3 research design to plan, execute, and evaluate in collaboration with partners. Through the process, the study team evaluated whether DWW was implemented and whether it was delivered as intended.
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 Baseline	0.00 percentage of baseline weight Standard Deviation 0.00
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 18 Months	-0.04 percentage of baseline weight Standard Deviation 0.06

Adverse Events

Behavioral: Deaf Weight Wise Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven Barnett, PhD

National Center for Deaf Health Research

Phone: 585-506-9484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place