N/A N=85 Prevention

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

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

Bottom Line

View on ClinicalTrials.gov: NCT05211596 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2025

Primary outcome: Primary: Implementation of the Deaf Weight Wise Intervention at Partner Sites — 7 Partner Sites

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Deaf Weight Wise intervention (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Rochester
Primary completion: Aug 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Implementation of the Deaf Weight Wise Intervention at Partner Sites	7	—
PRIMARY Delivery of the Deaf Weight Wise Intervention As Intended	—	—
PRIMARY Number of Participants Who Did Not Receive the Intervention at Their Partner Site Because of Site Barriers and/or COVID Restrictions	85	—
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	5.70; 6.13	0.008 sig
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	5.62; 5.83	0.264
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)	1611.43; 2460.79	0.003 sig
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)	1409.73; 2187.14	0.054
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	0.00; -0.04	<0.001 sig
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	0.00; -0.04	<0.001 sig

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05211596). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.