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

NCT05211596 | Completed Results

• 1 other identifier: STUDY00005784
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Deaf; American Sign Language

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  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

  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

  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)

  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)

  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

  Baseline to 6 Months (Pre- to Post-Intervention)

Study Arms (1)

Single Intervention Arm (Main Intervention)

OTHER

Main Intervention

Behavioral: Deaf Weight Wise intervention

Interventions

Deaf Weight Wise intervention BEHAVIORAL

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.

Also known as: DWW

Single Intervention Arm (Main Intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

National Center for Deaf Health Research, University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (2)

• 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.

  PMID: 19407810 BACKGROUND

• Barnett 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.

  PMID: 36890106 BACKGROUND

Related Links

• NCDHR Deaf Weight Wise research website

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Steven Barnett, PhD
• Organization: National Center for Deaf Health Research

steven_barnett@urmc.rochester.edu

585-506-9484

Study Officials

• Steven L Barnett, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 25, 2021
• First Posted: January 27, 2022
• Study Start: February 2, 2022
• Primary Completion: August 28, 2024
• Study Completion: August 28, 2024
• Last Updated: November 5, 2025
• Results First Posted: November 5, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: After completion of this study.
• Access Criteria: Access to deidentified data will only be granted if the interested researcher fully completes the NCDHR Data Use agreement Process.

Locations

US (1)