Clinical trial NCT05211596: Deaf Weight Wise: Community-engaged Implementation Research to Promote Healthy Lifestyle Change With Deaf American Sign Language Users
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Lifestyle
Overweight
Obesity
Cardiovascular Risks
Implementation Research
Keywords: Deaf
American Sign Language
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Site-level outcome: Implementation of the Deaf Weight Wise intervention at partner sites
timeFrame: Assessed at each site at 18 months after baseline enrollment of participants
measure: Site-level outcome: Percentage of Deaf Weight Wise intervention groups delivered as intended
timeFrame: Assessed at each site at 18 months after baseline enrollment of participants
Secondary outcomes:
measure: Participant-level outcome: Mean change from baseline to 6-months (post-intervention) in number of fruit and vegetable servings per day as measured by the Block fruit, vegetable, fiber screener
timeFrame: baseline and 6-months (pre and post intervention)
measure: Participant-level outcome: Mean change from baseline to 6-months (post-intervention) in physical activity as reported on the International Physical Activity Question (IPAQ)
timeFrame: baseline and 6-months (pre and post intervention)
measure: Participant-level outcome: Mean change from baseline to 6-months (post-intervention) in self-reported body weight, for participants with BMI above normal range
timeFrame: baseline and 6-months (pre and post intervention)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: National Center for Deaf Health Research, University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Steven L Barnett, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.