Clinical Trials Logo

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05211596
Study type Interventional
Source University of Rochester
Status Active, not recruiting
Phase N/A
Start date February 2, 2022
Completion date July 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2