The HOMBRE Trial: Comparing Two Innovative Approaches to Reduce Chronic Disease Risk Among Latino Men
NCT03092960 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 424
Last updated 2021-11-17
Summary
The purpose of this study is to test a flexible lifestyle program designed to help Latino men make healthy lifestyle changes to lower their risk of developing diabetes and heart disease. The program is called HOMBRE (Hombres con Opciones para Mejorar el Bienestar y bajar el Riesgo de Enfermedades crónicas; English translation: Men with choices to improve well being and decrease chronic disease risk).
Conditions
- Obesity
- Metabolic Syndrome
- Lifestyle Intervention
- Pre Diabetes
Interventions
- BEHAVIORAL
-
Minimal intensity intervention
The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
- BEHAVIORAL
-
HOMBRE
HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
Sponsors & Collaborators
-
Patient-Centered Outcomes Research Institute
collaborator OTHER -
University of Illinois at Chicago
collaborator OTHER -
RTI International
collaborator OTHER -
University of Pittsburgh
collaborator OTHER -
Arizona State University
collaborator OTHER - collaborator OTHER
-
Palo Alto Medical Foundation
lead OTHER
Principal Investigators
-
Lisa Goldman Rosas, PhD, MPH · Stanford University
-
Kristen M Azar, RN, MSN, MPH · Sutter Health Research Development & Dissemination
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-04-03
- Primary Completion
- 2020-05-31
- Completion
- 2020-05-31
Countries
- United States
Study Locations
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