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

Study results available
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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
  • Stanford University

    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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03092960 on ClinicalTrials.gov