NCT03092960

The HOMBRE Trial: Comparing Two Innovative Approaches to Reduce Chronic Disease Risk Among Latino Men

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 424 (actual)
• Sponsor: Palo Alto Medical Foundation · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study is a comparative effectiveness trial where obese Latino men will receive, by random assignment, the HOMBRE intervention or a minimal intensity intervention. The study is designed to test whether a flexible lifestyle program with choices for program engagement will lead to better health outcomes, compared to a minimal intensity self-directed lifestyle program. If proven successful, this study has the potential to significantly impact health outcomes that matter to Latino men through the innovative design of lifestyle interventions to prevent chronic disease.

Conditions

• Obesity
• Metabolic Syndrome
• Lifestyle Intervention
• Pre Diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-04-03
• Primary completion: 2020-05-31
• Completion: 2020-05-31
• First posted: 2017-03-28
• Last updated: 2021-11-17
• Results posted: 2021-11-17

Locations

1 site across 1 country: United States