Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-01-04 @ 4:49 PM
Study NCT ID:
NCT03092960
Status:
COMPLETED
Last Update Posted:
2021-11-17
First Post:
2017-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The HOMBRE Trial: Comparing Two Innovative Approaches to Reduce Chronic Disease Risk Among Latino Men
Sponsor:
Palo Alto Medical Foundation
Organization:
Study Overview
Official Title:
The HOMBRE Trial: Comparing Two Innovative Approaches to Reduce Chronic Disease Risk Among Latino Men
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOMBRE
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: