CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 424 enrolled
Drug / intervention
Minimal intensity intervention +1 morebehavioral
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Latino of any race
  • ✓BMI greater than 27 kg/m²
  • ✓One or more metabolic syndrome component (high triglycerides, blood pressure, fasting glucose, central obesity, or low HDL cholesterol)
  • ✓Primary care physician approval of patient study contact
Key exclusion· 9
  • ✕Previous diagnosis of diabetes or diabetes diagnosed through study screening (fasting glucose or A1c)
  • ✕Active cancer or cancer treated with radiation/chemotherapy within past 2 years (non-melanoma skin cancer allowed)
  • ✕Unable to walk without assistance of another person
  • ✕Severe medical comorbidities requiring aggressive treatment (stage 4+ renal disease, class III+ heart failure, unstable CAD, liver/renal failure)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT03092960N/ACompleted
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The HOMBRE Trial: Comparing Two Innovative Approaches to Reduce Chronic Disease Risk Among Latino Men

Palo Alto Medical Foundation·interventional·Posted Mar 28, 2017·Updated Nov 17, 2021

In Brief

A clinical study evaluating Minimal intensity intervention and HOMBRE for Obesity and 3 related conditions. Completed, enrolled 424 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Metabolic Syndrome, Lifestyle Intervention, Pre Diabetes
CountriesUnited States
CollaboratorsPatient-Centered Outcomes Research Institute, University of Illinois at Chicago, RTI International, University of Pittsburgh, Arizona State University, Stanford University

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 28, 2017
Enrollment StartApr 3, 2017
Primary CompletionMay 31, 2020
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 9.3 years ago

Interventions

Minimal intensity interventionbehavioral

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.

HOMBREbehavioral

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.