HOMBRE Trial: Comparing Two Innovative Approaches to Reduce Chronic Disease Risk Among Latino Men
- Principal Investigator
- Ma, Jun
- Start Date
- End Date
This study has high potential to significantly impact health outcomes and to contribute to the elimination of health disparities by focusing on Latino men, a demographically important group that has been previously marginalized from research.
Obesity is a major contributor to the leading causes of death among all men, and Latino men have the highest rate of obesity among men in the United States (39 percent among Latino men vs. 34 percent among non-Latino white men).
Latino men bear a disproportionate chronic disease burden attributable to excess weight.
Behavioral lifestyle interventions that promote sustained, modest weight loss (5–10 percent) are recommended for obese adults for primary prevention of chronic disease. However, evidence for how best to deliver behavioral weight loss interventions is based largely on research conducted in non-Latino white women. Racial/ethnic minority men, such as Latinos, represent less than 4 percent of participants in behavioral weight loss intervention trials in the United States.
In this study, eligible men (n=424) will be enrolled over 12 months and receive, by random assignment, the HOMBRE intervention or a minimal intensity intervention.
HOMBRE stands for Hombres con Opciones para Mejorar el Bienestar y bajar el Riesgo de Enfermedades crónicas, which translates as “Men with choices to improve well-being and decrease chronic disease risk."
HOMBRE offers a package of flexible delivery options that engages Latino men in a culturally tailored 12-month behavioral intervention based on the evidence-based Group Lifestyle Balance intervention, which is available in Spanish. A trained lifestyle coach will meet with participants to facilitate an informed choice of delivery modalities: 1) individual approach via videos, 2) online virtual groups, or 3) in-person groups.
The goal is to offer Latino men a choice in delivery modality for how they engage with the material and to determine whether this pragmatic, patient-centered intervention is more effective than a single-modality, minimal-intensity intervention whose effectiveness relative to usual care was previously demonstrated.
Percentage of participants maintaining clinically significant weight loss (≥5 percent) at 18 months will be the primary outcome, given its relevance for patients, providers, and healthcare systems. We will conduct a detailed process evaluation using mixed methods to examine HOMBRE’s potential for translation and sustainability.
PCORI to Stanford University School of Medicine, which has subcontracted to the University of Illinois at Chicago
Rosas LG, Lv N, Azar KMJ, Xiao L, Hooker SP, Lewis MA, Zavella P, Venditti EM, Ma J. HOMBRE: A randomized controlled trial to compare two approaches to weight loss for overweight and obese Latino men (Hombres con Opciones para Mejorar el Bienestar y bajar el Riesgo de Enfermedades crónicas; men with choices to improve well-being and decrease chronic disease risk). Contemp Clin Trials. 2018 May;68:23-34. doi: 10.1016/j.cct.2018.02.019.