Description
This study (in English: Men with Choices to Improve Well-being and Decrease Chronic Disease Risk) is a pragmatic, comparative effectiveness trial where obese Latino men will receive, by random assignment, the HOMBRE intervention or a minimal intensity intervention. Eligible Latino men (n=424) with a BMI >30 kg/m2 (≥27.5 kg/m2 if Asian descent) and ≥1 metabolic syndrome component will be enrolled, randomized to HOMBRE (intervention; n=212) or the minimal intensity intervention (control; n=212), and followed until 18 months, with passive monitoring of BMI through the EHR through 24 months.
A trained lifestyle coach will meet with HOMBRE (intervention) participants to facilitate an informed choice of delivery modalities: (1) Individual approach via videos, (2) Online virtual groups, or (3) In-person groups. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
Specific aims:
Aim 1: Compare the effectiveness of HOMBRE with a minimal intensity intervention for sustaining clinically significant weight loss at 18 months.
Aim 2: Compare the effectiveness of HOMBRE with a minimal intensity intervention for improving cardiometabolic risk factors, health behaviors, and psychosocial well-being at 18 months.
Aim 3: Compare the other attributes of RE-AIM (reach, adoption, implementation, and maintenance) within the two interventions to inform rapid dissemination and long-term sustainability.
Other co-investigators are Jun Ma, M.D., Ph.D., University of Illinois at Chicago; Steven Hooker, Ph.D., Arizona State University; Megan Lewis, Ph.D., RTI Internal; Patricia Zavella, Ph.D., University of California, Santa Cruz; and Elizabeth Venditti, Ph.D., University of Pittsburgh.
A trained lifestyle coach will meet with HOMBRE (intervention) participants to facilitate an informed choice of delivery modalities: (1) Individual approach via videos, (2) Online virtual groups, or (3) In-person groups. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
Specific aims:
Aim 1: Compare the effectiveness of HOMBRE with a minimal intensity intervention for sustaining clinically significant weight loss at 18 months.
Aim 2: Compare the effectiveness of HOMBRE with a minimal intensity intervention for improving cardiometabolic risk factors, health behaviors, and psychosocial well-being at 18 months.
Aim 3: Compare the other attributes of RE-AIM (reach, adoption, implementation, and maintenance) within the two interventions to inform rapid dissemination and long-term sustainability.
Other co-investigators are Jun Ma, M.D., Ph.D., University of Illinois at Chicago; Steven Hooker, Ph.D., Arizona State University; Megan Lewis, Ph.D., RTI Internal; Patricia Zavella, Ph.D., University of California, Santa Cruz; and Elizabeth Venditti, Ph.D., University of Pittsburgh.
Co-Investigator(s)
Kristen M.J. Azar, R.N., BSN, MSN/MPH
Funder
Patient-Centered Outcomes Research Institute (PCORI)
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