Clinical Trial FAQs
Information for patients and study volunteers, including frequently asked questions.
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.
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.
Patient-Centered Outcomes Research Institute (PCORI)
Engaging Self-Regulation Targets to Understand the Mechanisms of Behavior Change and Improve Mood and Weight Outcomes
Investigator: External PI, Principal Investigator
Investigator: Kristen M.J. Azar, R.N., BSN, MSN/MPH