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)
Related Studies
Stupski Serious Illness Program Evaluation
Evaluate palliative care projects at seven healthcare organizations in the SF Bay Area.
Investigator: Sylvia Sudat, PhD
The Impact of Smoking, Comorbidities, and Race/Ethnicity on COVID-19 Infection and Disease Severity
Using EHR from a large healthcare system in Northern CA, we will study the impact of smoking, comorbidities, race on COVID-19 infection and disease severity.
Investigator: Jiang Li, Ph.D., MPH
Statin Use and Risk Prediction of Atherosclerotic Cardiovascular Disease in Minority Subgroups (SURPASS) Study
Overall goal of this study is to address gaps in knowledge about CVD prediction and treatment in understudied racial/ethnic minority populations.
Investigators: Jiang Li, Ph.D., MPH, External PI, Principal Investigator
Prevalence, Treatment and Outcomes of Asian Subgroups with Coronary Artery Disease in the U.S.
Fill impt gaps in knowledge regarding CAD health disparities across Asian subgroup populations.
Investigators: Jiang Li, Ph.D., MPH, External PI, Principal Investigator
Cardiovascular Disease Among Asians and Pacific Islanders (CASPER)
Examine: CVD prevalence & outcomes among Asians and Pacific Islanders; demographic, clinical, psychosocial factors to explain prevalence & outcomes differences.
Investigators: External PI, Principal Investigator, Jiang Li, Ph.D., MPH
Advance Care Planning Practices in Caring for Vulnerable Elders with Multiple Chronic Conditions
To examine the impact of the palliative care program on the patterns of ACP documentation in EHR of patients with multiple chronic conditions.
Culturally Adapted DPP [Diabetes Prevention Program] Intervention for Mexican Americans in Primary Care: An RCT [randomized controlled trial]
Develop a culturally and linguistically adapted, technology-supported lifestyle intervention for diabetes prevention for Spanish-speaking Mexican Americans.
Research Aimed at Improving Both Mood and Weight (RAINBOW)
Evaluate effectiveness of integrated behavioral weight loss program and stepped care for depression in primary care setting.
International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)
To determine whether a strategy of early cardiac catheterization reduces incidence of the composite of cardiovascular death or nonfatal myocardial infarction.
Investigator: Bob S. Hu, M.D.
Integrated Examination of Myocardial Ischemia with Magnetic Resonance
This study aims to develop & evaluate a comprehensive integrated system of new MRI components for evaluating patients with inadequate blood supply to the heart.
Investigator: Bob S. Hu, M.D.