Study Information
Locations
Not Specified
Clinical Trial FAQs
Information for patients and study volunteers, including frequently asked questions.
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
Improving the Outcomes of Older Adults with Psychosocial Vulnerability Undergoing Major Surgery.
Dr. Dillon will lead the qualitative research--data collection and analysis.
Investigator: External PI, Principal Investigator
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
Suicidality and Major Depressive Disorder: Examining Screening, Detection and Follow-up Care Within a Large Multispecialty Healthcare System
To examine suicidality screening and its impact on suicide attempts and patient care, including implementation of standardized inpatient suicidality screening.
Investigator: Kristen M.J. Azar, R.N., BSN, MSN/MPH
Major Depressive Disorder
Purpose is to use EHR to understand the management of major depressive disorder in a large healthcare system, to incorporate pt-reported data in care workflow.
Investigator: Kristen M.J. Azar, R.N., BSN, MSN/MPH
Severe Mental Illness and Patterns of Emergency Department Utilization
Purpose is to provide descriptive info for improving health outcomes by identifying a subgroup of high-frequency ER patients who may have severe mental illness.
Investigator: Kristen M.J. Azar, R.N., BSN, MSN/MPH
Engaging Self-Regulation Targets to Understand the Mechanisms of Behavior Change and Improve Mood and Weight Outcomes
Goal: To identify, validate and refine assays to measure self-regulation targets, and to engage these targets to optimize behavioral tx of obesity & depression.
Investigator: 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
HCSRN Mental Health Research Network
Consortium focuses on improving individual and population mental health through research, under auspices of Health Care Systems Research Network.
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.
Pilot Program to Expand Behavioral Health Care for Adolescents Within Palo Alto Medical Foundation and Mills-Peninsula Health Services
This is a 5-year program to implement and evaluate integration of behavioral health into PAMF primary care settings, focusing on adolescents.
Investigator: External PI, Principal Investigator