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
Quantifying 2D and 3D MRI Imaging For Improving MS Diagnosis, Treatment, And Clinical Care
Create a longitudinal proof-of-concept MS research database (MSClinQ) that can support clinical queries, and can be updated with new tx, dx tools, care options
Investigators: Xiaowei (Sherry) Yan, PhD, MS, J.B. Jones, PhD, MBA
Improving Cancer Care
Project will provide information about referrals to palliative care and way to enhance goals of care discussions for patients diagnosed with stage IV cancer.
Investigator: Su-Ying Liang, Ph.D.
Using Mobile Technology and Analytics to Track Outcomes in MS Patients
Develop an app to collect and transform pt-reported outcomes in MS for health care providers to improve care and support shared decision making.
Investigators: J.B. Jones, PhD, MBA, Xiaowei (Sherry) Yan, PhD, MS
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
Transforming Primary and Specialty Care for Inflammatory Bowel Disease
Use healthcare data to personalize the healthcare experience for people with inflammatory bowel disease.
Implementing Universal Lynch Syndrome Screening Across Multiple Healthcare Systems: Identifying Strategies to Facilitate and Maintain Programs in Different Organizations Contexts
To describe and explain variations in Lynch syndrome (LS) screening implementation across healthcare systems and create a toolkit for implementing LS screening.
Investigators: External PI, Principal Investigator, Monique de Bruin, M.D., MPH, Su-Ying Liang, Ph.D.
Lung Function Improvement After Bronchoscopic Lung Volume Reduction With Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE)
This study investigates the safety and effectiveness of the Pulmonx EBV for treating emphysema symptoms as compared to a standard medical therapy alone.
Investigator: Ganesh Krishna, M.D.
Using Electronic Health Records to Understand Pathways of Breast Cancer Screening and Care
To examine how EHR data can expand understanding of breast cancer pathways--screening to dx and tx.
Breast Cancer Chemoprevention in Primary Care at Geisinger
Identify PCPs’ awareness of breast cancer risk assessment and breast cancer chemoprevention knowledge, and identify perceived barriers and clinic solutions.
Investigators: External PI, Principal Investigator, Xiaowei (Sherry) Yan, PhD, MS
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