Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL): Rationale, design and baseline characteristics.

Peter T Katzmarzyk, Corby K Martin, Robert L Newton, John W Apolzan, Connie L Arnold, Terry C Davis, Kara D Denstel, Emily F Mire, Tina K Thethi, Phillip J Brantley, William D Johnson, Vivian Fonseca, Jonathan Gugel, Kathleen B Kennedy, Carl J Lavie, Eboni G Price-Haywood, Daniel F Sarpong, Benjamin Springgate

Journal: Contemporary clinical trials 2019;67():1-10

PMID: 29408562

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Abstract

UNLABELLED

Underserved and minority populations suffer from a disproportionately high prevalence of obesity and related comorbidities. Effective obesity treatment programs delivered in primary care that produce significant weight loss are currently lacking. The purpose of this trial is to test the effectiveness of a pragmatic, high intensity lifestyle-based obesity treatment program delivered within primary care among an underserved population. We hypothesize that, relative to patients who receive usual care, patients who receive a high-intensity, health literacy- and culturally-appropriate lifestyle intervention will have greater percent reductions in body weight over 24 months. Eighteen clinics (N = 803 patients) serving low income populations with a high proportion of African Americans in Louisiana were randomized to the intervention or usual car. Patients in the intervention participate in a high-intensity lifestyle program delivered by health coaches employed by an academic health center and embedded in the primary care clinics. The program consists of weekly (16 in-person/6 telephone) sessions in the first six months, followed by sessions held at least monthly for the remaining 18 months. Primary care practitioners in usual care receive information on weight management and the current Centers for Medicare and Medicaid Services reimbursement for obesity treatment. The primary outcome is percent weight loss at 24 months. Secondary outcomes include absolute 24-month changes in body weight, waist circumference, blood pressure, fasting glucose and lipids, health-related quality of life, and weight-related quality of life. The results will provide evidence on the effectiveness of implementing high-intensity lifestyle and obesity counseling in primary care settings among underserved populations.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier NCT02561221.

Address: Pennington Biomedical Research Center, Baton Rouge, LA, United States. Electronic address: [email protected].; Pennington Biomedical Research Center, Baton Rouge, LA, United States.; Department of Medicine, Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport, LA, United States.; Department of Medicine, Division of Endocrinology and Metabolism, Tulane University Health Sciences Center, School of Medicine, New Orleans, LA, United States; Southeast Louisiana Veterans Health Care System, United States.; Department of Medicine, Section of General Internal Medicine & Geriatrics, Tulane University Health Sciences Center, School of Medicine, New Orleans, LA, United States.; College of Pharmacy, Xavier University of Louisiana, New Orleans, LA, United States.; Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute, Ochsner Clinical School-The University of Queensland School of Medicine, New Orleans, LA, United States.; Ochsner Clinic Foundation, Center for Applied Health Services Research, New Orleans, LA, United States; Ochsner Clinical School, University of Queensland, New Orleans, LA, United States.; Department of Internal Medicine, Louisiana State University School of Medicine, New Orleans, LA, United States; Program in Health Policy and Systems Management, Louisiana State University School of Public Health, New Orleans, LA, United States.

DOI: 10.1016/j.cct.2018.02.002

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MeSH Terms: Black or African American, Body Mass Index, Cultural Competency, Efficiency, Organizational, Exercise, Female, Humans, Life Style, Louisiana, Male, Middle Aged, Obesity, Poverty, Primary Health Care, Quality of Life, Weight Reduction Programs