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Baton Rouge, Louisiana 70808


Purpose:

The primary aim of this trial is to develop and test the effectiveness of a 24 month, patient-centered, pragmatic and scalable obesity treatment program delivered within primary care, inclusive of an underserved population. Half of the participants will receive a behavioral intervention delivered in a primary care setting and half of the participants will receive usual care.


Study summary:

This study is a cluster-randomized, two-arm controlled trial in primary care settings. A total of 18 primary care clinics inclusive of low income populations with a high percentage of African Americans from urban and rural areas across Louisiana will be randomized to either 1) intervention or 2) usual care. The sample will include 800 obese (BMI 30-50 kg/m2) patients (18 clinics, 44 patients / clinic). The primary aim of this trial is to develop and test the effectiveness of a 24 month, patient-centered, pragmatic and scalable obesity treatment program delivered within primary care, inclusive of an underserved population. Patients in the intervention arm will attend weekly (15 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention will be delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the intervention arm will receive a series of webinars on obesity science to help them manage and treat obese patients. Patients assigned to the usual care arm will continue to interact with their Primary Care Practitioner according to their usual schedule, and will receive a series of newsletters on topics of interest, including importance of sleep for health, household money management, family coping skills, smoking cessation, etc. Primary Care Practitioners in the usual care arm will receive a webinar describing the current Centers for Medicare and Medicaid Services (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure will be sent to the Primary Care Practitioners each year. Patients in both arms will be assessed on primary and secondary outcome measures at baseline, and at 6, 12, 18 and 24 months of intervention.


Criteria:

Inclusion Criteria: - Age 20.0 - 75.0 years - BMI 30.0 - 50.0 kg/m2 - Able to provide written informed consent - Willing to change diet, physical activity and weight - Patient of a participating clinic - Able to participate in scheduled sessions Exclusion Criteria: - Currently participating in a weight loss program - Current use of weight loss medication or recent weight loss (>10 lbs in last 6 months) - Plans to move from the area within 2 years - Given birth within the past year, is currently pregnant or plans to become pregnant within 2 years - Past bariatric surgery or plans for bariatric surgery within 2 years - Current major depression - History of suicidal behavior or diagnosed eating disorder (bulimia, anorexia) - Hospitalization for mental disorder or substance abuse in the previous year - Active cancer (except prostate, skin and thyroid if approved by physician) - Serious arrhythmias or cardiomyopathy - Severe congestive heart failure - Stroke or heart attack in previous six months - Chronic Inflammatory conditions, including but not limited to severe arthritis, lupus, or inflammatory bowel disease(i.e. Crohn's disease or ulcerative colitis) - Disease that is life threatening or that can interfere with or be aggravated by exercise or weight loss - Discretion of primary care physician or principal investigator


NCT ID:

NCT02561221


Primary Contact:

Principal Investigator
Peter T Katzmarzyk, PhD
Pennington Biomedical Research Center


Backup Contact:

N/A


Location Contact:

Baton Rouge, Louisiana 70808
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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