Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL)
Obesity
About this trial
This is an interventional treatment trial for Obesity focused on measuring primary care, pragmatic trial, weight loss, overweight, diet, physical activity, PCORI
Eligibility 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
Sites / Locations
- Pennington Biomedical Research Center
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Lifestyle Counseling
Usual Care
Patients in the Lifestyle Counseling Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity.
Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.