Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL)

Pennington Biomedical Research Center

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Lifestyle Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT02561221

PBRC 2015-052

PCORI#OB-1402-10977 (Other Grant/Funding Number)

Details and patient eligibility

About

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 clinics received a behavioral intervention delivered in a primary care setting and half of the clinics received usual care.

Full description

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 were randomized to either 1) intervention or 2) usual care. The sample includes 803 patients with obesity (BMI 30-50 kg/m2) (18 clinics, median of 40.5 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 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 intervention arm received 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, 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 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 were assessed on primary and secondary outcome measures at baseline, and at 6, 12, 18 and 24 months of intervention.

Enrollment: 803 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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803 participants in 2 patient groups

Lifestyle Counseling

Experimental group

Description:

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.

Treatment:

Behavioral: Lifestyle Counseling

Usual Care

No Intervention group

Description:

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.