Promoting Successful Weight Loss in Primary Care in Louisiana
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 20 - 75 |
| Updated: | 3/23/2019 |
| Start Date: | April 2016 |
| End Date: | December 2019 |
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.
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.
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.
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.
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
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