Promoting Successful Weight Loss in Primary Care in Louisiana
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 803
- Locations
- 1
- Primary Endpoint
- Body Weight (Percent Change)
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Lifestyle Counseling
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.
Intervention: Lifestyle Counseling (Behavioral)
Usual Care
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.
Outcomes
Primary Outcomes
Body Weight (Percent Change)
Time Frame: Percent (%) Change from Baseline to Month 24
Body weight is measured in light indoor clothes.
Secondary Outcomes
- Body Weight (Absolute Change)(Absolute (kg) Change from Baseline to Month 24)
- Systolic Blood Pressure(Change from Baseline to Month 24)
- Total Cholesterol(Change from Baseline to Month 24)
- IWQOL-L Public Distress(Change from Baseline to Month 24)
- PROMIS-29 Depression(Change from Baseline to Month 24)
- PROMIS-29 Fatigue(Change from Baseline to Month 24)
- IWQOL-L Sexual Life(Change from Baseline to Month 24)
- Diastolic Blood Pressure(Change from Baseline to Month 24)
- Fasting Plasma Glucose(Change from Baseline to Month 24)
- PROMIS-29 Sleep Disturbance(Change from Baseline to Month 24)
- PROMIS-29 Pain Interference(Change from Baseline to Month 24)
- Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function(Change from Baseline to Month 24)
- PROMIS-29 Anxiety(Change from Baseline to Month 24)
- PROMIS-29 Pain Intensity(Change from Baseline to Month 24)
- Waist Circumference(Change from Baseline to Month 24)
- PROMIS-29 Social Functioning(Change from Baseline to Month 24)
- IWQOL-L Physical Function(Change from Baseline to Month 24)
- Triglycerides(Change from Baseline to Month 24)
- Impact of Weight on Quality of Life-Lite (IWQOL-L) Total Score(Change from Baseline to Month 24)
- IWQOL-L Self Esteem(Change from Baseline to Month 24)
- IWQOL-L Work/Daily Activity(Change from Baseline to Month 24)
- Low-density Lipoprotein Cholesterol(Change from Baseline to Month 24)
- High-density Lipoprotein Cholesterol(Change from Baseline to Month 24)
Investigators
Peter T. Katzmarzyk
Associate Executive Director for Population and Public Health Sciences
Pennington Biomedical Research Center