Clinical trial NCT02561221: Promoting Successful Weight Loss in Primary Care in Louisiana
Official title: Promoting Successful Weight Loss in Primary Care in Louisiana
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: primary care
pragmatic trial
weight loss
overweight
diet
physical activity
PCORI
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Louisiana State University Health Sciences Center Shreveport
name: Tulane University
name: Ochsner Health System
name: Louisiana State University Health Sciences Center in New Orleans
name: Xavier University of Louisiana.
name: Patient-Centered Outcomes Research Institute
First posted: 2015-09-25
Enrollment: 803
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Body Weight (Percent Change)
timeFrame: Percent (%) Change from Baseline to Month 24
Secondary outcomes:
measure: Waist Circumference
timeFrame: Change from Baseline to Month 24
measure: Systolic Blood Pressure
timeFrame: Change from Baseline to Month 24
measure: Fasting Plasma Glucose
timeFrame: Change from Baseline to Month 24
measure: Total Cholesterol
timeFrame: Change from Baseline to Month 24
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function
timeFrame: Change from Baseline to Month 24
measure: PROMIS-29 Anxiety
timeFrame: Change from Baseline to Month 24
measure: PROMIS-29 Depression
timeFrame: Change from Baseline to Month 24
measure: PROMIS-29 Fatigue
timeFrame: Change from Baseline to Month 24
measure: PROMIS-29 Sleep Disturbance
timeFrame: Change from Baseline to Month 24
measure: PROMIS-29 Social Functioning
timeFrame: Change from Baseline to Month 24
measure: PROMIS-29 Pain Interference
timeFrame: Change from Baseline to Month 24
measure: PROMIS-29 Pain Intensity
timeFrame: Change from Baseline to Month 24
measure: Impact of Weight on Quality of Life-Lite (IWQOL-L) Total Score
timeFrame: Change from Baseline to Month 24
measure: IWQOL-L Physical Function
timeFrame: Change from Baseline to Month 24
measure: IWQOL-L Self Esteem
timeFrame: Change from Baseline to Month 24
measure: IWQOL-L Sexual Life
timeFrame: Change from Baseline to Month 24
measure: IWQOL-L Public Distress
timeFrame: Change from Baseline to Month 24
measure: IWQOL-L Work/Daily Activity
timeFrame: Change from Baseline to Month 24
measure: Body Weight (Absolute Change)
timeFrame: Absolute (kg) Change from Baseline to Month 24
measure: Diastolic Blood Pressure
timeFrame: Change from Baseline to Month 24
measure: High-density Lipoprotein Cholesterol
timeFrame: Change from Baseline to Month 24
measure: Low-density Lipoprotein Cholesterol
timeFrame: Change from Baseline to Month 24
measure: Triglycerides
timeFrame: Change from Baseline to Month 24
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Peter T Katzmarzyk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katzmarzyk PT, Martin CK, Newton RL Jr, Apolzan JW, Arnold CL, Davis TC, Denstel KD, Mire EF, Thethi TK, Brantley PJ, Johnson WD, Fonseca V, Gugel J, Kennedy KB, Lavie CJ, Price-Haywood EG, Sarpong DF, Springgate B. Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL): Rationale, design and baseline characteristics. Contemp Clin Trials. 2018 Apr;67:1-10. doi: 10.1016/j.cct.2018.02.002. Epub 2018 Feb 8.
citation: Myers CA, Martin CK, Newton RL Jr, Apolzan JW, Arnold CL, Davis TC, Price-Haywood EG, Katzmarzyk PT. Cardiovascular Health, Adiposity, and Food Insecurity in an Underserved Population. Nutrients. 2019 Jun 19;11(6):1376. doi: 10.3390/nu11061376.
citation: Katzmarzyk PT, Martin CK, Newton RL Jr, Apolzan JW, Arnold CL, Davis TC, Price-Haywood EG, Denstel KD, Mire EF, Thethi TK, Brantley PJ, Johnson WD, Fonseca V, Gugel J, Kennedy KB, Lavie CJ, Sarpong DF, Springgate B. Weight Loss in Underserved Patients - A Cluster-Randomized Trial. N Engl J Med. 2020 Sep 3;383(10):909-918. doi: 10.1056/NEJMoa2007448.
citation: Hochsmann C, Dorling JL, Martin CK, Newton RL Jr, Apolzan JW, Myers CA, Denstel KD, Mire EF, Johnson WD, Zhang D, Arnold CL, Davis TC, Fonseca V, Lavie CJ, Price-Haywood EG, Katzmarzyk PT; PROPEL Research Group. Effects of a 2-Year Primary Care Lifestyle Intervention on Cardiometabolic Risk Factors: A Cluster-Randomized Trial. Circulation. 2021 Mar 23;143(12):1202-1214. doi: 10.1161/CIRCULATIONAHA.120.051328. Epub 2021 Feb 9.
citation: Dorling JL, Martin CK, Yu Q, Cao W, Hochsmann C, Apolzan JW, Newton RL, Denstel KD, Mire EF, Katzmarzyk PT. Mediators of weight change in underserved patients with obesity: exploratory analyses from the Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL) cluster-randomized trial. Am J Clin Nutr. 2022 Oct 6;116(4):1112-1122. doi: 10.1093/ajcn/nqac179.
citation: Katzmarzyk PT, Mire EF, Martin CK, Newton RL Jr, Apolzan JW, Price-Haywood EG, Denstel KD, Horswell R, Chu ST, Johnson WD; PROPEL Research Group. Comparison of weight loss data collected by research technicians versus electronic medical records: the PROPEL trial. Int J Obes (Lond). 2022 Aug;46(8):1456-1462. doi: 10.1038/s41366-022-01129-9. Epub 2022 May 6.
citation: Katzmarzyk PT, Denstel KD, Martin CK, Newton RL Jr, Apolzan JW, Mire EF, Horswell R, Johnson WD, Brown AW, Zhang D; PROPEL Research Group. Intraclass correlation coefficients for weight loss cluster randomized trials in primary care: The PROPEL trial. Clin Obes. 2022 Aug;12(4):e12524. doi: 10.1111/cob.12524. Epub 2022 Apr 12.
citation: Katzmarzyk PT, Apolzan JW, Gajewski B, Johnson WD, Martin CK, Newton RL Jr, Perri MG, VanWormer JJ, Befort CA. Weight loss in primary care: A pooled analysis of two pragmatic cluster-randomized trials. Obesity (Silver Spring). 2021 Dec;29(12):2044-2054. doi: 10.1002/oby.23292. Epub 2021 Oct 29.
citation: Katzmarzyk PT, Mire EF, Martin CK, Newton RL, Apolzan JW, Denstel KD, Johnson WD; PROPEL Research Group. Physical activity and weight loss in a pragmatic weight loss trial. Int J Obes (Lond). 2023 Mar;47(3):244-248. doi: 10.1038/s41366-023-01260-1. Epub 2023 Jan 26.