Promoting Successful Weight Loss in Primary Care in Louisiana
NCT ID: NCT02561221
Last Updated: 2023-08-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
803 participants
INTERVENTIONAL
2016-04-30
2019-09-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Lifestyle Counseling
Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.
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.
No interventions assigned to this group
Interventions
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Lifestyle Counseling
Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
75 Years
ALL
No
Sponsors
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Louisiana State University Health Sciences Center Shreveport
OTHER
Tulane University
OTHER
Ochsner Health System
OTHER
Louisiana State University Health Sciences Center in New Orleans
OTHER
Xavier University of Louisiana.
OTHER
Patient-Centered Outcomes Research Institute
OTHER
Pennington Biomedical Research Center
OTHER
Responsible Party
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Peter T. Katzmarzyk
Associate Executive Director for Population and Public Health Sciences
Principal Investigators
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Peter T Katzmarzyk, PhD
Role: PRINCIPAL_INVESTIGATOR
Pennington Biomedical Research Center
Locations
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Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Katzmarzyk PT, Mire EF, Horswell R, Chu ST, Zhang D, Martin CK, Newton RL, Apolzan JW, Price-Haywood EG, Fort D, Carton TW, Denstel KD; PROPEL Research Group. Four-year follow-up of weight loss maintenance using electronic medical record data: The PROPEL trial. Obes Sci Pract. 2024 Oct 19;10(5):e70017. doi: 10.1002/osp4.70017. eCollection 2024 Oct.
Hochsmann C, Martin CK, Apolzan JW, Dorling JL, Newton RL Jr, Denstel KD, Mire EF, Johnson WD, Zhang D, Arnold CL, Davis TC, Fonseca V, Thethi TK, Lavie CJ, Springgate B, Katzmarzyk PT; PROPEL Research Group. Initial weight loss and early intervention adherence predict long-term weight loss during the Promoting Successful Weight Loss in Primary Care in Louisiana lifestyle intervention. Obesity (Silver Spring). 2023 Sep;31(9):2272-2282. doi: 10.1002/oby.23854. Epub 2023 Aug 8.
Apolzan JW, Martin CK, Newton RL Jr, Myers CA, Arnold CL, Davis TC, Johnson WD, Zhang D, Hochsmann C, Fonseca VA, Denstel KD, Mire EF, Springgate BF, Lavie CJ, Katzmarzyk PT; PROPEL Research Group. Dietary intake during a pragmatic cluster-randomized weight loss trial in an underserved population in primary care. Nutr J. 2023 Aug 2;22(1):38. doi: 10.1186/s12937-023-00864-7.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PCORI#OB-1402-10977
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PBRC 2015-052
Identifier Type: -
Identifier Source: org_study_id
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