Promoting Successful Weight Loss in Primary Care in Louisiana

NCT02561221 | Completed Results DMC

• 2 other identifiers: PBRC 2015-052PCORI#OB-1402-10977
• Study Type: interventional
• Target: 803
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

primary care; pragmatic trial; weight loss; overweight; diet; physical activity; PCORI

Outcome Measures

Primary Outcomes (1)

• Body Weight (Percent Change)

  Body weight is measured in light indoor clothes.

  Percent (%) Change from Baseline to Month 24

Secondary Outcomes (23)

• Waist Circumference

  Change from Baseline to Month 24

• Systolic Blood Pressure

  Change from Baseline to Month 24

• Fasting Plasma Glucose

  Change from Baseline to Month 24

• Total Cholesterol

  Change from Baseline to Month 24

• Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function

  Change from Baseline to Month 24

Study Arms (2)

Lifestyle Counseling

EXPERIMENTAL

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.

Behavioral: Lifestyle Counseling

Usual Care

NO INTERVENTION

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.

Interventions

Lifestyle Counseling BEHAVIORAL

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.

Lifestyle Counseling

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Louisiana State University Health Sciences Center Shreveport: collaborator
• Tulane University: collaborator
• Ochsner Health System: collaborator
• Louisiana State University Health Sciences Center in New Orleans: collaborator
• Xavier University of Louisiana.: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (12)

• 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.

  PMID: 29408562 RESULT

• 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.

  PMID: 31248113 RESULT

• 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.

  PMID: 32877581 RESULT

• 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.

  PMID: 33557578 RESULT

• 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.

  PMID: 35762659 RESULT

• 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.

  PMID: 35523955 RESULT

• 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.

  PMID: 35412010 RESULT

• 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.

  PMID: 34714976 RESULT

• 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.

  PMID: 36702913 RESULT

• 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.

  PMID: 39429541 DERIVED

• 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.

  PMID: 37551762 DERIVED

• 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.

  PMID: 37528391 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss; Overweight; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior

Results Point of Contact

• Title: Dr. Peter T. Katzmarzyk, Associate Executive Director of Population and Public Health Sciences
• Organization: Pennington Biomedical Research Center

doctors@pbrc.edu

225-763-2536

Study Officials

• Peter T Katzmarzyk, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Executive Director for Population and Public Health Sciences

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: September 25, 2015
• Study Start: April 1, 2016
• Primary Completion: September 6, 2019
• Study Completion: September 6, 2019
• Last Updated: August 1, 2023
• Results First Posted: December 10, 2020

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available upon reasonable request to the Principal Investigator 1 year after the publication of the Primary Outcomes manuscript.
• Access Criteria: Access to the data must be approved by the PROPEL Publications Committee.

Locations

US (1)