Promoting Successful Weight Loss in Primary Care in Louisiana Using Information Technology
PROPEL-IT
2 other identifiers
interventional
352
1 country
1
Brief Summary
The primary aim is to test the effectiveness of an innovative 24-month pragmatic and scalable weight-loss centric approach using a collaborative care model that connects patients with a non-Primary Care Practitioner (PCP) health coach who delivers care remotely to patients through the patient portal of an electronic medical record (EMR).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Aug 2022
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2022
CompletedStudy Start
First participant enrolled
August 29, 2022
CompletedFirst Posted
Study publicly available on registry
August 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedMarch 17, 2025
March 1, 2025
3.6 years
August 29, 2022
March 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Body weight (Percent Change)
Body weight is measured in light indoor clothes and is obtained from the electronic medical record.
Percent (%) Change from Baseline to Month 24
Secondary Outcomes (14)
Body weight (kg)
Change in kg from Baseline to Month 24
Systolic Blood Pressure
Change from Baseline to Month 24
Diastolic Blood Pressure
Change from Baseline to Month 24
HbA1c
Change from Baseline to Month 24
Total Cholesterol
Change from Baseline to Month 24
- +9 more secondary outcomes
Study Arms (2)
Intensive Lifestyle Intervention
EXPERIMENTALThe intervention arm receives a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Obesity Guidelines, delivered remotely using eHealth technology, by trained health coaches embedded in the Digital Medicine Group in the Ochsner Health System. The intervention includes remote sessions with the health coach using evidence-based components such as the use of portion control and various behavioral strategies .Patients in the Intervention arm attend weekly sessions in the first six months, followed by monthly sessions for the remaining 18 months.
Usual Care
NO INTERVENTIONPatients in the usual care arm will receive their normal, usual care from their primary care team.
Interventions
Trained health coaches deliver 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
You may qualify if:
- years of age
- Self-identify as Black/African American
- Obesity (BMI 30.0-50.0 kg/m2)
- Type II diabetes (based on ICD-10 codes, fasting plasma glucose ≥126 mg/dL, HbA1c ≥6.5%, 2-h plasma glucose during 75-g Oral Glucose Tolerance Test (OGTT) ≥200 mg/dL, or a random plasma glucose ≥200 mg/dL in a patient with classic symptoms of hyperglycemia or hyperglycemic crisis) or pre-diabetes (based on ICD-10 codes, fasting glucose 100-125 mg/dL or HbA1c 5.7-6.4% or 2-h glucose during 75-g OGTT 140-199 mg/dL)
- Has an internet-connected device and is willing to use it for intervention delivery
- Patient in the Ochsner Health System with an active MyOchsner portal account, or willing to create one
- Acknowledgement from their Ochsner primary care practitioner that there are no known contraindications to the patient's participation
- Have weight measured at an Ochsner clinic within 4 weeks of screening
- Resident of Louisiana
- Be able to provide informed consent
- Willing to change diet and/or physical activity
You may not qualify if:
- Body weight ≥ 400 lbs.
- Current use of weight loss medication or recent weight loss (net loss \>10 lbs in the last six months)
- Currently participating in a structured weight loss program
- Plans to move from the area within 2 years
- Given birth within the past year, is currently pregnant or breastfeeding or plans to become pregnant within 2 years
- Past bariatric surgery or plans for bariatric surgery within 2 years
- Disease/condition that is life threatening or can interfere with or be aggravated by exercise or weight loss
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
Related Publications (1)
Katzmarzyk PT, Price-Haywood EG, Apolzan JW, Denstel KD, Drews KL, Farris E, Harden-Barrios J, Hearld LR, Mire EF, Martin CK, Newton RL, Pisu M. Improving weight loss and cardiometabolic risk in black patients with diabetes or pre-diabetes: Rationale and protocol for a digital medicine hybrid type 1 implementation trial. Contemp Clin Trials. 2025 Feb;149:107806. doi: 10.1016/j.cct.2024.107806. Epub 2025 Jan 3.
PMID: 39756673DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter T Katzmarzyk, PhD
Pennington Biomedical Research Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Executive Director for Population and Public Health
Study Record Dates
First Submitted
August 29, 2022
First Posted
August 31, 2022
Study Start
August 29, 2022
Primary Completion
March 31, 2026
Study Completion
March 31, 2026
Last Updated
March 17, 2025
Record last verified: 2025-03
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 for up to 5 years.
- Access Criteria
- Access to the data must be approved by the PROPEL-IT Publications Committee.
A de-identified individual-level dataset will be made available to researchers making a reasonable request and upon approval of the PROPEL-IT Publications Committee. Data will be made available 1 year after publication of the primary outcomes manuscript.