Promoting Successful Weight Loss in Primary Care in Louisiana Using Information Technology (PROPEL-IT)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Diabetes Mellitus, Type 2; PreDiabetes
• Intervention / Treatment: Behavioral: Intensive Lifestyle Intervention

Detailed Description

This study is a 24-month, two-arm, parallel controlled trial in a primary care setting. A total of 352 Black adults with obesity and type 2 diabetes or prediabetes will be randomized to either 1) intervention or 2) usual care. The intervention arm will receive 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 will include remote sessions with the health coach using evidence-based components such as the use of portion control and various behavioral strategies. Patients in the usual care arm will receive their normal, usual care from their primary care team. All patients will participate in the collection of patient-reported outcomes at baseline and approximately 6, 12, and 24 months.

• Study Type: Interventional
• Enrollment (Actual): 352
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 40-70 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive Lifestyle Intervention; The 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.	Behavioral: Intensive Lifestyle Intervention; 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.
No Intervention: Usual Care; Patients in the usual care arm will receive their normal, usual care from their primary care team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight (kg)	Body weight is measured in light indoor clothes and is obtained from the electronic medical record.	Change in kg from Baseline to Month 24
Systolic Blood Pressure	Resting systolic blood pressure is measured and is obtained from the electronic medical record.	Change from Baseline to Month 24
Diastolic Blood Pressure	Resting diastolic blood pressure is measured and is obtained from the electronic medical record.	Change from Baseline to Month 24
HbA1c	HbA1c levels are assayed and are obtained from the electronic medical record.	Change from Baseline to Month 24
Total Cholesterol	Total cholesterol levels are assayed and are obtained from the electronic medical record.	Change from Baseline to Month 24
High-density Lipoprotein (HDL) Cholesterol	HDL cholesterol levels are assayed and are obtained from the electronic medical record.	Change from Baseline to Month 24
Triglycerides	Triglyceride levels are assayed and are obtained from the electronic medical record.	Change from Baseline to Month 24
Low-density Lipoprotein (LDL) cholesterol	LDL cholesterol levels are estimated using the Friedewald equation and are obtained from the electronic medical record.	Change from Baseline to Month 24
Physical Activity	Physical activity is measured using the International Physical Activity Questionnaire-SF questionnaire.	Change from Baseline to Month 24
Dietary Intake	Dietary intake is measured using National Cancer Institute Dietary Screeners.	Change from Baseline to Month 24
Impact of Weight on Quality of Life-Lite-Clinical Trials Questionnaire	Items are scored 1-5 (never true to completely true). Scores are obtained on 3 composite scales (Physical, Physical Function, and Psychosocial), as well as total score. The raw composite score is calculated as the average of non-missing responses within each composite, then transforming to a 0-100 scale (worst to best). Composite scores and total score range from 0 to 100, where 100 represents higher levels of functioning.	Change from Baseline to Month 24
EuroQol-5 Dimension Questionnaire	Each of 5 questions can have a response ranging from 1-5 (none to extreme). These are then concatenated into one of 3125 "health states" (i.e. 11231, 52454, etc.) An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension to create a value set. Lower scores indicate better health.	Change from Baseline to Month 24
Health Care Utilization Questionnaire	Health care utilization is measured using a brief 4-item questionnaire with continuous responses (how many times did you go to the doctor, go to Emergency Room, stay overnight, # nights). Each question is analyzed separately.	Change from Baseline to Month 24
Perceived Stress Scale-4 Questionnaire	The Perceived Stress Scale has 4 questions with responses ranging from 0-4 (Never to Very Often). Total (sum) score range is 0-16, with a higher score correlating to more stress.	Change from Baseline to Month 24

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: University of Alabama at Birmingham; National Institute on Minority Health and Health Disparities (NIMHD); Ochsner Health System
• Investigators: Principal Investigator: Peter T Katzmarzyk, PhD, Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2022
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Body Weight; Body Weight Changes; Glucose Metabolism Disorders; Diabetes Mellitus; Weight Loss; Diabetes Mellitus, Type 2
• Other Study ID Numbers: PBRC 2021-072; P50MD017338 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Access to the data must be approved by the PROPEL-IT Publications Committee.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No