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OpenTrials
Active, Not Recruiting

NCT Number: NCT05523375

Promoting Successful Weight Loss in Primary Care in Louisiana Using Information Technology

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive lifestyle intervention

Behavioral

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.

Primary outcomes

  1. Body weight (Percent Change)

    Time frame: Percent (%) Change from Baseline to Month 24

    Body weight is measured in light indoor clothes and is obtained from the electronic medical record.

Secondary outcomes

  1. Body weight (kg)

    Time frame: Change in kg from Baseline to Month 24

    Body weight is measured in light indoor clothes and is obtained from the electronic medical record.

  2. Systolic Blood Pressure

    Time frame: Change from Baseline to Month 24

    Resting systolic blood pressure is measured and is obtained from the electronic medical record.

  3. Diastolic Blood Pressure

    Time frame: Change from Baseline to Month 24

    Resting diastolic blood pressure is measured and is obtained from the electronic medical record.

  4. HbA1c

    Time frame: Change from Baseline to Month 24

    HbA1c levels are assayed and are obtained from the electronic medical record.

  5. Total Cholesterol

    Time frame: Change from Baseline to Month 24

    Total cholesterol levels are assayed and are obtained from the electronic medical record.

  6. High-density Lipoprotein (HDL) Cholesterol

    Time frame: Change from Baseline to Month 24

    HDL cholesterol levels are assayed and are obtained from the electronic medical record.

  7. Triglycerides

    Time frame: Change from Baseline to Month 24

    Triglyceride levels are assayed and are obtained from the electronic medical record.

  8. Low-density Lipoprotein (LDL) cholesterol

    Time frame: Change from Baseline to Month 24

    LDL cholesterol levels are estimated using the Friedewald equation and are obtained from the electronic medical record.

  9. Physical Activity

    Time frame: Change from Baseline to Month 24

    Physical activity is measured using the International Physical Activity Questionnaire-SF questionnaire.

  10. Dietary Intake

    Time frame: Change from Baseline to Month 24

    Dietary intake is measured using National Cancer Institute Dietary Screeners.

  11. Impact of Weight on Quality of Life-Lite-Clinical Trials Questionnaire

    Time frame: Change from Baseline to Month 24

    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.

  12. EuroQol-5 Dimension Questionnaire

    Time frame: Change from Baseline to Month 24

    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.

  13. Health Care Utilization Questionnaire

    Time frame: Change from Baseline to Month 24

    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.

  14. Perceived Stress Scale-4 Questionnaire

    Time frame: Change from Baseline to Month 24

    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.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)
  • Ochsner Health System
  • University of Alabama at Birmingham

Registry information

Acronym: PROPEL-IT

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 31, 2022
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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