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ObesityPROPEL-ITNCT05523375

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

A study testing Intensive Lifestyle Intervention in people with Obesity and Diabetes Mellitus, Type 2, run by Pennington Biomedical Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Obesity, Diabetes Mellitus, Type 2, PreDiabetes
What is being tested?
Intensive Lifestyle Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
352 participants
Where
1 siteUnited States
Study dates
29 Aug 2022to 28 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

Other trials in United States

About this study

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).

Read the 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.

Being tested
Intensive Lifestyle Intervention
Medical subject headings
Obesity, Diabetes Mellitus, Type 2, Prediabetic State

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive Lifestyle InterventionBehavioural

    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.

Study groups in NCT05523375
Study groupRoleWhat they receive
Intensive Lifestyle InterventionExperimentalThe 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.
Receives: Behavioral: Intensive Lifestyle Intervention
Usual CareNo interventionPatients in the usual care arm will receive their normal, usual care from their primary care team.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body weight (Percent Change)

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

    Measured: Percent (%) Change from Baseline to Month 24

Secondary outcomes (14)

  1. Body weight (kg)

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

    Measured: Change in kg from Baseline to Month 24

  2. Systolic Blood Pressure

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

    Measured: Change from Baseline to Month 24

  3. Diastolic Blood Pressure

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

    Measured: Change from Baseline to Month 24

  4. HbA1c

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

    Measured: Change from Baseline to Month 24

  5. Total Cholesterol

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

    Measured: Change from Baseline to Month 24

  6. High-density Lipoprotein (HDL) Cholesterol

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

    Measured: Change from Baseline to Month 24

  7. Triglycerides

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

    Measured: Change from Baseline to Month 24

  8. Low-density Lipoprotein (LDL) cholesterol

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

    Measured: Change from Baseline to Month 24

  9. Physical Activity

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

    Measured: Change from Baseline to Month 24

  10. Dietary Intake

    Dietary intake is measured using National Cancer Institute Dietary Screeners.

    Measured: Change from Baseline to Month 24

  11. 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.

    Measured: Change from Baseline to Month 24

  12. 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.

    Measured: Change from Baseline to Month 24

  13. 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.

    Measured: Change from Baseline to Month 24

  14. 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.

    Measured: Change from Baseline to Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2022
  2. Study start29 Aug 2022
  3. Primary completion28 Feb 2026
  4. Study completion28 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
352 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05523375
Sponsor's protocol ID
PBRC 2021-072
Other IDs
P50MD017338
Acronym
PROPEL-IT
Status last verified
Sep 2026
First submitted
29 Aug 2022
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 39756673

Questions about this trial

What is this clinical trial studying?

A study testing Intensive Lifestyle Intervention in people with Obesity and Diabetes Mellitus, Type 2, run by Pennington Biomedical Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body weight (Percent Change) (time frame: Percent (%) Change from Baseline to Month 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05523375, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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