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| ID | Type | Description | Link |
|---|---|---|---|
| P50MD017338 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
| University of Alabama at Birmingham | OTHER |
| Ochsner Health System | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Lifestyle Intervention | Experimental | 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. |
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| Usual Care | No Intervention | Patients in the usual care arm will receive their normal, usual care from their primary care team. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter T Katzmarzyk, PhD | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39756673 | Derived | 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. |
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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.
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 to the data must be approved by the PROPEL-IT Publications Committee.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |