Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
NCT Number: NCT05523375
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 active but is not currently recruiting participants.
40 year–70 year
All sexes
Interventional
Not applicable
Baton Rouge, Louisiana, 70808, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: Change from Baseline to Month 24
Resting systolic blood pressure is measured and is obtained from the electronic medical record.
Time frame: Change from Baseline to Month 24
Resting diastolic blood pressure is measured and is obtained from the electronic medical record.
Time frame: Change from Baseline to Month 24
HbA1c levels are assayed and are obtained from the electronic medical record.
Time frame: Change from Baseline to Month 24
Total cholesterol levels are assayed and are obtained from the electronic medical record.
Time frame: Change from Baseline to Month 24
HDL cholesterol levels are assayed and are obtained from the electronic medical record.
Time frame: Change from Baseline to Month 24
Triglyceride levels are assayed and are obtained from the electronic medical record.
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.
Time frame: Change from Baseline to Month 24
Physical activity is measured using the International Physical Activity Questionnaire-SF questionnaire.
Time frame: Change from Baseline to Month 24
Dietary intake is measured using National Cancer Institute Dietary Screeners.
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.
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.
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.
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.
Pennington Biomedical Research Center
Other
Acronym: PROPEL-IT
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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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