NCT05523375

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 352 (actual)
• Sponsor: Pennington Biomedical Research Center · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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 medical record (EMR).

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.

Conditions

• Obesity
• Diabetes Mellitus, Type 2
• PreDiabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-29
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2022-08-31
• Last updated: 2025-03-17

Locations

1 site across 1 country: United States