Promoting Successful Weight Loss in Primary Care in Louisiana Using Information Technology (PROPEL-IT)

Pennington Biomedical Research Center

Status: Active, not recruiting

Conditions: Obesity; Diabetes Mellitus, Type 2; PreDiabetes

Treatments: Behavioral: Intensive Lifestyle Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05523375

PBRC 2021-072

P50MD017338 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 352 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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352 participants in 2 patient groups

Intensive Lifestyle Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Intensive Lifestyle Intervention

Usual Care

No Intervention group

Description:

Patients in the usual care arm will receive their normal, usual care from their primary care team.