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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-29

Study Completion Date

2026-03-31

Brief Summary

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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).

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Detailed Description

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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

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Obesity Diabetes Mellitus, Type 2 PreDiabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intensive Lifestyle Intervention

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.

Group Type EXPERIMENTAL

Intensive Lifestyle Intervention

Intervention Type 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.

Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No