Clinical trial NCT05523375: Promoting Successful Weight Loss in Primary Care in Louisiana Using Information Technology
Official title: Promoting Successful Weight Loss in Primary Care in Louisiana Using Information Technology
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Diabetes Mellitus, Type 2
PreDiabetes
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: University of Alabama at Birmingham
name: Ochsner Health System
First posted: 2022-08-31
Enrollment: 352
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Body weight (Percent Change)
timeFrame: Percent (%) Change from Baseline to Month 24
Secondary outcomes:
measure: Body weight (kg)
timeFrame: Change in kg from Baseline to Month 24
measure: Systolic Blood Pressure
timeFrame: Change from Baseline to Month 24
measure: Diastolic Blood Pressure
timeFrame: Change from Baseline to Month 24
measure: HbA1c
timeFrame: Change from Baseline to Month 24
measure: Total Cholesterol
timeFrame: Change from Baseline to Month 24
measure: High-density Lipoprotein (HDL) Cholesterol
timeFrame: Change from Baseline to Month 24
measure: Triglycerides
timeFrame: Change from Baseline to Month 24
measure: Low-density Lipoprotein (LDL) cholesterol
timeFrame: Change from Baseline to Month 24
measure: Physical Activity
timeFrame: Change from Baseline to Month 24
measure: Dietary Intake
timeFrame: Change from Baseline to Month 24
measure: Impact of Weight on Quality of Life-Lite-Clinical Trials Questionnaire
timeFrame: Change from Baseline to Month 24
measure: EuroQol-5 Dimension Questionnaire
timeFrame: Change from Baseline to Month 24
measure: Health Care Utilization Questionnaire
timeFrame: Change from Baseline to Month 24
measure: Perceived Stress Scale-4 Questionnaire
timeFrame: Change from Baseline to Month 24
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Peter T Katzmarzyk, PhD
role: PRINCIPAL_INVESTIGATOR
References: