Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05523375

Active, not recruitingNot applicableInterventional

What this study is 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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age40 Years to 70 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Diabetes Mellitus, Type 2, PreDiabetes

Full registry 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

Treatments and study arms

Intensive Lifestyle Intervention

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.

Primary outcomes

Body weight (Percent Change)Percent (%) Change from Baseline to Month 24

Body weight is measured in light indoor clothes and is obtained from the electronic medical record.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Pennington Biomedical Research Center🇺🇸 Baton Rouge, Louisiana, United States