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

Obesity Clinical Trial

— PROPEL-IT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05523375
• Other study ID #: PBRC 2021-072
• Secondary ID: P50MD017338
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 29, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: February 2024
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 352
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• PreDiabetes
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (4)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	National Institute on Minority Health and Health Disparities (NIMHD), Ochsner Health System, University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight (Percent Change)	Body weight is measured in light indoor clothes and is obtained from the electronic medical record.	Percent (%) Change from Baseline to Month 24
Secondary	Body weight (kg)	Body weight is measured in light indoor clothes and is obtained from the electronic medical record.	Change in kg from Baseline to Month 24
Secondary	Systolic Blood Pressure	Resting systolic blood pressure is measured and is obtained from the electronic medical record.	Change from Baseline to Month 24
Secondary	Diastolic Blood Pressure	Resting diastolic blood pressure is measured and is obtained from the electronic medical record.	Change from Baseline to Month 24
Secondary	HbA1c	HbA1c levels are assayed and are obtained from the electronic medical record.	Change from Baseline to Month 24
Secondary	Total Cholesterol	Total cholesterol levels are assayed and are obtained from the electronic medical record.	Change from Baseline to Month 24
Secondary	High-density Lipoprotein (HDL) Cholesterol	HDL cholesterol levels are assayed and are obtained from the electronic medical record.	Change from Baseline to Month 24
Secondary	Triglycerides	Triglyceride levels are assayed and are obtained from the electronic medical record.	Change from Baseline to Month 24
Secondary	Low-density Lipoprotein (LDL) cholesterol	LDL cholesterol levels are estimated using the Friedewald equation and are obtained from the electronic medical record.	Change from Baseline to Month 24
Secondary	Physical Activity	Physical activity is measured using the International Physical Activity Questionnaire-SF questionnaire.	Change from Baseline to Month 24
Secondary	Dietary Intake	Dietary intake is measured using National Cancer Institute Dietary Screeners.	Change from Baseline to Month 24
Secondary	Impact of Weight on Quality of Life-Lite-Clinical Trials Questionnaire	Items are scored 1-5 (never true to completely true). Scores are obtained on 3 composite scales (Physical, Physical Function, and Psychosocial), as well as total score. The raw composite score is calculated as the average of non-missing responses within each composite, then transforming to a 0-100 scale (worst to best). Composite scores and total score range from 0 to 100, where 100 represents higher levels of functioning.	Change from Baseline to Month 24
Secondary	EuroQol-5 Dimension Questionnaire	Each of 5 questions can have a response ranging from 1-5 (none to extreme). These are then concatenated into one of 3125 "health states" (i.e. 11231, 52454, etc.) An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension to create a value set. Lower scores indicate better health.	Change from Baseline to Month 24
Secondary	Health Care Utilization Questionnaire	Health care utilization is measured using a brief 4-item questionnaire with continuous responses (how many times did you go to the doctor, go to Emergency Room, stay overnight, # nights). Each question is analyzed separately.	Change from Baseline to Month 24
Secondary	Perceived Stress Scale-4 Questionnaire	The Perceived Stress Scale has 4 questions with responses ranging from 0-4 (Never to Very Often). Total (sum) score range is 0-16, with a higher score correlating to more stress.	Change from Baseline to Month 24