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

• ClinicalTrials.gov Identifier: NCT05523375
• Recruitment Status: Active, not recruiting
• First Posted: August 31, 2022
• Last Update Posted: February 20, 2024
• Sponsor: Pennington Biomedical Research Center
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); University of Alabama at Birmingham; Ochsner Health System
• Information provided by (Responsible Party): Peter T. Katzmarzyk, Pennington Biomedical Research Center

Tracking Information

• First Submitted Date: August 29, 2022
• First Posted Date: August 31, 2022
• Last Update Posted Date: February 20, 2024
• Actual Study Start Date: August 29, 2022
• Estimated Primary Completion Date: March 31, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 29, 2022)

Body weight (Percent Change) [ Time Frame: Percent (%) Change from Baseline to Month 24 ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 8, 2022)

• Body weight (kg) [ Time Frame: Change in kg from Baseline to Month 24 ]
  Body weight is measured in light indoor clothes and is obtained from the electronic medical record.
• Systolic Blood Pressure [ Time Frame: Change from Baseline to Month 24 ]
  Resting systolic blood pressure is measured and is obtained from the electronic medical record.
• Diastolic Blood Pressure [ Time Frame: Change from Baseline to Month 24 ]
  Resting diastolic blood pressure is measured and is obtained from the electronic medical record.
• HbA1c [ Time Frame: Change from Baseline to Month 24 ]
  HbA1c levels are assayed and are obtained from the electronic medical record.
• Total Cholesterol [ Time Frame: Change from Baseline to Month 24 ]
  Total cholesterol levels are assayed and are obtained from the electronic medical record.
• High-density Lipoprotein (HDL) Cholesterol [ Time Frame: Change from Baseline to Month 24 ]
  HDL cholesterol levels are assayed and are obtained from the electronic medical record.
• Triglycerides [ Time Frame: Change from Baseline to Month 24 ]
  Triglyceride levels are assayed and are obtained from the electronic medical record.
• Low-density Lipoprotein (LDL) cholesterol [ Time Frame: Change from Baseline to Month 24 ]
  LDL cholesterol levels are estimated using the Friedewald equation and are obtained from the electronic medical record.
• Physical Activity [ Time Frame: Change from Baseline to Month 24 ]
  Physical activity is measured using the International Physical Activity Questionnaire-SF questionnaire.
• Dietary Intake [ Time Frame: Change from Baseline to Month 24 ]
  Dietary intake is measured using National Cancer Institute Dietary Screeners.
• Impact of Weight on Quality of Life-Lite-Clinical Trials Questionnaire [ Time Frame: Change from Baseline to Month 24 ]
  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.
• EuroQol-5 Dimension Questionnaire [ Time Frame: Change from Baseline to Month 24 ]
  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.
• Health Care Utilization Questionnaire [ Time Frame: Change from Baseline to Month 24 ]
  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.
• Perceived Stress Scale-4 Questionnaire [ Time Frame: Change from Baseline to Month 24 ]
  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.

Original Secondary Outcome Measures (submitted: August 29, 2022)

• Body weight (kg) [ Time Frame: Change in kg from Baseline to Month 24 ]
  Body weight is measured in light indoor clothes and is obtained from the electronic medical record.
• Systolic Blood Pressure [ Time Frame: Change from Baseline to Month 24 ]
  Resting systolic blood pressure is measured and is obtained from the electronic medical record.
• Diastolic Blood Pressure [ Time Frame: Change from Baseline to Month 24 ]
  Resting diastolic blood pressure is measured and is obtained from the electronic medical record.
• HbA1c [ Time Frame: Change from Baseline to Month 24 ]
  HbA1c levels are assayed and are obtained from the electronic medical record.
• Total Cholesterol [ Time Frame: Change from Baseline to Month 24 ]
  Total cholesterol levels are assayed and are obtained from the electronic medical record.
• High-density Lipoprotein (HDL) Cholesterol [ Time Frame: Change from Baseline to Month 24 ]
  HDL cholesterol levels are assayed and are obtained from the electronic medical record.
• Triglycerides [ Time Frame: Change from Baseline to Month 24 ]
  Triglyceride levels are assayed and are obtained from the electronic medical record.
• Low-density Lipoprotein (LDL) cholesterol [ Time Frame: Change from Baseline to Month 24 ]
  LDL cholesterol levels are estimated using the Friedewald equation and are obtained from the electronic medical record.
• Physical Activity [ Time Frame: Change from Baseline to Month 24 ]
  Physical activity is measured using the International Physical Activity Questionnaire-SF questionnaire.
• Dietary Intake [ Time Frame: Change from Baseline to Month 24 ]
  Dietary intake is measured using National Cancer Institute Dietary Screeners.
• Obesity-related Quality of Life [ Time Frame: Change from Baseline to Month 24 ]
  Obesity-related quality of life is measured using the Impact of Weight on Quality of Life- Lite-Clinical Trials questionnaire.
• Health-related Quality of Life [ Time Frame: Change from Baseline to Month 24 ]
  Health-related quality of life is measured using the EuroQol-5 Dimension (EQ-5D-5L) questionnaire.
• Health Care Utilization [ Time Frame: Change from Baseline to Month 24 ]
  Health care utilization is measured using a brief 4-item questionnaire.
• Perceived Stress [ Time Frame: Change from Baseline to Month 24 ]
  Perceived stress is measured using the Perceived Stress Scale 4 (PSS-4) questionnaire.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Obesity
• Diabetes Mellitus, Type 2
• PreDiabetes

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.

Study Arms

• Experimental: 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.
  Intervention: Behavioral: Intensive Lifestyle Intervention
• No Intervention: Usual Care
  Patients in the usual care arm will receive their normal, usual care from their primary care team.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: August 29, 2022): 352
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 31, 2026
• Estimated Primary Completion Date: March 31, 2026 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05523375
• Other Study ID Numbers: PBRC 2021-072; P50MD017338 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: A de-identified individual-level dataset will be made available to researchers making a reasonable request and upon approval of the PROPEL-IT Publications Committee. Data will be made available 1 year after publication of the primary outcomes manuscript.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Time Frame: Data will be made available upon reasonable request to the Principal Investigator 1 year after the publication of the Primary Outcomes manuscript for up to 5 years.
• Access Criteria: Access to the data must be approved by the PROPEL-IT Publications Committee.

• Current Responsible Party: Peter T. Katzmarzyk, Pennington Biomedical Research Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Pennington Biomedical Research Center
• Original Study Sponsor: Same as current

Collaborators

• National Institute on Minority Health and Health Disparities (NIMHD)
• University of Alabama at Birmingham
• Ochsner Health System

Investigators

• Principal Investigator: Peter T Katzmarzyk, PhD; Pennington Biomedical Research Center

• PRS Account: Pennington Biomedical Research Center
• Verification Date: February 2024