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

Primary Purpose

Obesity, Diabetes Mellitus, Type 2, PreDiabetes

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intensive Lifestyle Intervention

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Pennington Biomedical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intensive Lifestyle Intervention

Usual Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Body weight (Percent Change)

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

Secondary Outcome Measures

Body weight (kg)

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

Systolic Blood Pressure

Resting systolic blood pressure is measured and is obtained from the electronic medical record.

Diastolic Blood Pressure

Resting diastolic blood pressure is measured and is obtained from the electronic medical record.

HbA1c

HbA1c levels are assayed and are obtained from the electronic medical record.

Total Cholesterol

Total cholesterol levels are assayed and are obtained from the electronic medical record.

High-density Lipoprotein (HDL) Cholesterol

HDL cholesterol levels are assayed and are obtained from the electronic medical record.

Triglycerides

Triglyceride levels are assayed and are obtained from the electronic medical record.

Low-density Lipoprotein (LDL) cholesterol

LDL cholesterol levels are estimated using the Friedewald equation and are obtained from the electronic medical record.

Physical Activity

Physical activity is measured using the International Physical Activity Questionnaire-SF questionnaire.

Dietary Intake

Dietary intake is measured using National Cancer Institute Dietary Screeners.

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.

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.

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.

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.

Full Information

NCT ID

NCT05523375

First Posted

August 29, 2022

Last Updated

September 13, 2023

Sponsor

Pennington Biomedical Research Center

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05523375

Brief Title

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

Acronym

PROPEL-IT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 29, 2022 (Actual)

Primary Completion Date

March 31, 2026 (Anticipated)

Study Completion Date

March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Pennington Biomedical Research Center

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Diabetes Mellitus, Type 2, PreDiabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

352 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intensive Lifestyle Intervention

Arm Type

Experimental

Arm Description

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Intensive Lifestyle Intervention

Intervention Description

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 Outcome Measure Information:

Title

Body weight (Percent Change)

Description

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

Time Frame

Percent (%) Change from Baseline to Month 24

Secondary Outcome Measure Information:

Title

Body weight (kg)

Description

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

Time Frame

Change in kg from Baseline to Month 24

Title

Systolic Blood Pressure

Description

Resting systolic blood pressure is measured and is obtained from the electronic medical record.

Time Frame