Promoting Successful Weight Loss in Primary Care in Louisiana Using Information Technology (PROPEL-IT)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05523375 |
Recruitment Status :
Active, not recruiting
First Posted : August 31, 2022
Last Update Posted : February 20, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity Diabetes Mellitus, Type 2 PreDiabetes | Behavioral: Intensive Lifestyle Intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 352 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Promoting Successful Weight Loss in Primary Care in Louisiana Using Information Technology |
Actual Study Start Date : | August 29, 2022 |
Estimated Primary Completion Date : | March 31, 2026 |
Estimated Study Completion Date : | March 31, 2026 |
Arm | Intervention/treatment |
---|---|
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.
|
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. |
No Intervention: Usual Care
Patients in the usual care arm will receive their normal, usual care from their primary care team.
|
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05523375
United States, Louisiana | |
Pennington Biomedical Research Center | |
Baton Rouge, Louisiana, United States, 70808 |
Principal Investigator: | Peter T Katzmarzyk, PhD | Pennington Biomedical Research Center |
Responsible Party: | Peter T. Katzmarzyk, Associate Executive Director for Population and Public Health, Pennington Biomedical Research Center |
ClinicalTrials.gov Identifier: | NCT05523375 |
Other Study ID Numbers: |
PBRC 2021-072 P50MD017338 ( U.S. NIH Grant/Contract ) |
First Posted: | August 31, 2022 Key Record Dates |
Last Update Posted: | February 20, 2024 |
Last Verified: | February 2024 |
Individual Participant Data (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 Statistical Analysis Plan (SAP) 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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Diabetes Mellitus, Type 2 Weight Loss Body Weight Changes Body Weight |
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |