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Behavioral Intervention

Intensive Lifestyle Intervention for Weight Loss (PROPEL-IT Trial)

N/A

Waitlist Available

Led By Peter T Katzmarzyk, PhD

Research Sponsored by Pennington Biomedical Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

40-70 years of age

Obesity (BMI 30.0-50.0 kg/m2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to month 24

Awards & highlights

PROPEL-IT Trial Summary

This trial is testing a new way to help people lose weight, by connecting them with a health coach who they can talk to through an online portal.

Who is the study for?

This trial is for Black/African American residents of Louisiana aged 40-70 with Type II diabetes or pre-diabetes, obesity (BMI 30.0-50.0 kg/m2), and internet access. Participants must be willing to change their diet/activity and not be pregnant, in a weight loss program, have life-threatening diseases, past bariatric surgery, or recent significant weight loss.Check my eligibility

What is being tested?

The study tests a remote intensive lifestyle intervention over 24 months for weight loss in primary care using technology. A health coach will guide patients through changes in diet and physical activity via an electronic medical record patient portal.See study design

What are the potential side effects?

While the trial itself may not directly cause side effects, changing one's diet and exercise routine can lead to fatigue, hunger pangs, muscle soreness initially; however individual experiences may vary.

PROPEL-IT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 70 years old.

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My BMI is between 30.0 and 50.0.

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I have been diagnosed with type II diabetes or pre-diabetes.

PROPEL-IT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to month 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to month 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Body weight (Percent Change)

Secondary outcome measures

Body weight (kg)

Diastolic Blood Pressure

Dietary Intake

+11 more

PROPEL-IT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intensive Lifestyle InterventionExperimental Treatment1 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.

Group II: Usual CareActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intensive Lifestyle Intervention

2016

N/A

~2850

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ochsner Health SystemOTHER

93 Previous Clinical Trials

184,309 Total Patients Enrolled

3 Trials studying Obesity

1,789 Patients Enrolled for Obesity

Pennington Biomedical Research CenterLead Sponsor

304 Previous Clinical Trials

181,084 Total Patients Enrolled

64 Trials studying Obesity

117,213 Patients Enrolled for Obesity

National Institute on Minority Health and Health Disparities (NIMHD)NIH

380 Previous Clinical Trials

1,215,302 Total Patients Enrolled

39 Trials studying Obesity

253,878 Patients Enrolled for Obesity

Media Library

Intensive Lifestyle Intervention (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05523375 — N/A

Obesity Research Study Groups: Usual Care, Intensive Lifestyle Intervention

Obesity Clinical Trial 2023: Intensive Lifestyle Intervention Highlights & Side Effects. Trial Name: NCT05523375 — N/A

Intensive Lifestyle Intervention (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05523375 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do applicants over the age of fifty fulfill the requirements for enrollment in this research endeavor?

"Patients aged 40 to 70 meet the requirements for this trial, whereas 249 studies are tailored towards those under 18 and 1370 study participants need to be over 65."

Answered by AI

How extensive is the participant pool of this research endeavor?

"Affirmative. Clinicaltrials.gov data indicates that this trial, initially posted on August 29th 2022, is currently recruiting individuals for participation. To complete the study, 352 participants must be sourced from one medical facility."

Answered by AI

Are there current opportunities for individuals to partake in this experiment?

"Affirmative, clinicaltrials.gov confirms that this medical trial is currently looking for participants with the initial posting occurring on August 29th of 2022 and a recent update being made September 8th of that same year. 352 individuals are sought out by the study at just one site."

Answered by AI

Who is the ideal candidate for inclusion in this research project?

"This trial seeks to recruit 352 patients aged 40-70 who self-identify as Black/African American and are currently suffering from obesity. Additionally, the selected individuals must have access to an internet connected device; be diagnosed with type II diabetes (or pre-diabetes); possess a MyOchsner portal account or create one; receive acknowledgement of their participation from their Ochsner primary care practitioner; have had their weight measured at an Ochsner clinic within 4 weeks prior to screening ; reside in Louisiana; and provide informed consent."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Peter T. Katzmarzyk 2022. "Promoting Successful Weight Loss in Primary Care in Louisiana Using Information Technology". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05523375.