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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)
Must not have
Disease/condition that is life threatening or can interfere with or be aggravated by exercise or weight loss
Currently participating in a structured weight loss program
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to month 24
Awards & highlights

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My condition can worsen with exercise or weight loss.
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I am currently in a weight loss program.
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My body weight is 400 lbs or more.
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I have lost more than 10 lbs in the last six months or am on weight loss medication.

Timeline

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

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

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
306 Previous Clinical Trials
181,682 Total Patients Enrolled
64 Trials studying Obesity
117,210 Patients Enrolled for Obesity
National Institute on Minority Health and Health Disparities (NIMHD)NIH
395 Previous Clinical Trials
1,342,528 Total Patients Enrolled
40 Trials studying Obesity
254,402 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
~164 spots leftby Mar 2026
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