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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

No Placebo-Only Group

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.

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.

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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body weight (Percent Change)

Secondary study objectives

Body weight (kg)

Diastolic Blood Pressure

Dietary Intake

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 7Eligibility criteria met