Intensive Lifestyle Intervention for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pennington Biomedical Research Center, Baton Rouge, LA
Obesity+3 More
Intensive Lifestyle Intervention - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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).

Eligible Conditions

  • Obesity
  • Diabetes Mellitus, Type 2
  • PreDiabetes

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 18 Secondary · Reporting Duration: Change from Baseline to Month 24

Month 24
Diastolic Blood Pressure
Dietary Intake
EuroQol-5 Dimension Questionnaire
HbA1c
Health Care Utilization
Health Care Utilization Questionnaire
Health-related Quality of Life
High-density Lipoprotein (HDL) Cholesterol
Impact of Weight on Quality of Life-Lite-Clinical Trials Questionnaire
Low-density Lipoprotein (LDL) cholesterol
Obesity-related Quality of Life
Perceived Stress
Perceived Stress Scale-4 Questionnaire
Physical Activity
Systolic Blood Pressure
Total Cholesterol
Triglycerides
Month 24
Body weight (kg)
Month 24
Body weight (Percent Change)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Usual Care
1 of 2
Intensive Lifestyle Intervention
1 of 2
Active Control
Experimental Treatment

352 Total Participants · 2 Treatment Groups

Primary Treatment: Intensive Lifestyle Intervention · No Placebo Group · N/A

Intensive Lifestyle Intervention
Behavioral
Experimental Group · 1 Intervention: Intensive Lifestyle Intervention · Intervention Types: Behavioral
Usual CareNoIntervention Group · 1 Intervention: Usual Care · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensive Lifestyle Intervention
2016
N/A
~2850

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to month 24

Trial Background

Peter T. Katzmarzyk, Associate Executive Director for Population and Public Health
Principal Investigator
Pennington Biomedical Research Center
Closest Location: Pennington Biomedical Research Center · Baton Rouge, LA
2007First Recorded Clinical Trial
57 TrialsResearching Obesity
215 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You self-identify as Black/African American.
You have an internet-connected device and are willing to use it for intervention delivery.
You are 30.0-50.0 kg/m2.
You are a Louisiana resident.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.