Intensive Lifestyle Intervention for Obesity
Phase-Based Progress Estimates
Effectiveness
Safety
Pennington Biomedical Research Center, Baton Rouge, LA
Obesity+3 More
Intensive Lifestyle Intervention - BehavioralEligibility
18+
All Sexes
What conditions do you have?
Select
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
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
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: BehavioralUsual 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 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.
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Conditions
Cancer Related
Treatments