- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06849206
Pennington Generation Cohort
March 13, 2025 updated by: Peter T. Katzmarzyk, Pennington Biomedical Research Center
The Pennington Generation Cohort is an observational study comprised of Louisiana families.
Families will be assessed at baseline for a variety of traits and behaviors, and then followed up over time to try to understand the role of lifestyle and the environment on the risk of developing obesity and other health outcomes.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Pennington Biomedical's Greaux Healthy initiative partners with communities to grow healthier generations by expanding the access and reach of Pennington Biomedical's evidence-based practices for the prevention and treatment of childhood obesity.
As part of Greaux Healthy, the Pennington Generation Cohort will help evaluate the impact of the program.
A sample of up to 1,500 children and adolescents and their families will be recruited from throughout Louisiana.
An initial physical exam will establish a baseline for each family with respect to lifestyle behaviors, genetics, and body size/composition.
This longitudinal cohort will also assess the association between participation in several childhood obesity prevention and treatment programs and subsequent obesity and related health outcomes.
Members of the longitudinal cohort will be followed in the future through clinical visits, questionnaires, and through optional linkages to electronic medical records and administrative databases such as the National Death Index, Social Security Death Master File, and health registry data.
Study Type
Observational
Enrollment (Estimated)
3000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Peter T Katzmarzyk, PhD
- Phone Number: 225-763-2536
- Email: Peter.katzmarzyk@pbrc.edu
Study Contact Backup
- Name: Kara Denstel, PhD
- Phone Number: 763-2614
- Email: kara.denstel@pbrc.edu
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Recruiting
- Pennington Biomedical Research Center
-
Contact:
- Peter T Katzmarzyk, PhD
- Phone Number: 225-763-2536
- Email: Peter.katzmarzyk@pbrc.edu
-
Contact:
- Peter T Katzmarzyk, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Adults of child-bearing age who are planning to become pregnant, expectant parents, as well as children, adolescents, and young adults and their nuclear family members will be recruited.
Description
Inclusion Criteria:
- Children, adolescents, and young adults (birth through age 24 years) and their nuclear family members* and adults age 25+ who are expectant parents or are trying to conceive
- Self-reported resident of Louisiana
- Ability to understand instructions and complete all study procedures
- Able to provide informed consent (adults aged over 18 years)
- Able to provide assent (children 9 to 17 years)
- Able to communicate (oral and written) in English
Exclusion Criteria:
- Discretion of the Medical Monitor or Principal Investigator
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Obesity
Time Frame: From enrollment up to 20 years of follow-up.
|
The development of obesity, defined using BMI z-scores during childhood, and BMI during adulthood.
|
From enrollment up to 20 years of follow-up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight change
Time Frame: From enrollment up to 20 years of follow-up.
|
Change in body weight.
|
From enrollment up to 20 years of follow-up.
|
|
Mortality
Time Frame: From enrollment up to 20 years of follow-up..
|
Data from the Pennington Generation Prospective Cohort will be prospectively linked to the National Death Index for the ascertainment of mortality.
|
From enrollment up to 20 years of follow-up..
|
|
Cancer incidence
Time Frame: From enrollment up to 20 years of follow-up..
|
Data from the Pennington Generation Prospective Cohort will be prospectively linked to the Louisiana Tumor Registry for the ascertainment of incident cancer.
|
From enrollment up to 20 years of follow-up..
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Peter T Katzmarzyk, PhD, Pennington Biomedical Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 24, 2025
Primary Completion (Estimated)
February 24, 2045
Study Completion (Estimated)
February 24, 2045
Study Registration Dates
First Submitted
February 19, 2025
First Submitted That Met QC Criteria
February 24, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 13, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-036
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
A de-identified individual-level dataset will be made available to researchers making a reasonable request to the principal investigator.
IPD Sharing Time Frame
Data will be made available 1 year after publication of the primary outcomes manuscript.
IPD Sharing Access Criteria
Upon reasonable request to the principal investigator and in alignment with the goals of the IRB-approved protocol.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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