- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04174521
Association Between Mother and Child Weight Gain: Statistical Methods With Validation
January 27, 2022 updated by: Bryan Shepherd, Vanderbilt University Medical Center
Using retrospective data from the Vanderbilt University Medical Center electronic health record, the investigators will study the association between mother's weight / weight change before and during pregnancy and the development of childhood obesity up until 5 years of age.
Study Overview
Status
Completed
Conditions
Detailed Description
The investigators are extracting de-identified retrospective data from the Vanderbilt University Medical Center electronic health record for mother-child pairs.
From this data, the investigators will study the association between mother weight change during pregnancy and the risk of her child developing obesity during the first 5 years of life.
Included mothers must have at least one weight measurement and at least one height measurement; they must have at least one child with weight/length measurements at birth and one additional same day height/weight measurement at or before 5 years of age.
Study Type
Observational
Enrollment (Actual)
20670
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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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
1 second and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Mothers who have delivered at VUMC and their children who are seen by Vanderbilt-affiliated physicians.
Description
Inclusion Criteria:
- Mother-child pairs in the Vanderbilt University Medical Center (VUMC) electronic health record.
- The mothers must have at least one height measurement.
- The mothers must also have at least one weight measurement during pregnancy.
- The child must have birth length and weight measures and at least one same day height/weight measurement during their first 5 years of life.
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
Cohorts and Interventions
Group / Cohort |
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Mother-Child
Mothers who have delivered at VUMC and their children who are seen by Vanderbilt-affiliated physicians.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Obesity of the Child (in the Mother-child Pair) During the First 5 Years of the Child's Life
Time Frame: first 5 years of child's life
|
Obesity of the child is defined as having a BMI-by-age classification greater than the 95th percentile based on the US CDC percentiles.
|
first 5 years of child's life
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bryan Shepherd, PhD, Vanderbilt University Medical 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)
June 26, 2019
Primary Completion (Actual)
August 1, 2021
Study Completion (Actual)
August 1, 2021
Study Registration Dates
First Submitted
November 20, 2019
First Submitted That Met QC Criteria
November 20, 2019
First Posted (Actual)
November 22, 2019
Study Record Updates
Last Update Posted (Actual)
January 31, 2022
Last Update Submitted That Met QC Criteria
January 27, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 190557
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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