Association Between Mother and Child Weight Gain: Statistical Methods With Validation

NCT ID: NCT04174521

Last Updated: 2022-01-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20670 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-26

Study Completion Date

2021-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity, Childhood

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Mother-Child

Mothers who have delivered at VUMC and their children who are seen by Vanderbilt-affiliated physicians.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Bryan Shepherd

Professor of Biostatistics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bryan Shepherd, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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190557

Identifier Type: -

Identifier Source: org_study_id

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