CClinicalTrials.gg
CompletedNCT04174521Updated Jan 31, 2022Results posted

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

An observational study in Obesity, Childhood, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2022-01-31.

Sponsored by Vanderbilt University Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
20,670
Ages
0 Years and older
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Obesity, Childhood
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In context

Pediatric Obesity

1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.

This study's enrollment of 20,670 is above the median of 200 across 231 observational studies indexed under Pediatric Obesity.

Browse Pediatric Obesity studies →

Lead sponsor

Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.

Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
0 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Eligibility criteria

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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
20,670 participants (actual)
Patient registry
No

Groups and cohorts

  • Mother-Child

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

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What researchers measure

Primary outcomes

  1. Obesity of the Child (in the Mother-child Pair) During the First 5 Years of the 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.

    Time frame: first 5 years of child's life

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Results

Posted Jan 31, 2022
Limitations and caveats
This was a retrospective observational study, and subject to all of the usual challenges with that type of data (e.g., confounding and measurement error). The data provided here are extracted from the electronic health record and may be prone to errors. We performed an extensive chart review for a subset of 996 mother-child records and incorporated these validated data into analyses using statistical methods that account for measurement error.

Participant flow

Participant flow — Overall Study
MilestoneMother-Child
Started20670
Completed20670
Not completed0

Outcome measures

PrimaryObesity of the Child (in the Mother-child Pair) During the First 5 Years of the 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.

Time frame:
first 5 years of child's life
Reported as:
Count of participants · Participants
Obesity of the Child (in the Mother-child Pair) During the First 5 Years of the Child's Life
ParticipantsMother-Child
Obesity of the Child (in the Mother-child Pair) During the First 5 Years of the Child's Life1845

Adverse events

Collected over Retrospective observational study; not applicable. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Mother-Child———

Baseline characteristics

Mother-child pairs meeting inclusion criteria, mothers and children are reported individually.

Age, Continuous
Age, Continuous(years)Mother-Child
Maternal Age at delivery28 (23.5 to 32.3)
Child Age at delivery0 (0 to 0)
Sex: Female, Male
Sex: Female, Male(Participants)Mother-Child
Maternal sex — Female10335
Maternal sex — Male0
Child sex — Female4887
Child sex — Male5448
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Mother-Child
Hispanic or Latino3082
Not Hispanic or Latino17168
Unknown or Not Reported420
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Mother-Child
American Indian or Alaska Native154
Asian1420
Native Hawaiian or Other Pacific Islander0
Black or African American4778
White12778
More than one race82
Unknown or Not Reported1458
Region of Enrollment
Region of Enrollment(participants)Mother-Child
United States20670
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Study locations

1 site
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 4, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04174521
Lead sponsor
Vanderbilt University Medical Center
Collaborators
Patient-Centered Outcomes Research Institute, University of Pennsylvania
Responsible party
Bryan Shepherd (Professor of Biostatistics, Vanderbilt University Medical Center) — Principal investigator
First posted
Nov 22, 2019
Start date
Jun 26, 2019
Primary completion
Aug 1, 2021
Completion
Aug 1, 2021
Results posted
Jan 31, 2022
Last update
Jan 31, 2022

Study contacts

Bryan Shepherd, PhD
principal investigator · Vanderbilt University Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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