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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04174521
Enrollment
20670
Registered
2019-11-22
Start date
2019-06-26
Completion date
2021-08-01
Last updated
2022-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Childhood

Brief 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.

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.

Interventions

None listed

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
University of Pennsylvania
CollaboratorOTHER
Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Obesity of the Child (in the Mother-child Pair) During the First 5 Years of the Child's Lifefirst 5 years of child's lifeObesity of the child is defined as having a BMI-by-age classification greater than the 95th percentile based on the US CDC percentiles.

Countries

United States

Participant flow

Participants by arm

ArmCount
Mother-Child
Mothers who have delivered at VUMC and their children who are seen by Vanderbilt-affiliated physicians.
20,670
Total20,670

Baseline characteristics

CharacteristicMother-Child
Age, Continuous
Child Age at delivery
0 years
Age, Continuous
Maternal Age at delivery
28 years
Ethnicity (NIH/OMB)
Hispanic or Latino
3082 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
17168 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
420 Participants
Race (NIH/OMB)
American Indian or Alaska Native
154 Participants
Race (NIH/OMB)
Asian
1420 Participants
Race (NIH/OMB)
Black or African American
4778 Participants
Race (NIH/OMB)
More than one race
82 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1458 Participants
Race (NIH/OMB)
White
12778 Participants
Region of Enrollment
United States
20670 participants
Sex: Female, Male
Child sex
Female
4887 Participants
Sex: Female, Male
Child sex
Male
5448 Participants
Sex: Female, Male
Maternal sex
Female
10335 Participants
Sex: Female, Male
Maternal sex
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mother-ChildObesity of the Child (in the Mother-child Pair) During the First 5 Years of the Child's Life1845 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026