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

NCT04174521 | Completed Results

• 1 other identifier: 190557
• Study Type: observational
• Target: 20,670
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Childhood

Outcome Measures

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.

  first 5 years of child's life

Study Arms (1)

Mother-Child

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

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator
• University of Pennsylvania: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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.

Results Point of Contact

• Title: Bryan Shepherd
• Organization: Vanderbilt University Medical Center

bryan.shepherd@vumc.org

615-343-3496

Study Officials

• Bryan Shepherd, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Biostatistics

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 22, 2019
• Study Start: June 26, 2019
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: January 31, 2022
• Results First Posted: January 31, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)