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Completed

NCT Number: NCT01131117

Fetal Programming of Obesity

The overall goal of this project is to understand how a mother's health at conception may influence her child's growth and development.

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Key information

Conditions

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

About this study

The purpose of this study is to determine how the mother's health prior to or at the beginning of pregnancy may influence her child's growth and development. We plan to: 1) longitudinally and simultaneously assess a true measure of body composition (lean and fat mass) of the offspring, assess body composition of both parents, and obtain dietary intake data of the mother and offspring; 2) determine endocrine and metabolic profiles of the mother at baseline (pre-conception), during pregnancy and at birth (such as insulin, glucose, leptin); 3) determine the energy expenditure and physical activity of the mother and the child; 4) determine gene expression of the placenta and umbilical cord via gene microarray and real time PCR; and 5) focused on appropriate-for-gestational age (AGA) infants (the majority of infants born from normal and overweight mothers).Accordingly, this study will provide much needed comprehensive information on the possible effect of fetal programming on the development of pediatric obesity.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy
  • 21 years of age or older
  • second pregnancy, singleton
  • conceived without fertility treatments

Exclusion criteria

  • Preexisting medical conditions
  • Sexually transmitted diseases
  • Medical complications during pregnancy
  • Medications during pregnancy known to influence fetal growth
  • Smoking, alcohol drinking
  • Excessive physical activity level which could affect the outcome of interest.

Treatment and study plan

Primary outcomes

  1. Child body composition

    Time frame: 24 months

    lean and fat mass of the child

Secondary outcomes

  1. Child metabolism

    Time frame: 24 months

    monitor with a metabolic cart

  2. Child development

    Time frame: 24 months

    Monitored from 2wks up to 24 months

  3. Child dietary intake

    Time frame: 24 months

    Food records for each visit will be obtained

  4. Placenta gene expression

    Time frame: 9 months

    via gene microarray and real time PCR

  5. Placenta protein content

    Time frame: 9 months

    via gene microarray and real time PCR

Sponsors and collaborators

Lead sponsor

Arkansas Children's Hospital Research Institute

Other

Registry information

Important dates

Study start
2010
Primary completion
2018
Study completion
2024
First posted
May 26, 2010
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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