Fetal Programming of Obesity

Completed

• Conditions: Pregnancy; Healthy

• Registration Number: NCT01131117
• Lead Sponsor: Arkansas Children's Hospital Research Institute

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2010-04-02
• Study First Submitted: 2010-05-25
• Study First Submitted QC: 2010-05-25
• Study First Posted: 2010-05-26
• Primary Completion: 2018-08
• Study Completion: 2024-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 320

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Child body composition	24 months	lean and fat mass of the child

Secondary Outcome Measures

Name	Time	Method
Placenta gene expression	9 months	via gene microarray and real time PCR
Child development	24 months	Monitored from 2wks up to 24 months
Child metabolism	24 months	monitor with a metabolic cart
Child dietary intake	24 months	Food records for each visit will be obtained
Placenta protein content	9 months	via gene microarray and real time PCR

Trial Locations

Locations (1)

Arkansas Children's Nutrition Center; 🇺🇸 Little Rock, Arkansas, United States