Fetal Programming of Obesity

December 18, 2023 updated by: Arkansas Children's Hospital Research Institute
The overall goal of this project is to understand how a mother's health at conception may influence her child's growth and development.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Nutrition Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy women

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Pregnant women

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child body composition
Time Frame: 24 months
lean and fat mass of the child
24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arkansas Children's Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2010

Primary Completion (Actual)

August 1, 2018

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

May 25, 2010

First Submitted That Met QC Criteria

May 25, 2010

First Posted (Estimated)

May 26, 2010

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 110889

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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