Fetal Programming of Obesity

Healthy Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01131117
• Other study ID #: 110889
• Status: Active, not recruiting
• Start date: April 2, 2010
• Est. completion date: August 2024

Study information

• Verified date: December 2023
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: August 2024
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Pregnancy

Locations

Country	Name	City	State
United States	Arkansas Children's Nutrition Center	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child body composition	lean and fat mass of the child	24 months
Secondary	Child metabolism	monitor with a metabolic cart	24 months
Secondary	Child development	Monitored from 2wks up to 24 months	24 months
Secondary	Child dietary intake	Food records for each visit will be obtained	24 months
Secondary	Placenta gene expression	via gene microarray and real time PCR	9 months
Secondary	Placenta protein content	via gene microarray and real time PCR	9 months