Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Fetal Programming of Obesity

This study is ongoing, but not recruiting participants.
USDA Beltsville Human Nutrition Research Center
University of Arkansas
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute Identifier:
First received: May 25, 2010
Last updated: December 17, 2014
Last verified: December 2014

The overall goal of this project is to understand how a mother's health at conception may influence her child's growth and development. One objective is to evaluate the effects of body composition of mothers on their children's risk of obesity at age two years. This will be accomplished by following pregnant mothers throughout their pregnancy while monitoring closely their gestational weight gain and by following their infants until age two years. The second objective is to carefully evaluate the metabolism of these mothers and children to identify pathways that could lead to a fetal programming of obesity.

Condition Intervention
Device: Observational study only

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Arkansas Children's Hospital Research Institute:

Primary Outcome Measures:
  • Child body composition [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Child growth and development [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Child metabolism [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Child dietary intake [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Placenta gene expression [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood, urine, placenta, cord blood and umbilical cord may be collected from study participants.

Estimated Enrollment: 320
Study Start Date: April 2010
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pregnant women Device: Observational study only
this study is observational only


Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy women


Inclusion Criteria:

  • healthy
  • 21 years of age or older
  • second pregnancy, singleton
  • conceived without fertility treatments
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01131117

United States, Arkansas
Arkansas Children's Nutrition Center
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
USDA Beltsville Human Nutrition Research Center
University of Arkansas
  More Information

No publications provided

Responsible Party: Arkansas Children's Hospital Research Institute Identifier: NCT01131117     History of Changes
Other Study ID Numbers: 110889
Study First Received: May 25, 2010
Last Updated: December 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Arkansas Children's Hospital Research Institute:
pregnancy processed this record on March 03, 2015