Fetal Programming of Obesity
This study is currently recruiting participants.
Verified January 2013 by Arkansas Children's Hospital Research Institute
Sponsor:
Arkansas Children's Hospital Research Institute
Collaborators:
USDA Beltsville Human Nutrition Research Center
University of Arkansas
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01131117
First received: May 25, 2010
Last updated: January 28, 2013
Last verified: January 2013
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Purpose
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 |
|---|---|
|
Healthy Pregnancy |
Device: Observational study only |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Resource links provided by NLM:
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: | May 2018 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Pregnant women |
Device: Observational study only
this study is observational only
|
Eligibility| 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
Criteria
Inclusion Criteria:
- healthy
- 21 years of age or older
- second pregnancy, singleton
- conceived without fertility treatments
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131117
Contacts
| Contact: Jill Harsch, BS | 501-364-3309 | acncstudies@uams.edu |
Locations
| United States, Arkansas | |
| Arkansas Children's Nutrition Center | Recruiting |
| Little Rock, Arkansas, United States, 72202 | |
| Contact: Rebecca Carter, MBA 501-364-3309 rcarter@uams.edu | |
| Principal Investigator: Aline Andres, PhD | |
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 |
| ClinicalTrials.gov Identifier: | NCT01131117 History of Changes |
| Other Study ID Numbers: | 110889 |
| Study First Received: | May 25, 2010 |
| Last Updated: | January 28, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Arkansas Children's Hospital Research Institute:
|
healthy women pregnancy |
ClinicalTrials.gov processed this record on May 16, 2013