Fetal Programming of Obesity
| Tracking Information | |||||
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| First Received Date ICMJE | May 25, 2010 | ||||
| Last Updated Date | January 28, 2013 | ||||
| Start Date ICMJE | April 2010 | ||||
| Estimated Primary Completion Date | May 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Child body composition [ Time Frame: 3 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Child weight [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01131117 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Child body composition [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Fetal Programming of Obesity | ||||
| Official Title ICMJE | Not Provided | ||||
| 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. 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Blood, urine, placenta, cord blood and umbilical cord may be collected from study participants. |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Healthy women |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Observational study only
this study is observational only |
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| Study Group/Cohort (s) | Pregnant women
Intervention: Device: Observational study only |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 320 | ||||
| Estimated Completion Date | May 2018 | ||||
| Estimated Primary Completion Date | May 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Female | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01131117 | ||||
| Other Study ID Numbers ICMJE | 110889 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Arkansas Children's Hospital Research Institute | ||||
| Study Sponsor ICMJE | Arkansas Children's Hospital Research Institute | ||||
| Collaborators ICMJE |
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| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Arkansas Children's Hospital Research Institute | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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