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NCT01971398 · ClinicalTrials.gov registry record · NA
Development of Education Materials for Prevention of FAS in Russia
A NA study, sponsored by University of Oklahoma.
- Completed
- Registry status
- NA
- Development phase
- 422
- Enrollment target
NCT01971398 is a NA study that has completed, run by University of Oklahoma. The registered enrollment target is 422 participants.
The verdict
NCT01971398, a NA study, has completed, sponsored by University of Oklahoma.
- COMPLETED
- Registry status
- NA
- Development phase
- 422 participants
- Enrollment target
Study Summary
This study is designed to increase knowledge and awareness to prevent Fetal Alcohol Syndrome in Russian children through development of printed FAS education materials targeting women of childbearing age in Russia. Alcohol abuse is a major public health problem in Russia. The rates of FAS and Alcohol Related Neurodevelopmental Disorders (ARND) in Russia are not precisely known. At this time, there are no programs to prevent FAS in Russia. The results of our previous study, focus groups with health professionals, pregnant women and their partners, non-pregnant women, and women with alcohol dependency, indicated limited knowledge about FAS, misconceptions about alcohol use during pregnancy, and a lack of materials and print resources related to this topic. Based on the initial findings, this proposal aims to develop and evaluate in a clinical trial informational brochures for women to increase knowledge and reduce drinking during pregnancy in Russia. The main hypotheses to be tested are: * 1\. Compared to the control group (CG) of women who receive a standard locally available flyer with health recommendations, women in the experimental groups who are exposed to printed information on FAS will show significantly more knowledge about FAS, significantly less acceptance of any alcohol use during pregnancy, and reduced drinking at one month follow-up assessment. * 2\. The group exposed to a brochure with negative images (IGN - Intervention group with a "negative brochure") regarding drinking during pregnancy will show significantly greater change in the predicted directions compared to the group exposed to positive images (IGP - Intervention group with a "positive" brochure) at the one month follow-up assessment.
Interventions
- BEHAVIORAL Positive FASD education brochure
- BEHAVIORAL Negative FASD education brochure
- BEHAVIORAL Active comparator (a general women's health brochure)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 422 participants |
| Start Date | 2007-04 |
| Est. Completion | 2007-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01971398
The ClinicalTrials.gov registry entry for NCT01971398 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 422 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Oklahoma, which has 358 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Positive FASD education brochure is the first listed.
NCT01971398 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01971398 about?
NCT01971398 is a clinical study titled "Development of Education Materials for Prevention of FAS in Russia". This study is designed to increase knowledge and awareness to prevent Fetal Alcohol Syndrome in Russian children through development of printed FAS education materials targeting women of childbearing age in Russia. Alcohol abuse is a major public health problem in Russia. The rates of FAS and Alcoho...
What is the current status of trial NCT01971398?
This trial is currently completed. It is a NA study. The enrollment target is 422 participants. The study started on 2007-04. Estimated completion is 2007-12.
What interventions are being tested in trial NCT01971398?
The interventions under investigation include: Positive FASD education brochure (BEHAVIORAL), Negative FASD education brochure (BEHAVIORAL), Active comparator (a general women's health brochure) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01971398?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
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