Project CHOICES Efficacy Study
| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | September 8, 2005 | ||||||||||||||||
| Last Updated Date | September 8, 2005 | ||||||||||||||||
| Start Date ICMJE | July 2002 | ||||||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Reduced risks for AEP;reduced risk drinking and reduced episodes of unprotected intercourse. | ||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | No Changes Posted | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
Mediators and moderators of reduced risk in the IPC and IO groups. | ||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Project CHOICES Efficacy Study | ||||||||||||||||
| Official Title ICMJE | Project CHOICES Efficacy Study for Preventing Alcohol-Exposed Pregnancies | ||||||||||||||||
| Brief Summary | Project CHOICES Efficacy Study is a randomized controlled trial (RCT) designed to evaluate the clinical efficacy of a brief motivational intervention aimed at reducing alcohol-exposed pregnancies(AEP)in high-risk preconceptional women. The study is a multi-site collaborative study between the CDC and three universities. The hypothesis of the study is that a greater proportion of women will reduce thier risk of having an alcohol-exposed pregnancy after participating in the Information Plus Counseling (IPC) intervention than do those in the Information Only(IO) control group. |
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| Detailed Description | Women at high risk for an AEP are define as sexually active, fertile women who are drinking more than 7 drinks per week and/or 5 or more drinks on any one day, and are noy using effective measures to prevent pregnancy. Participants will be recruited from community-based setting previously shown to have increased proportions of women at risk for AEP. Women in the intervention group (IPC) will receive 4 counselling sessions that include personal feedback on AEP risk behaviors drawn from baseline information,consequences of alcohol use in pregnancy, assessing readiness to change risk behaviors, pros and cons of risk drinking and unprotected intercourse, goal setting to reduce risk behaviors, and a consultation visit with a family planning provider to discuss appropriate choices for pregnancy prevention based on clinical assessment. Clients are counseled that there are two routes to reducing AEP risk, alcohol reduction or pregnancy prevention, with the ideal being both. Women in the control group (IO) will receive an informational brochure that addresses healthy lifestyle behaviors, including alcohol use, and a list of referral sources for health care treatment and alcohol abuse treatment. Both groups will be assessed at baseline using a full battery of measures that include alcohol and contraceptive use with follow-up measures at 3, 6, and 9 months after baseline. |
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| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Phase | Phase 2 | ||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Brief Motivational Counseling | ||||||||||||||||
| Study Arm (s) | Not Provided | ||||||||||||||||
| 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 | Completed | ||||||||||||||||
| Enrollment ICMJE | 1200 | ||||||||||||||||
| Completion Date | August 2004 | ||||||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Women who: are not pregnant, are between the ages of 18 and 44 years, consume more than seven drinks per week and/or at least one binge episode (five or more drinks in one day) in the last 90 days (for the Texas jail & recovery center sites, this will be the 90 days before entering these facilities), are able to provide and do provide informed consent, are members of the special setting's population, and are available for follow-up through 9 months after recruitment. - Exclusion Criteria: Women who: do not meet the inclusion criteria, cannot commit to provide information about how to be contacted for follow-up, or are unable to understand spoken English. - |
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| Gender | Female | ||||||||||||||||
| Ages | 18 Years to 44 Years | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | United States | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT00153478 | ||||||||||||||||
| Other Study ID Numbers ICMJE | CDC-NCBDDD-3271 | ||||||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||||||
| Responsible Party | Not Provided | ||||||||||||||||
| Study Sponsor ICMJE | Centers for Disease Control and Prevention | ||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Centers for Disease Control and Prevention | ||||||||||||||||
| Verification Date | September 2005 | ||||||||||||||||
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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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