Project CHOICES Efficacy Study
- Conditions
- Hazardous Alcohol UseRisk for Unintended PregnancyRisk for an Alcohol-Exposed Pregnancy
- Registration Number
- NCT00153478
- Lead Sponsor
- Centers for Disease Control and Prevention
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1200
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Reduced risks for AEP;reduced risk drinking and reduced episodes of unprotected intercourse.
- Secondary Outcome Measures
Name Time Method Mediators and moderators of reduced risk in the IPC and IO groups.
Trial Locations
- Locations (11)
Broward County Health District Primary Care Centers
🇺🇸Ft. Lauderdale, Florida, United States
Media Recruited Participants from Broward County
🇺🇸Ft. Lauderdale, Florida, United States
Plane State Jail
🇺🇸Dayton, Texas, United States
Career and Recovery
🇺🇸Houston, Texas, United States
Door to Recovery
🇺🇸Houston, Texas, United States
Harris County Jail
🇺🇸Houston, Texas, United States
Houston Recovery Campus
🇺🇸Houston, Texas, United States
New Directions
🇺🇸Houston, Texas, United States
Sally's House
🇺🇸Houston, Texas, United States
Medicaid Helath Maintenance Organization
🇺🇸Richmond, Virginia, United States
Outpatient Gynecology Clinic-Virginia Commonwealth Univ
🇺🇸Richmond, Virginia, United States