NCT00153478

Project CHOICES Efficacy Study

Project CHOICES Efficacy Study for Preventing Alcohol-Exposed Pregnancies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,200 (planned)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Risk for an Alcohol-Exposed Pregnancy
• Hazardous Alcohol Use
• Risk for Unintended Pregnancy

Interventions

Type	Name	Description
BEHAVIORAL	Brief Motivational Counseling

Timeline

• Start date: 2002-07-01
• Completion: 2004-08-01
• First posted: 2005-09-12
• Last updated: 2005-09-12

Locations

11 sites across 1 country: United States