Project CHOICES Efficacy Study

Hazardous Alcohol Use Clinical Trial

Official title:

Project CHOICES Efficacy Study for Preventing Alcohol-Exposed Pregnancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00153478
• Other study ID #: CDC-NCBDDD-3271
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: September 8, 2005
• Start date: July 2002
• Est. completion date: August 2004

Study information

• Verified date: September 2005
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Brief Motivational Counseling

Locations

Country	Name	City	State
United States	Plane State Jail	Dayton	Texas
United States	Broward County Health District Primary Care Centers	Ft. Lauderdale	Florida
United States	Media Recruited Participants from Broward County	Ft. Lauderdale	Florida
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

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced risks for AEP;reduced risk drinking and reduced episodes of unprotected intercourse.
Secondary	Mediators and moderators of reduced risk in the IPC and IO groups.