Clinical trial NCT00153478: Project CHOICES Efficacy Study
Official title: Project CHOICES Efficacy Study for Preventing Alcohol-Exposed Pregnancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Risk for an Alcohol-Exposed Pregnancy
Hazardous Alcohol Use
Risk for Unintended Pregnancy
Keywords: Alcohol-Exposed Pregnancy
Binge drinking
Frequent drinking
Unintended pregnancy
Fetal Alcohol Syndrome
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-09-12
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: 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.

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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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Primary outcomes:
measure: Reduced risks for AEP;reduced risk drinking and reduced episodes of unprotected intercourse.
Secondary outcomes:
measure: Mediators and moderators of reduced risk in the IPC and IO groups.
Other outcomes:
Locations:
city: Ft. Lauderdale
country: United States
facility: Broward County Health District Primary Care Centers
state: Florida
city: Ft. Lauderdale
country: United States
facility: Media Recruited Participants from Broward County
state: Florida
city: Dayton
country: United States
facility: Plane State Jail
state: Texas
city: Houston
country: United States
facility: Career and Recovery
state: Texas
city: Houston
country: United States
facility: Door to Recovery
state: Texas
city: Houston
country: United States
facility: Harris County Jail
state: Texas
city: Houston
country: United States
facility: Houston Recovery Campus
state: Texas
city: Houston
country: United States
facility: New Directions
state: Texas
city: Houston
country: United States
facility: Sally's House
state: Texas
city: Richmond
country: United States
facility: Medicaid Helath Maintenance Organization
state: Virginia
city: Richmond
country: United States
facility: Outpatient Gynecology Clinic-Virginia Commonwealth Univ
state: Virginia
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Rosa L Floyd, DSN
role: PRINCIPAL_INVESTIGATOR
affiliation: Nova Southeastern University
name: Mark B Sobell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Mary V. Velasquez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: Karen Ingersol, PhD
role: PRINCIPAL_INVESTIGATOR
References: