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Sponsored by: |
Centers for Disease Control and Prevention |
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Information provided by: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00153478 |
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.
Condition | Intervention | Phase |
---|---|---|
Risk for an Alcohol-Exposed Pregnancy Hazardous Alcohol Use Risk for Unintended Pregnancy |
Behavioral: Brief Motivational Counseling |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Project CHOICES Efficacy Study for Preventing Alcohol-Exposed Pregnancies |
Estimated Enrollment: | 1200 |
Study Start Date: | July 2002 |
Estimated Study Completion Date: | August 2004 |
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.
Ages Eligible for Study: | 18 Years to 44 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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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United States, Florida | |
Media Recruited Participants from Broward County | |
Ft. Lauderdale, Florida, United States, 33314 | |
Broward County Health District Primary Care Centers | |
Ft. Lauderdale, Florida, United States, 33314 | |
United States, Texas | |
Harris County Jail | |
Houston, Texas, United States, 77030 | |
Plane State Jail | |
Dayton, Texas, United States, 77030 | |
Houston Recovery Campus | |
Houston, Texas, United States, 77030 | |
Door to Recovery | |
Houston, Texas, United States, 77030 | |
Career and Recovery | |
Houston, Texas, United States, 77030 | |
Sally's House | |
Houston, Texas, United States, 77030 | |
New Directions | |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
Medicaid Helath Maintenance Organization | |
Richmond, Virginia, United States, 23298 | |
Outpatient Gynecology Clinic-Virginia Commonwealth Univ | |
Richmond, Virginia, United States, 23298 |
Principal Investigator: | Rosa L Floyd, DSN | Centers for Disease Control and Prevention |
Principal Investigator: | Mark B Sobell, PhD | Nova Southeastern University |
Principal Investigator: | Mary V. Velasquez, PhD | The University of Texas Health Science Center, Houston |
Principal Investigator: | Karen Ingersol, PhD | Virginia Commonwealth University |
Study ID Numbers: | CDC-NCBDDD-3271 |
Study First Received: | September 8, 2005 |
Last Updated: | September 8, 2005 |
ClinicalTrials.gov Identifier: | NCT00153478 |
Health Authority: | United States: Federal Government |
Alcohol-Exposed Pregnancy Binge drinking Frequent drinking Unintended pregnancy Fetal Alcohol Syndrome |
Fetal Alcohol Syndrome Fetal alcohol syndrome Alcohol Drinking Ethanol |