Project CHOICES Efficacy Study

This study has been completed.
Sponsor:
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00153478
First received: September 8, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Project CHOICES Efficacy Study for Preventing Alcohol-Exposed Pregnancies

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Reduced risks for AEP;reduced risk drinking and reduced episodes of unprotected intercourse.

Secondary Outcome Measures:
  • Mediators and moderators of reduced risk in the IPC and IO groups.

Estimated Enrollment: 1200
Study Start Date: July 2002
Estimated Study Completion Date: August 2004
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

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153478

Locations
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
Plane State Jail
Dayton, Texas, United States, 77030
Sally's House
Houston, 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
New Directions
Houston, Texas, United States, 77030
Harris County Jail
Houston, Texas, United States, 77030
United States, Virginia
Outpatient Gynecology Clinic-Virginia Commonwealth Univ
Richmond, Virginia, United States, 23298
Medicaid Helath Maintenance Organization
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00153478     History of Changes
Other Study ID Numbers: CDC-NCBDDD-3271
Study First Received: September 8, 2005
Last Updated: September 8, 2005
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
Alcohol-Exposed Pregnancy
Binge drinking
Frequent drinking
Unintended pregnancy
Fetal Alcohol Syndrome

ClinicalTrials.gov processed this record on October 22, 2014