Skip to main content
OpenTrials
Completed

NCT Number: NCT00153478

Project CHOICES Efficacy Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Risk for an Alcohol-Exposed Pregnancy Alcohol Drinking Alcohol-Induced Disorders Alcohol-Related Disorders Behavior Binge Drinking Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Drinking Behavior Female Urogenital Diseases and Pregnancy Complications Fetal Alcohol Spectrum Disorders Fetal Diseases Hazardous Alcohol Use Mental Disorders Pregnancy Complications Risk for Unintended Pregnancy Substance-Related Disorders Urogenital Diseases

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Broward County Health District Primary Care Centers, Fort Lauderdale, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

Brief Motivational Counseling

Behavioral

Primary outcomes

  1. Reduced risks for AEP;reduced risk drinking and reduced episodes of unprotected intercourse.

Secondary outcomes

  1. Mediators and moderators of reduced risk in the IPC and IO groups.

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Registry information

Official study title

Project CHOICES Efficacy Study for Preventing Alcohol-Exposed Pregnancies

Important dates

Study start
2002
Study completion
2004
First posted
Sep 12, 2005
Registry last updated
Sep 12, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.