Project CHOICES Efficacy Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2004-08-31

Brief Summary

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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

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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.

Conditions

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

Keywords

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Alcohol-Exposed Pregnancy Binge drinking Frequent drinking Unintended pregnancy Fetal Alcohol Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Brief Motivational Counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Rosa L Floyd, DSN

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Mark B Sobell, PhD

Role: PRINCIPAL_INVESTIGATOR

Nova Southeastern University

Mary V. Velasquez, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Karen Ingersol, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

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United States

Other Identifiers

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CDC-NCBDDD-3271

Identifier Type: -

Identifier Source: org_study_id

Project CHOICES Efficacy Study

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

Brief Motivational Counseling

Eligibility Criteria

Inclusion Criteria

Sponsors

Centers for Disease Control and Prevention

Principal Investigators

Rosa L Floyd, DSN

Mark B Sobell, PhD

Mary V. Velasquez, PhD

Karen Ingersol, PhD

Locations

Broward County Health District Primary Care Centers

Media Recruited Participants from Broward County

Plane State Jail

Career and Recovery

Door to Recovery

Harris County Jail

Houston Recovery Campus

New Directions

Sally's House

Medicaid Helath Maintenance Organization

Outpatient Gynecology Clinic-Virginia Commonwealth Univ

Countries

Other Identifiers

CDC-NCBDDD-3271