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Project CHOICES Efficacy Study

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Brief Motivational Counseling
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Risk for an Alcohol-Exposed Pregnancy focused on measuring Alcohol-Exposed Pregnancy, Binge drinking, Frequent drinking, Unintended pregnancy, Fetal Alcohol Syndrome

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

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. -

Sites / 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

Outcomes

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.

Full Information

First Posted
September 8, 2005
Last Updated
September 8, 2005
Sponsor
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT00153478
Brief Title
Project CHOICES Efficacy Study
Official Title
Project CHOICES Efficacy Study for Preventing Alcohol-Exposed Pregnancies
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centers for Disease Control and Prevention

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Brief Motivational Counseling
Primary Outcome Measure Information:
Title
Reduced risks for AEP;reduced risk drinking and reduced episodes of unprotected intercourse.
Secondary Outcome Measure Information:
Title
Mediators and moderators of reduced risk in the IPC and IO groups.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
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. - 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa L Floyd, DSN
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark B Sobell, PhD
Organizational Affiliation
Nova Southeastern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mary V. Velasquez, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen Ingersol, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Broward County Health District Primary Care Centers
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33314
Country
United States
Facility Name
Media Recruited Participants from Broward County
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33314
Country
United States
Facility Name
Plane State Jail
City
Dayton
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Career and Recovery
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Door to Recovery
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Harris County Jail
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Recovery Campus
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
New Directions
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Sally's House
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Medicaid Helath Maintenance Organization
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Outpatient Gynecology Clinic-Virginia Commonwealth Univ
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

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Project CHOICES Efficacy Study

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