Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00153478
Status:
COMPLETED
Last Update Posted:
2005-09-12
First Post:
2005-09-08
Brief Title:
Project CHOICES Efficacy Study
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Project CHOICES Efficacy Study for Preventing Alcohol-Exposed Pregnancies
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 pregnanciesAEPin 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 OnlyIO 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 andor 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 informationconsequences 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None