Alcohol Consumption Clinical Trial
Official title:
A Media Based Motivational Intervention to Reduce Alcohol Exposed Pregnancies (AEPs)
Verified date | September 2016 |
Source | Nova Southeastern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The study evaluated the effectiveness of a mail-based self-guided motivational intervention based on Project CHOICES to reduce alcohol-exposed pregnancies (AEP) with female students and non-students 18 to 44 years of age living in Florida. The investigators hypothesize that the motivational intervention will significantly reduce more women's risk of an AEP than will an informational intervention aimed at preventing fetal alcohol syndrome. Materials will be available in Spanish and English
Status | Completed |
Enrollment | 354 |
Est. completion date | March 2009 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 44 Years |
Eligibility |
Inclusion Criteria: - Women aged 18 to 44 years who are not pregnant, not trying to become pregnant, and able to bear children. - At risk for an alcohol exposed pregnancy 90 days prior to the interview defined as: 1. had heterosexual vaginal intercourse with ineffective contraception 2. not effectively using contraception 3. drinking either = 8 drinks per week on average or = 5 drinks in a single day or both 4. returned their informed consent and assessment materials within 60 days after it was mailed to them Exclusion Criteria: - No alcohol consumption or vaginal intercourse in the 90 days prior to the interview - Pregnant - Trying to become pregnant - Not able to bear children - Using contraception effectively |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Nova Southeastern University | Fort. Lauderdale | Florida |
Lead Sponsor | Collaborator |
---|---|
Nova Southeastern University | Centers for Disease Control and Prevention |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AEP reduced risk through reduced drinking and effective contraception, or both | Not at risk if a women reported no risky drinking (see definition in outcome 2) or contracepting effectively, or both | 6 months post intervention | No |
Primary | AEP reduced risk through reduced drinking only | Reduced risk drinking defined as = 7 standard drinks (SDs) per week and = 4 SDs on any day during the 6-month follow-up interval; 1 SD = 14 g absolute alcohol. | 6 months post intervention | No |
Primary | AEP reduced risk through effective contraception only | The effectiveness of birth control methods was evaluated using algorithms (e.g., If you missed a pill during this time period, did you take both pills the next day and did you use a back up method other than rhythm or withdrawal until you started your next packet of pills?) from Project CHOICES | 6 months post intervention | No |
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