Reducing alcohol use among pregnant women
Designing a Hybrid Intervention Strategy to Reduce Alcohol Exposed Pregnancies
This study is testing whether a special program that helps pregnant women cut down on drinking alcohol works better than regular prenatal care alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | New York University Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05766761 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare an active intervention with standard prenatal care to reduce alcohol consumption among pregnant women. It involves a randomized controlled design with 600 participants, where women will receive either a motivational intervention combined with usual prenatal care or usual care alone. The intervention includes a self-paced computer program and a nurse-delivered component to enhance knowledge and motivation for alcohol reduction. The study will assess the effectiveness of this approach in achieving negative phosphatidylethanol (PEth) test results and improving infant birth outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 years and older, with a gestational age of 28 weeks or less, who have reported recent alcohol use.
Not a fit: Patients who are not pregnant, under 18 years of age, or have not consumed alcohol recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce alcohol-exposed pregnancies and improve health outcomes for infants.
How similar studies have performed: Other studies have shown success with motivational interventions for reducing alcohol use, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years and above * Gestational age is 28 weeks or less * Recent alcohol use as assessed by self-report of alcohol use in the previous 30 days Exclusion Criteria: * Under 18 years of age * Not pregnant or gestational age over 28 weeks * No recent alcohol use as assessed by self-report
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center, Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Ralph DiClemente, PhD — New York University
- Study coordinator: Rebecca Lunstroth
- Email: cphs@uth.tmc.edu
- Phone: 1-888-472-9868
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.