Reducing Alcohol Exposed Pregnancies

Part of paid clinical trials in Houston, Texas.

Sponsor
New York University
Study ID
NCT05766761
Status
Recruiting
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Conditions

  • Alcohol Drinking

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intervention condition, the usual prenatal care plus the alcohol intervention — BEHAVIORAL
    The intervention is theory-driven, based on Motivational Enhancement Theory (MET), and uses motivational strategies to promote alcohol reduction.

Study Details

The goal of this clinical trial is to compare an active intervention versus a standard of care control in reducing alcohol use among pregnant women. The main questions it aims to answer are whether a motivational intervention can: 1. increase the proportion of women detected with a laboratory-confirmed negative phosphatidylethanol (PEth) test during pregnancy, and 2. reduce the proportion of adverse birth outcomes among infants. Participants will be offered (1) a self-paced computer-delivered alcohol reduction intervention to enhance knowledge, norms, and motivation for alcohol reduction and (2) a nurse-delivered component to reinforce the computer-delivered content and address women's questions. Both components are theory-driven, based on Motivational Enhancement Theory (MET), and use motivational strategies to promote alcohol reduction.

Key Dates

Start date
Apr 15, 2024
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention condition, the usual prenatal care plus the alcohol intervention
    The alcohol intervention consists of (1) a self-paced computer-delivered component to enhance knowledge, norms, and motivation for alcohol reduction and (2) a nurse-delivered component to reinforce the computer-delivered content and address women's questions.
  • No Intervention: Comparison condition, usual prenatal care only
    Prenatal usual care involves clinicians assessing alcohol use and counseling women on alcohol-related risks.

Primary Outcome Measure

Negative PEth among women [ Time Frame: Through study completion, on average 6 months post-enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center, HoustonHoustonTexas77030
Angela Stotts, PhD
[email protected]
713-500-7590

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By research site
The University of Texas Health Science Center, Houston· Houston, TX

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