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Reducing Alcohol Exposed Pregnancies

NCT05766761 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-04-13

No results posted yet for this study

Summary

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.

Conditions

  • Alcohol Drinking

Interventions

BEHAVIORAL

Intervention condition, the usual prenatal care plus the alcohol intervention

The intervention is theory-driven, based on Motivational Enhancement Theory (MET), and uses motivational strategies to promote alcohol reduction.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • Health Resources in Action, Inc.

    collaborator OTHER

  • Purdue University

    collaborator OTHER

  • New York University

    lead OTHER

Principal Investigators

  • Ralph DiClemente, PhD · New York University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2026-09-30
Completion
2027-04-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05766761 on ClinicalTrials.gov