Reducing Alcohol Exposed Pregnancies

NCT05766761 | Recruiting DMC

• 1 other identifier: 1U01AA030187-01
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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. 1.increase the proportion of women detected with a laboratory-confirmed negative phosphatidylethanol (PEth) test during pregnancy, and
2. 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

Keywords

alcohol drinking in pregnancy; alcohol-exposed pregnancies; alcohol-related adverse birth outcomes

Outcome Measures

Primary Outcomes (1)

• Negative PEth among women

  Proportion of women detected with a laboratory-confirmed negative PEth test during pregnancy

  Through study completion, on average 6 months post-enrollment

Secondary Outcomes (2)

• Pre-term births

  At birth

• Low birth weight

  At birth

Study Arms (2)

Intervention condition, the usual prenatal care plus the alcohol intervention

EXPERIMENTAL

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.

Behavioral: Intervention condition, the usual prenatal care plus the alcohol intervention

Comparison condition, usual prenatal care only

NO INTERVENTION

Prenatal usual care involves clinicians assessing alcohol use and counseling women on alcohol-related risks.

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.

Intervention condition, the usual prenatal care plus the alcohol intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Can get pregnant
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Under 18 years of age
• Not pregnant or gestational age over 28 weeks
• No recent alcohol use as assessed by self-report

Sponsors & Collaborators

• New York University: lead
• The University of Texas Health Science Center, Houston: collaborator
• Health Resources in Action, Inc.: collaborator
• Purdue University: collaborator

Study Sites (1)

The University of Texas Health Science Center, Houston

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

• Capasso A, Stotts AL, Xu MA, Manuel BD, Zelaya S, Casillas SJ, Villarreal YR, Dorow A, Brown JL, Xu S, Concheiro-Guisan M, Fonseca Pego AM, Wingood GM, Beegle SAP, DiClemente RJ; Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD). Safe start, a hybrid intervention to reduce alcohol exposed pregnancies: protocol for a randomized controlled trial. BMC Public Health. 2026 Jan 10;26(1):506. doi: 10.1186/s12889-025-26044-2.

  PMID: 41520132 DERIVED

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol; Methods

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Investigative Techniques

Study Officials

• Ralph DiClemente, PhD

  New York University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Lunstroth

CONTACT

1-888-472-9868; cphs@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible women are randomized to either (1) the intervention condition, the usual prenatal plus the alcohol intervention, or (2) the comparison condition, usual prenatal care only.

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 13, 2023
• Study Start: April 15, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will become available after the study completion for a period of 5 years
• Access Criteria: Will be available via the CIFASD data repository

Locations

US (1)