Reducing Alcohol Exposed Pregnancies

Sponsor

New York University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05766761

Collaborator

The University of Texas Health Science Center, Houston (Other), Health Resources in Action, Inc. (Other), Purdue University (Other)

600

Enrollment

Location

Arms

39.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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:

increase the proportion of women detected with a laboratory-confirmed negative PEth test during pregnancy, and
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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Drinking	Behavioral: Intervention condition, the usual prenatal care plus the alcohol intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Designing a Hybrid Intervention Strategy to Reduce Alcohol Exposed Pregnancies

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Apr 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
No Intervention: Comparison condition, usual prenatal care only Prenatal usual care involves clinicians assessing alcohol use and counseling women on alcohol-related risks.

Arm

Intervention/Treatment

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.

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.

No Intervention: Comparison condition, usual prenatal care only

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

Outcome Measures

Primary Outcome Measures

Negative PEth among women [Through study completion, on average 6 months post-enrollment]
Proportion of women detected with a laboratory-confirmed negative PEth test during pregnancy

Secondary Outcome Measures

Pre-term births [At birth]
Proportion of infants whose gestational age is <37 weeks
Low birth weight [At birth]
Proportion of infants who weighed less than 2500 grams at birth

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years and above
Gestational age is 8 weeks or less
Recent alcohol use as assessed by a positive EtG or self-report of alcohol use in the previous 21 days

Exclusion Criteria:

Under 18 years of age
Not pregnant or gestational age over 8 weeks
No recent alcohol use

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center, Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

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

Investigators

Principal Investigator: Ralph DiClemente, PhD, New York University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

New York University

ClinicalTrials.gov Identifier:

NCT05766761

Other Study ID Numbers:

1U01AA030187-01

First Posted:

Mar 13, 2023

Last Update Posted:

Mar 13, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by New York University

alcohol drinking in pregnancy

alcohol-exposed pregnancies

alcohol-related adverse birth outcomes

Additional relevant MeSH terms:

Alcohol Drinking

Study Results

No Results Posted as of Mar 13, 2023