Clinical trial NCT05766761: Reducing Alcohol Exposed Pregnancies
Official title: Designing a Hybrid Intervention Strategy to Reduce Alcohol Exposed Pregnancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Drinking
Keywords: alcohol drinking in pregnancy
alcohol-exposed pregnancies
alcohol-related adverse birth outcomes
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center, Houston
name: Health Resources in Action, Inc.
name: Purdue University
First posted: 2023-03-13
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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. 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.

Detailed description: Prenatal alcohol exposure (PAE) increases the risk for Fetal Alcohol Spectrum Disorders (FASD). To address this health threat, researchers at New York University (NYU), the University of Texas Health Science Center-Houston, Purdue University, Health Resources in Action and the Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD) will develop, implement, and evaluate an alcohol intervention for women in prenatal care. This study is a randomized controlled trial (N=600) to assess the efficacy of an alcohol intervention, relative to usual prenatal care only, in reducing (1) women's alcohol use and 2) poor infant birth outcomes. We will recruit women at their first prenatal care visit. Eligible women complete a baseline assessment by a research nurse consisting of an Audio Computer-Assisted Self Interview (ACASI) and collection of bloodspots for phosphatidylethanol (PEth) analysis to assess alcohol consumption biologically. Subsequently, 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. Prenatal usual care involves clinicians assessing alcohol use and counseling women on alcohol-related risks. 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. Both components are theory-driven, based on Motivational Enhancement Theory (MET), and use motivational strategies to promote alcohol reduction. The alcohol intervention is developed with guidance from multiple sources, including (1) the project's Women's Advisory Board; recruited from the proposed recruitment clinics who self-report alcohol use during pregnancy, and (2) project investigators and consultants with extensive experience and expertise in research and trial design, and developing and implementing Screening, brief intervention and referral to treatment (SBIRTs) for reducing alcohol use and other drugs among women, including pregnant women. The alcohol intervention is delivered on three occasions: (1) following the baseline and the 2nd- and 3rd-trimester assessments. Women randomized to receive usual prenatal care only complete assessments on the same schedule as women in the intervention condition. We will use generalized estimating equation models and an intent-to-treat analysis to evaluate the efficacy of the intervention condition relative to the usual prenatal care condition in (1) increasing the proportion of women detected with a laboratory-confirmed negative PEth test during pregnancy and (2) reducing the proportion of adverse birth outcomes among infants. The proposed research is scientifically and clinically significant. If demonstrated effective, the intervention may represent a scalable alcohol reduction strategy suitable for prenatal clinical care in other maternity hospitals and clinical sites to reduce prenatal alcohol exposure and adverse birth outcomes. If successful, this would be the first prevention intervention for CIFASD.

Eligibility 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

Primary outcomes:
measure: Negative PEth among women
timeFrame: Through study completion, on average 6 months post-enrollment
Secondary outcomes:
measure: Pre-term births
timeFrame: At birth
measure: Low birth weight
timeFrame: At birth
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center, Houston
state: Texas
Study officials:
affiliation: New York University
name: Ralph DiClemente, PhD
role: PRINCIPAL_INVESTIGATOR
References: