600 Participants Needed

Alcohol Reduction Program for Preventing Alcohol Exposure During Pregnancy

RL
Overseen ByRebecca Lunstroth
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: New York University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help pregnant women reduce alcohol use by testing a new intervention against standard prenatal care. It will explore whether a motivational program, known as the "Intervention condition," can result in more women having negative alcohol tests during pregnancy and healthier babies. Participants will use a computer-based program and receive nurse support to encourage reducing alcohol consumption. Women who are less than 28 weeks pregnant and have recently consumed alcohol may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to important research that could enhance prenatal care for future mothers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on reducing alcohol use during pregnancy.

What prior data suggests that this intervention is safe for pregnant women?

Research has shown that motivational programs can safely and effectively help pregnant women reduce alcohol use. These programs, offering both online and in-person support, have helped many women lower the risk of alcohol exposure to their babies. For example, one study found that 69% of participants reduced their risk of alcohol-exposed pregnancies.

These programs aim to increase understanding and motivation to drink less, using safe and non-invasive methods to encourage change. Importantly, no reports of serious side effects have emerged from participation, indicating that most women find them manageable.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it introduces a dual-component intervention to reduce alcohol exposure during pregnancy, which is different from the usual prenatal care. Unlike standard care that mainly involves clinician assessments and general counseling, this intervention combines a self-paced, computer-delivered component to boost knowledge and motivation with a personalized nurse-delivered component to address specific questions and reinforce learning. This innovative approach could lead to more effective alcohol reduction by tailoring support to individual needs and making education more engaging and accessible.

What evidence suggests that this motivational intervention is effective for reducing alcohol use during pregnancy?

Research has shown that motivational programs can help reduce alcohol use during pregnancy. In one study, 69% of women lowered their risk of having a baby exposed to alcohol after joining such a program. This trial includes an intervention condition where participants receive the usual prenatal care plus an alcohol intervention. The intervention consists of a self-paced computer-delivered component to enhance knowledge, norms, and motivation for alcohol reduction, along with a nurse-delivered component to reinforce the content and address questions. These programs typically teach about the dangers of drinking while pregnant and encourage women to stop. Self-paced learning tools, combined with nurse support, have guided women to make healthier choices. Short programs have also been somewhat successful in helping women stop drinking during pregnancy and in preventing early births. Overall, these methods aim to provide women with the information and support needed to reduce alcohol use.12678

Who Is on the Research Team?

RD

Ralph DiClemente, PhD

Principal Investigator

New York University

Are You a Good Fit for This Trial?

This trial is for pregnant women over 18, less than 8 weeks into their pregnancy, who have used alcohol in the last 21 days. It's not for those under 18, not pregnant or more than 8 weeks pregnant, and without recent alcohol use.

Inclusion Criteria

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

Exclusion Criteria

No recent alcohol use
Not pregnant or gestational age over 8 weeks

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline Assessment

Eligible women complete a baseline assessment including an Audio Computer-Assisted Self Interview (ACASI) and collection of bloodspots for phosphatidylethanol (PEth) analysis

1 week
1 visit (in-person)

Intervention

Participants receive a self-paced computer-delivered alcohol reduction intervention and a nurse-delivered component to reinforce the content

6 months
3 visits (in-person) during baseline, 2nd, and 3rd trimester assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of birth outcomes

6 months post-enrollment

What Are the Treatments Tested in This Trial?

Interventions

  • Intervention condition
Trial Overview The study tests if a computer-based program plus nurse support can help reduce drinking during pregnancy better than usual care. It uses motivational strategies to change behavior and aims to improve birth outcomes by decreasing positive PEth tests.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention condition, the usual prenatal care plus the alcohol interventionExperimental Treatment1 Intervention
Group II: Comparison condition, usual prenatal care onlyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials
249
Recruited
229,000+

The University of Texas Health Science Center, Houston

Collaborator

Trials
974
Recruited
361,000+

Health Resources in Action, Inc.

Collaborator

Trials
5
Recruited
2,000+

Purdue University

Collaborator

Trials
239
Recruited
72,200+

Published Research Related to This Trial

A significant portion of pregnant women in the U.S. engage in alcohol consumption, with 500,000 reporting drinking in the month before the study, which poses risks for fetal alcohol syndrome and neurodevelopmental disorders.
In a pilot study (Project CHOICES), 69% of women at high risk for alcohol-exposed pregnancies successfully reduced their risk, with those who had lower baseline drinking levels achieving the highest success rates primarily through effective contraception.
Motivational intervention to reduce alcohol-exposed pregnancies--Florida, Texas, and Virginia, 1997-2001.[2013]
In a study of 132 pregnant women, both an intervention group (58 women) receiving counseling and a control group (74 women) showed significant reductions in alcohol consumption during pregnancy, with 66% abstaining completely.
The reduction in alcohol use occurred independently of the counseling intervention, suggesting that pregnancy itself may motivate women to decrease or stop alcohol consumption, highlighting the need for structured counseling at early prenatal visits for those at higher risk.
Moderate alcohol consumption--need for intervention programs in pregnancy?Meberg, A., Halvorsen, B., Holter, B., et al.[2019]
A brief intervention consisting of 10- to 15-minute counseling sessions significantly increased the likelihood of pregnant women achieving alcohol abstinence, with those receiving the intervention being 5 times more likely to report abstinence compared to those who only received assessment.
Newborns of mothers who participated in the brief intervention had better outcomes, including higher birth weights and lengths, and a 3 times lower fetal mortality rate (0.9%) compared to those in the assessment-only group (2.9%).
Brief intervention for alcohol use by pregnant women.O'Connor, MJ., Whaley, SE.[2022]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/12807086/
Motivational intervention to reduce alcohol-exposed ...The findings indicate that although 69% of the women in the study reduced their risk for an alcohol-exposed pregnancy, women with the lowest ...
Motivational Intervention to Reduce Alcohol-Exposed ...The findings indicate that although 69% of the women in the study reduced their risk for an alcohol-exposed pregnancy, women with the lowest baseline drinking ...
NCT05766761 | Reducing Alcohol Exposed PregnanciesThis 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) ...
A cost‐effective intervention to reduce prenatal alcohol exposureThese findings highlight the effectiveness of low‐cost, self‐administered educational interventions in enhancing knowledge of risks and ...
Effectiveness of brief alcohol interventions for pregnant womenBIs are moderately effective in increasing abstinence during pregnancy and preventing preterm birth.
Motivational Interventions in Prenatal Clinics - PMCThis article presents information on adapting brief motivational approaches for alcohol interventions during prenatal health care and provides a specific model ...
Brief motivational enhancement intervention to prevent or ...The aim of this study is to assess the effect of brief motivational enhancement intervention postpartum alcohol use.
A Qualitative Evaluation of an Alcohol-Exposed Pregnancy ...Many interventions to prevent FASDs aim to reduce AUDs and risky drinking among pregnant women. However, a growing body of research indicates ...
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