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e-Intervention for Alcohol Use in Pregnancy (e-Health Trial)

N/A

Recruiting

Led By Steven J Ondersma, PhD

Research Sponsored by Michigan State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-35 years

Be between 18 and 65 years old

Must not have

Unable to communicate in English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up entire period of gestation

Summary

This trial is testing a new alcohol intervention for pregnant women, to see if it reduces alcohol use and if booster sessions or text messages can help.

Who is the study for?

This trial is for pregnant women aged 18-35, less than 20 weeks along, living in Connecticut, Massachusetts, or Michigan. They must own a mobile device and have reported alcohol use that poses a risk to fetal health. Women not intending to carry the pregnancy to term or unable to communicate in English cannot participate.

What is being tested?

The study tests an app called MommyCheckup designed for pregnant women at risk of alcohol-related issues. It delivers brief interventions and checks if additional booster sessions or personalized text messages can further reduce alcohol consumption during pregnancy.

What are the potential side effects?

Since this trial involves non-medical interventions like apps and text messaging, there are no direct medical side effects. However, participants may experience stress or discomfort when discussing their alcohol use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot communicate in English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants abstinent from alcohol as measured by Timeline FollowBack Calendar Recall and Ethyl Glucuronide (EtG)

Secondary study objectives

Number of participants with a healthy birth outcome (full-term live birth of normal birthweight, with no days in NICU)

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: General information + SMSExperimental Treatment2 Interventions

SMS refers to tailored text messaging.

Group II: Baseline brief intervention + SMSExperimental Treatment2 Interventions

Brief technology-delivered intervention for alcohol use during pregnancy, plus tailored text messaging

Group III: Baseline brief intervention + 2 booster sessions + SMSExperimental Treatment3 Interventions

Brief technology-delivered intervention for alcohol use during pregnancy, plus two very brief (\<5 minutes) online boosters using the participants' own mobile device, plus tailored SMS.

Group IV: Baseline brief intervention + 2 booster sessionsExperimental Treatment2 Interventions

Brief technology-delivered intervention for alcohol use during pregnancy, plus two very brief (\<5 minutes) online boosters using the participants' own mobile device.

Group V: Baseline brief interventionExperimental Treatment1 Intervention

Brief technology-delivered intervention for alcohol use during pregnancy

Group VI: General informationPlacebo Group1 Intervention

Control

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SMS

2016

N/A

~61970