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ChoicesPlus: Reducing Alcohol- and Tobacco-Exposed Pregnancy

ChoicesPlus: Preconception Approach to Reducing Alcohol- and Tobacco-Exposed Pregnancy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01032772
Acronym
ChoicesPlus
Enrollment
261
Registered
2009-12-15
Start date
2010-01-31
Completion date
2013-09-30
Last updated
2015-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use, Contraception, Smoking

Keywords

alcohol-exposed pregnancy, tobacco-exposed pregnancy, alcohol, contraception, smoking, pregnancy

Brief summary

Choices Plus, a randomized controlled study, will determine the efficacy of the Project CHOICES intervention plus a referral to an evidence-based smoking cessation program in reducing the risk of alcohol- and tobacco-exposed pregnancies.

Detailed description

This randomized controlled study will examine the effect of the ChoicesPlus intervention compared to Treatment as Usual (TAU) in: reducing alcohol use below established risk levels; increasing consistent use of effective contraception; increasing engagement in smoking cessation treatment and increasing smoking cessation. In addition, our examination of the incremental costs of the ChoicesPlus intervention (e.g., staff time, materials, administrative services, total medical charges pre- and post-intervention) will provide a basis for future cost/benefit analyses that will inform policymakers and healthcare organizations of the potential benefits of implementing ChoicesPlus. Results from this study will inform and advance future efforts in the service of promoting healthy prenatal behavior and reducing the prevalence of alcohol and tobacco-exposed pregnancies.

Interventions

BEHAVIORALChoices Plus

Participants in this condition will receive two brief, motivational-interviewing-based counseling sessions.

BEHAVIORALInformation

Participants are provided with informational materials about healthy lifestyle and local resources.

Sponsors

Centers for Disease Control and Prevention
CollaboratorFED
University of Texas at Austin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes

Inclusion criteria

* Have no condition causing infertility * Are not pregnant or planning to become pregnant in the next 9 months * Have had vaginal intercourse during the previous 3 months with a fertile man without using effective contraception * Are drinking at risk levels; and 5) are available for the follow-up period.

Exclusion criteria

* Infertile * Pregnant * Insufficient locator information * Language other than English or Spanish

Design outcomes

Primary

MeasureTime frameDescription
Risk of alcohol-exposed pregnancy9 monthsTimeline Followback

Secondary

MeasureTime frame
Marin Acculturation Scale, AUDIT, Time-Line Follow Back, University of Rhode Island Change Assessment Scale, Decisional Balance, Process of Change, Temptation, Confidence, Smoking Staging Algorithm, and Brief Symptom Inventory-189 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026