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Completed

NCT Number: NCT01032772

ChoicesPlus: Reducing Alcohol- and Tobacco-Exposed Pregnancy

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.

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Key information

Conditions

Alcohol Use Alcohol Drinking Behavior Contraception Drinking Behavior Smoking

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Settegast Health Center, Houston, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Choices Plus

Behavioral

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

Information

Behavioral

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

Other names: Treatment As Usual

Primary outcomes

  1. Risk of alcohol-exposed pregnancy

    Time frame: 9 months

    Timeline Followback

Secondary outcomes

  1. 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-18

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Acronym: ChoicesPlus

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 15, 2009
Registry last updated
Nov 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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