ChoicesPlus: Reducing Alcohol- and Tobacco-Exposed Pregnancy (ChoicesPlus)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01032772
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : November 25, 2015
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
University of Texas at Austin

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.

Condition or disease Intervention/treatment Phase
Alcohol Use Smoking Contraception Behavioral: Choices Plus Behavioral: Information Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 261 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: ChoicesPlus: Preconception Approach to Reducing Alcohol- and Tobacco-Exposed Pregnancy
Study Start Date : January 2010
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Arm Intervention/treatment
Experimental: CHOICES Plus Intervention
A two session intervention utilizing a motivational interviewing approach to encourage changes in alcohol use, contraceptive use, and smoking. The interventions will (a) provide norms-based-but personalized-feedback, (b) encourage attendance at a contraceptive counseling visit, (c) encourage participation in the smoking cessation program, (c) increase motivation to change each of the target behaviors, (d) decrease temptation to engage in risk behaviors, (e) increase confidence to avoid risk behaviors, and (f) develop a personalized, tailored change plan.
Behavioral: Choices Plus
Participants in this condition will receive two brief, motivational-interviewing-based counseling sessions.

Active Comparator: Information
Women in the information condition receive advice and educational material from the research assistant about women's health and related referrals.
Behavioral: Information
Participants are provided with informational materials about healthy lifestyle and local resources.
Other Name: Treatment As Usual

Primary Outcome Measures :
  1. Risk of alcohol-exposed pregnancy [ Time Frame: 9 months ]
    Timeline Followback

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01032772

United States, Texas
Settegast Health Center
Houston, Texas, United States, 77028
Strawberry Health Center
Pasadena, Texas, United States, 77506
Sponsors and Collaborators
University of Texas at Austin
Centers for Disease Control and Prevention
Principal Investigator: Mary M Velasquez, Ph.D. University of Texas at Austin
Principal Investigator: Kirk von Sternberg, Ph.D. University of Texas at Austin

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Texas at Austin Identifier: NCT01032772     History of Changes
Other Study ID Numbers: 5U84DD000438 ( U.S. NIH Grant/Contract )
First Posted: December 15, 2009    Key Record Dates
Last Update Posted: November 25, 2015
Last Verified: November 2015

Keywords provided by University of Texas at Austin:
alcohol-exposed pregnancy
tobacco-exposed pregnancy

Additional relevant MeSH terms:
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs