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

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ClinicalTrials.gov Identifier: NCT01032772
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : November 25, 2015
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
University of Texas at Austin

December 12, 2009
December 15, 2009
November 25, 2015
January 2010
September 2013   (Final data collection date for primary outcome measure)
Risk of alcohol-exposed pregnancy [ Time Frame: 9 months ]
Timeline Followback
ChoicesPlus core assessment [ Time Frame: 9 months ]
Complete list of historical versions of study NCT01032772 on ClinicalTrials.gov Archive Site
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 ]
Marin Acculturation Scale, AUDIT, Time-Line Follow Back, URICA, Decisional Balance, Process of Change, Temptation, Confidence, Smoking Staging Algorithm, and BSI-18 [ Time Frame: 9 months ]
Not Provided
Not Provided
 
ChoicesPlus: Reducing Alcohol- and Tobacco-Exposed Pregnancy
ChoicesPlus: Preconception Approach to 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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
  • Alcohol Use
  • Smoking
  • Contraception
  • Behavioral: Choices Plus
    Participants in this condition will receive two brief, motivational-interviewing-based counseling sessions.
  • Behavioral: Information
    Participants are provided with informational materials about healthy lifestyle and local resources.
    Other Name: Treatment As Usual
  • 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.
    Intervention: Behavioral: Choices Plus
  • Active Comparator: Information
    Women in the information condition receive advice and educational material from the research assistant about women's health and related referrals.
    Intervention: Behavioral: Information
Velasquez MM, von Sternberg KL, Floyd RL, Parrish D, Kowalchuk A, Stephens NS, Ostermeyer B, Green C, Seale JP, Mullen PD. Preventing Alcohol and Tobacco Exposed Pregnancies: CHOICES Plus in Primary Care. Am J Prev Med. 2017 Jul;53(1):85-95. doi: 10.1016/j.amepre.2017.02.012. Epub 2017 Apr 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
261
600
September 2013
September 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 44 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01032772
5U84DD000438( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
University of Texas at Austin
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
University of Texas at Austin
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP