ChoicesPlus: Reducing Alcohol- and Tobacco-Exposed Pregnancy

Smoking Clinical Trial

— ChoicesPlus  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032772
• Other study ID #: 5U84DD000438
• Status: Completed
• Phase: N/A
• First received: December 12, 2009
• Last updated: November 23, 2015
• Start date: January 2010
• Est. completion date: September 2013

Study information

• Verified date: November 2015
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohol Use
• Contraception
• Smoking

Intervention

Behavioral:
• Choices Plus
Participants in this condition will receive two brief, motivational-interviewing-based counseling sessions.
• Information
Participants are provided with informational materials about healthy lifestyle and local resources.

Locations

Country	Name	City	State
United States	Settegast Health Center	Houston	Texas
United States	Strawberry Health Center	Pasadena	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of alcohol-exposed pregnancy	Timeline Followback	9 months	No
Secondary	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		9 months	No