ChoicesPlus: Reducing Alcohol- and Tobacco-Exposed Pregnancy

Not Applicable

Completed

• Conditions: Contraception; Alcohol Use; Smoking
• Interventions: Behavioral: Choices Plus; Behavioral: Information

• Registration Number: NCT01032772
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2009-12-12
• Study First Submitted QC: 2009-12-12
• Study First Posted: 2009-12-15
• Study Start: 2010-01
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-23
• Last Update Posted: 2015-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 261

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHOICES Plus Intervention	Choices Plus	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.
Information	Information	Women in the information condition receive advice and educational material from the research assistant about women's health and related referrals.

Primary Outcome Measures

Name	Time	Method
Risk of alcohol-exposed pregnancy	9 months	Timeline Followback

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Settegast Health Center; 🇺🇸 Houston, Texas, United States

Strawberry Health Center; 🇺🇸 Pasadena, Texas, United States