ChoicesPlus: Reducing Alcohol- and Tobacco-Exposed Pregnancy

The University of Texas System (UT)

Status: Completed

Conditions: Alcohol Use; Contraception; Smoking

Treatments: Behavioral: Choices Plus; Behavioral: Information

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01032772

5U84DD000438

Details and patient eligibility

About

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.

Full 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.

Enrollment: 261 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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261 participants in 2 patient groups

CHOICES Plus Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Choices Plus

Information

Active Comparator group

Description:

Women in the information condition receive advice and educational material from the research assistant about women's health and related referrals.

Treatment:

Behavioral: Information