ChoicesPlus: Reducing Alcohol- and Tobacco-Exposed Pregnancy

NCT ID: NCT01032772

Last Updated: 2015-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

261 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-09-30

Brief Summary

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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

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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.

Conditions

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Alcohol Use Smoking Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Choices Plus

Intervention Type BEHAVIORAL

Participants in this condition will receive two brief, motivational-interviewing-based counseling sessions.

Information

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

Group Type ACTIVE_COMPARATOR

Information

Intervention Type BEHAVIORAL

Participants are provided with informational materials about healthy lifestyle and local resources.

Interventions

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Choices Plus

Participants in this condition will receive two brief, motivational-interviewing-based counseling sessions.

Intervention Type BEHAVIORAL

Information

Participants are provided with informational materials about healthy lifestyle and local resources.

Intervention Type BEHAVIORAL

Other Intervention Names

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Treatment As Usual

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary M Velasquez, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Kirk von Sternberg, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

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Settegast Health Center

Houston, Texas, United States

Site Status

Strawberry Health Center

Pasadena, Texas, United States

Site Status

Countries

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United States

References

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Northrup TF, Stotts AL, Fischer SM, von Sternberg KL, Velasquez MM. Increased risk for alcohol- and other substance-exposed pregnancies among women who smoke tobacco: A secondary analysis of a primary care-based intervention. Tob Induc Dis. 2024 Jul 26;22. doi: 10.18332/tid/191107. eCollection 2024.

Reference Type DERIVED
PMID: 39072280 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28427955 (View on PubMed)

Other Identifiers

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5U84DD000438

Identifier Type: NIH

Identifier Source: org_study_id

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