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

Primary Purpose

Alcohol Use, Smoking, Contraception

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Choices Plus
Information
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Use focused on measuring alcohol-exposed pregnancy, tobacco-exposed pregnancy, alcohol, contraception, smoking, pregnancy

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Settegast Health Center
  • Strawberry Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CHOICES Plus Intervention

Information

Arm 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.

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

Outcomes

Primary Outcome Measures

Risk of alcohol-exposed pregnancy
Timeline Followback

Secondary Outcome Measures

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

Full Information

First Posted
December 12, 2009
Last Updated
November 23, 2015
Sponsor
University of Texas at Austin
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01032772
Brief Title
ChoicesPlus: Reducing Alcohol- and Tobacco-Exposed Pregnancy
Acronym
ChoicesPlus
Official Title
ChoicesPlus: Preconception Approach to Reducing Alcohol- and Tobacco-Exposed Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use, Smoking, Contraception
Keywords
alcohol-exposed pregnancy, tobacco-exposed pregnancy, alcohol, contraception, smoking, pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHOICES Plus Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Information
Arm Type
Active Comparator
Arm Description
Women in the information condition receive advice and educational material from the research assistant about women's health and related referrals.
Intervention Type
Behavioral
Intervention Name(s)
Choices Plus
Intervention Description
Participants in this condition will receive two brief, motivational-interviewing-based counseling sessions.
Intervention Type
Behavioral
Intervention Name(s)
Information
Other Intervention Name(s)
Treatment As Usual
Intervention Description
Participants are provided with informational materials about healthy lifestyle and local resources.
Primary Outcome Measure Information:
Title
Risk of alcohol-exposed pregnancy
Description
Timeline Followback
Time Frame
9 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary M Velasquez, Ph.D.
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kirk von Sternberg, Ph.D.
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Settegast Health Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77028
Country
United States
Facility Name
Strawberry Health Center
City
Pasadena
State/Province
Texas
ZIP/Postal Code
77506
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28427955
Citation
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.
Results Reference
derived

Learn more about this trial

ChoicesPlus: Reducing Alcohol- and Tobacco-Exposed Pregnancy

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