ChoicesPlus: Reducing Alcohol- and Tobacco-Exposed Pregnancy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT01032772
First received: December 12, 2009
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Alcohol Use
Smoking
Contraception
Behavioral: Choices Plus
Behavioral: Information

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: ChoicesPlus: Preconception Approach to Reducing Alcohol- and Tobacco-Exposed Pregnancy

Resource links provided by NLM:


Further study details as provided by University of Texas at Austin:

Primary Outcome Measures:
  • Risk of alcohol-exposed pregnancy [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: January 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: Choices Plus
Participants in this condition will receive two brief, motivational-interviewing-based counseling sessions.
Active Comparator: Information
Women in the information condition receive advice and educational material from the research assistant about women's health and related referrals.
Behavioral: Information
Participants are provided with informational materials about healthy lifestyle and local resources.
Other Name: Treatment As Usual

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.

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032772

Locations
United States, Texas
Settegast Health Center
Houston, Texas, United States, 77028
Strawberry Health Center
Pasadena, Texas, United States, 77506
Sponsors and Collaborators
University of Texas at Austin
Investigators
Principal Investigator: Mary M Velasquez, Ph.D. University of Texas at Austin
Principal Investigator: Kirk von Sternberg, Ph.D. University of Texas at Austin
  More Information

No publications provided

Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT01032772     History of Changes
Other Study ID Numbers: 5U84DD000438
Study First Received: December 12, 2009
Last Updated: July 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas at Austin:
alcohol-exposed pregnancy
tobacco-exposed pregnancy
alcohol
contraception
smoking
pregnancy

Additional relevant MeSH terms:
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014