NCT01032772

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
261

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2009

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

November 25, 2015

Status Verified

November 1, 2015

Enrollment Period

3.7 years

First QC Date

December 12, 2009

Last Update Submit

November 23, 2015

Conditions

Alcohol UseSmokingContraception

Keywords

alcohol-exposed pregnancytobacco-exposed pregnancyalcoholcontraceptionsmokingpregnancy

Outcome Measures

Primary Outcomes (1)

  • Risk of alcohol-exposed pregnancy

    Timeline Followback

    9 months

Secondary Outcomes (1)

  • 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

Study Arms (2)

CHOICES Plus Intervention

EXPERIMENTAL

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

Information

ACTIVE COMPARATOR

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

Behavioral: Information

Interventions

Choices PlusBEHAVIORAL

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

CHOICES Plus Intervention
InformationBEHAVIORAL

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

Also known as: Treatment As Usual
Information

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Infertile
  • Pregnant
  • Insufficient locator information
  • Language other than English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Settegast Health Center

Houston, Texas, 77028, United States

Location

Strawberry Health Center

Pasadena, Texas, 77506, United States

Location

Related Publications (2)

  • 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.

    PMID: 39072280DERIVED

  • 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.

    PMID: 28427955DERIVED

MeSH Terms

Conditions

Alcohol DrinkingSmoking

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Officials

  • Mary M Velasquez, Ph.D.

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

  • Kirk von Sternberg, Ph.D.

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2009

First Posted

December 15, 2009

Study Start

January 1, 2010

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

November 25, 2015

Record last verified: 2015-11

Locations

US(2)