Clinical trial NCT01032772: ChoicesPlus: Reducing Alcohol- and Tobacco-Exposed Pregnancy
Official title: ChoicesPlus: Preconception Approach to Reducing Alcohol- and Tobacco-Exposed Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use
Smoking
Contraception
Keywords: alcohol-exposed pregnancy
tobacco-exposed pregnancy
alcohol
contraception
smoking
pregnancy
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2009-12-15
Enrollment: 261
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Risk of alcohol-exposed pregnancy
timeFrame: 9 months
Secondary outcomes:
measure: 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
timeFrame: 9 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Settegast Health Center
state: Texas
city: Pasadena
country: United States
facility: Strawberry Health Center
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Mary M Velasquez, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas at Austin
name: Kirk von Sternberg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.