Alcohol UseChoicesPlusNCT01032772
ChoicesPlus: Reducing Alcohol- and Tobacco-Exposed Pregnancy
A study testing Choices Plus and Information in people with Alcohol Use and Smoking, run by University of Texas at Austin at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use, Smoking, Contraception
- What is being tested?
- Choices Plus and Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2010to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Infertile
- Pregnant
- Insufficient locator information
- Language other than English or Spanish
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Settegast Health Center
Houston, Texas, 77028
Strawberry Health Center
Pasadena, Texas, 77506
About this study
Official title: ChoicesPlus: Preconception Approach to Reducing Alcohol- and Tobacco-Exposed Pregnancy
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.
Read the 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.
- Conditions
- Alcohol Use, Smoking, Contraception
- Being tested
- Choices Plus, Information
- Keywords
- alcohol-exposed pregnancy, tobacco-exposed pregnancy, alcohol, contraception, smoking, pregnancy
- Medical subject headings
- Alcohol Drinking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choices PlusBehavioural
Participants in this condition will receive two brief, motivational-interviewing-based counseling sessions.
InformationBehavioural
Also called Treatment As Usual
Participants are provided with informational materials about healthy lifestyle and local resources.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of alcohol-exposed pregnancy
Timeline Followback
Measured: 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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol UseStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Mary M Velasquez, Ph.D., Principal investigator, University of Texas at AustinKirk von Sternberg, Ph.D., Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032772
- Sponsor's protocol ID
- 5U84DD000438
- Acronym
- ChoicesPlus
- Status last verified
- Nov 2015
- First submitted
- 12 Dec 2009
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 39072280Velasquez 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.
PubMed 28427955
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ChoicesPlus: Preconception Approach to Reducing Alcohol- and Tobacco-Exposed Pregnancy
- ClinicalTrials.gov ID
- NCT01032772
- Acronym / sponsor ID
- ChoicesPlus / 5U84DD000438
- Conditions
- Alcohol Use, Smoking, Contraception
- Keywords
- alcohol-exposed pregnancy, tobacco-exposed pregnancy, alcohol, contraception, smoking, pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Jan 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 15 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHOICES Plus Intervention | Experimental | Behavioral: Choices PlusA 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. |
| Information | Active comparator | Behavioral: InformationWomen in the information condition receive advice and educational material from the research assistant about women's health and related referrals. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Infertile
- Pregnant
- Insufficient locator information
- Language other than English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Choices PlusParticipants in this condition will receive two brief, motivational-interviewing-based counseling sessions. | Behavioural | CHOICES Plus Intervention |
| InformationAlso: Treatment As UsualParticipants are provided with informational materials about healthy lifestyle and local resources. | Behavioural | Information |
Primary outcome
Risk of alcohol-exposed pregnancy
Time frame: 9 months
Timeline Followback
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
- Derived from this study: PubMed 39072280Northrup 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.
- Derived from this study: PubMed 28427955Velasquez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary M Velasquez, Ph.D. principal investigator
University of Texas at Austin
Kirk von Sternberg, Ph.D. principal investigator
University of Texas at Austin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Choices Plus and Information in people with Alcohol Use and Smoking, run by University of Texas at Austin at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of alcohol-exposed pregnancy (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01032772, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2015.