PregnancyToPICNCT03442530
Tobacco Use in Pregnancy Intervention for Cessation
A study testing ToPIC and Tobacco Treatment As Usual (TTAU) in people with Pregnancy, run by Kristin Ashford at 1 site in United States.
Trial summary
The proposed project will test the effectiveness of the novel delivery of an established tobacco cessation treatment among pregnant women in Kentucky. Tobacco use during pregnancy is one of the most modifiable risk factors associated with poor birth and maternal outcomes and yet smoking prevalence among pregnant women… 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
- Pregnancy
- What is being tested?
- ToPIC and Tobacco Treatment As Usual (TTAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2018to 15 Feb 2019
- 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
- pregnant
- tobacco user
- able to read and write English
- Medicaid eligible
Who cannot join
- male
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky College of Nursing
Lexington, Kentucky, 40536
About this study
The proposed project will test the effectiveness of the novel delivery of an established tobacco cessation treatment among pregnant women in Kentucky. Tobacco use during pregnancy is one of the most modifiable risk factors associated with poor birth and maternal outcomes and yet smoking prevalence among pregnant women in Kentucky is among the highest in the county and estimated to be twice that of the national average, with no meaningful declines observed in twenty years.
Read the detailed description
The purpose of this pilot project is to test effectiveness of a tobacco-treatment cessation intervention (American College of Obstetricians and Gynecologists (ACOG) 5 A's) through use of a non-physician healthcare champion from within the clinic's existing infrastructure. This Tobacco use in Pregnancy Intervention for Cessation (ToPIC) will involve training the identified healthcare provider to become a Certified Tobacco Treatment Specialist (CTTS) and to administer the 5 A's to pregnant Medicaid patients receiving prenatal care through two high-volume Kentucky obstetrics clinics. This trial will provide evidence to evaluate this approach to delivering an established intervention in clinical practice.
The Investigators propose to test the effectiveness of the clinical intervention by using a two-armed cluster randomized controlled design. Eligible participants will be randomized to the intervention (ToPIC) or standard of care for smoking cessation in pregnancy. This pilot project will gather quantitative and qualitative data for a mixed-method, multi-stakeholder process evaluation of intervention training and delivery. Furthermore, the Investigators' use of Medicaid claims data to examine healthcare utilization outside of maternal and infant well-care visits will enhance understanding of the strengths and limitations of these data for future evaluations. This study has the potential to significantly impact the most vulnerable in Kentucky, where rates of tobacco use among pregnant women are among the highest in the nation.
- Conditions
- Pregnancy
- Being tested
- ToPIC, Tobacco Treatment As Usual (TTAU)
- Keywords
- pregnancy, smoking cessation, tobacco, preterm birth, ToPIC
- Medical subject headings
- Smoking Cessation, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToPICBehavioural
Expanded tobacco cessation counseling for pregnant women.
Tobacco Treatment As Usual (TTAU)Behavioural
Standard of care tobacco cessation counseling for pregnant women
| Study group | Role | What they receive |
|---|---|---|
| Tobacco Treatment As Usual (TTAU) | Active comparator | Eligible women assigned to the control group will be informed of the risks of tobacco use and benefits of quitting using the ACOG 5A's approach by their healthcare provider.5 This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The study coordinator will invite participants to complete the tobacco use questionnaires (TUQ),urine cotinine validation, and Expired Air Carbon Monoxide (EACO) analysis to assess ongoing tobacco use at the designated time points. Receives: Behavioral: Tobacco Treatment As Usual (TTAU) |
| ToPIC | Experimental | Eligible women assigned to the intervention will receive TTAU plus ToPIC administered by the CTTS. At least once monthly, at routinely scheduled prenatal visits or through telephone, the CTTS will provide cessation counseling. The CTTS will invite participants to complete TUQs,urine cotinine validation and EACO analysis to assess ongoing tobacco use at the designated time points. Receives: Behavioral: ToPIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation
Change in urine cotinine level
Measured: Baseline to third trimester
Secondary outcomes (5)
Number of cigarettes per day
Self-reported change in number of cigarettes smoked per day
Measured: Baseline to third trimester
Smoking cessation after delivery
Self-report smoking cessation
Measured: Prior to delivery hospitalization discharge, estimated 3 days
Infant birth weight
Infant weight measured in grams
Measured: At time of delivery
Gestational age
Weeks of gestation at delivery
Measured: At time of delivery
Health care utilization outside of well-visits
Maternal and infant visits for non-routine healthcare
Measured: Birth to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start22 Jan 2018
- Primary completion15 Feb 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristin Ashford
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky
- Responsible party
- Sponsor-investigator, Kristin Ashford, University of Kentucky
- Investigators
- Kristin Ashford, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442530
- Sponsor's protocol ID
- 17-0658-P3K
- Acronym
- ToPIC
- Status last verified
- Mar 2020
- First submitted
- 30 Jan 2018
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Use in Pregnancy Intervention for Cessation
- ClinicalTrials.gov ID
- NCT03442530
- Acronym / sponsor ID
- ToPIC / 17-0658-P3K
- Conditions
- Pregnancy
- Keywords
- pregnancy, smoking cessation, tobacco, preterm birth, ToPIC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Kristin AshfordUniversity, hospital or other
- Collaborators
- University of Kentucky
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 22 Feb 2018 (actual)
- 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.
The proposed project will test the effectiveness of the novel delivery of an established tobacco cessation treatment among pregnant women in Kentucky. Tobacco use during pregnancy is one of the most modifiable risk factors associated with poor birth and maternal outcomes and yet smoking prevalence among pregnant women in Kentucky is among the highest in the county and estimated to be twice that of the national average, with no meaningful declines observed in twenty years.
Detailed description
The purpose of this pilot project is to test effectiveness of a tobacco-treatment cessation intervention (American College of Obstetricians and Gynecologists (ACOG) 5 A's) through use of a non-physician healthcare champion from within the clinic's existing infrastructure. This Tobacco use in Pregnancy Intervention for Cessation (ToPIC) will involve training the identified healthcare provider to become a Certified Tobacco Treatment Specialist (CTTS) and to administer the 5 A's to pregnant Medicaid patients receiving prenatal care through two high-volume Kentucky obstetrics clinics. This trial will provide evidence to evaluate this approach to delivering an established intervention in clinical practice.
The Investigators propose to test the effectiveness of the clinical intervention by using a two-armed cluster randomized controlled design. Eligible participants will be randomized to the intervention (ToPIC) or standard of care for smoking cessation in pregnancy. This pilot project will gather quantitative and qualitative data for a mixed-method, multi-stakeholder process evaluation of intervention training and delivery. Furthermore, the Investigators' use of Medicaid claims data to examine healthcare utilization outside of maternal and infant well-care visits will enhance understanding of the strengths and limitations of these data for future evaluations. This study has the potential to significantly impact the most vulnerable in Kentucky, where rates of tobacco use among pregnant women are among the highest in the nation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tobacco Treatment As Usual (TTAU) | Active comparator | Behavioral: Tobacco Treatment As Usual (TTAU)Eligible women assigned to the control group will be informed of the risks of tobacco use and benefits of quitting using the ACOG 5A's approach by their healthcare provider.5 This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The study coordinator will invite participants to complete the tobacco use questionnaires (TUQ),urine cotinine validation, and Expired Air Carbon Monoxide (EACO) analysis to assess ongoing tobacco use at the designated time points. |
| ToPIC | Experimental | Behavioral: ToPICEligible women assigned to the intervention will receive TTAU plus ToPIC administered by the CTTS. At least once monthly, at routinely scheduled prenatal visits or through telephone, the CTTS will provide cessation counseling. The CTTS will invite participants to complete TUQs,urine cotinine validation and EACO analysis to assess ongoing tobacco use at the designated time points. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- pregnant
- tobacco user
- able to read and write English
- Medicaid eligible
Key exclusion criteria (1 listed)
- male
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 |
|---|---|---|
| ToPICExpanded tobacco cessation counseling for pregnant women. | Behavioural | ToPIC |
| Tobacco Treatment As Usual (TTAU)Standard of care tobacco cessation counseling for pregnant women | Behavioural | Tobacco Treatment As Usual (TTAU) |
Primary outcome
Smoking cessation
Time frame: Baseline to third trimester
Change in urine cotinine level
5 secondary outcomes
Number of cigarettes per day
Time frame: Baseline to third trimester
Smoking cessation after delivery
Time frame: Prior to delivery hospitalization discharge, estimated 3 days
Infant birth weight
Time frame: At time of delivery
Gestational age
Time frame: At time of delivery
Health care utilization outside of well-visits
Time frame: Birth to 6 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 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Kristin Ashford principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ToPIC and Tobacco Treatment As Usual (TTAU) in people with Pregnancy, run by Kristin Ashford at 1 site 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 1 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 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Smoking cessation (time frame: Baseline to third trimester). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2020.