Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
66 participants
INTERVENTIONAL
2018-01-22
2019-02-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Computer-Assisted Intervention for Smoking During Pregnancy
NCT01028131
Smoking Cessation for Low-Income Pregnant Women
NCT02211430
Helping Moms Who Smoke
NCT03104452
Preventing Postpartum Return to Smoking
NCT00917943
Testing Pharmacological Therapies for Pregnant Smokers
NCT00224419
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Tobacco Treatment As Usual (TTAU)
Standard of care tobacco cessation counseling for pregnant women
ToPIC
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.
ToPIC
Expanded tobacco cessation counseling for pregnant women.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ToPIC
Expanded tobacco cessation counseling for pregnant women.
Tobacco Treatment As Usual (TTAU)
Standard of care tobacco cessation counseling for pregnant women
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* tobacco user
* able to read and write English
* Medicaid eligible
Exclusion Criteria
18 Years
44 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Kentucky
OTHER
Kristin Ashford
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kristin Ashford
Associate Dean of Undergraduate Faculty Affairs, University of Kentucky College of Nursing
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kristin Ashford
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Kentucky College of Nursing
Lexington, Kentucky, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
17-0658-P3K
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.