Smoking CessationNCT03104452
Helping Moms Who Smoke
An observational study of Smoking Cessation, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to learn how women's smoking changes during their pregnancy and as a new mom, and to assess the help they receive from their health care providers. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 31 Jul 2021
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from obstetric and family practice clinics identified by the researchers.
Who may be able to join
- Smoked within six months prior to becoming pregnant or current smoking
- Smoked at least 100 cigarettes
- Pregnant
- English speaking
- Access to a cell phone
- Willing to receive and send text messages.
Who cannot join
- Quit for longer than 6 months before becoming pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Enhancing the Delivery of Tobacco Treatment During Pregnancy and Postpartum Though Systems-Change
The purpose of this study is to learn how women's smoking changes during their pregnancy and as a new mom, and to assess the help they receive from their health care providers.
Read the detailed description
Approximately 90% of women who smoked before pregnancy will be smokers within one year of delivery . This occurs even though half who smoke quit during the course of pregnancy. This is an observational, cohort study of pregnant women who smoked in the six months before becoming pregnant. Women will be followed from the first trimester to one year after the birth of their babies. The results of this study will help us to describe women's' views on the quality of tobacco counseling they receive from their doctors; understand patterns of smoking and quitting throughout pregnancy and after childbirth; and provide information needed to develop an intervention to help women quit.
- Conditions
- Smoking Cessation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Smokers | Participants are pregnant women who smoked in the six months prior to their pregnancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking status
The investigators will assess 7-day point prevalence smoking status over multiple time-points over the study period
Measured: 1 year post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start1 Mar 2019
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taneisha Scheuermann, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104452
- Sponsor's protocol ID
- K01DA040745
- Status last verified
- Aug 2021
- First submitted
- 3 Apr 2017
- Last updated
- 26 Aug 2021
- 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 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Delivery of Tobacco Treatment During Pregnancy and Postpartum Though Systems-Change
- ClinicalTrials.gov ID
- NCT03104452
- Acronym / sponsor ID
- K01DA040745
- Conditions
- Smoking Cessation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 7 Apr 2017 (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 purpose of this study is to learn how women's smoking changes during their pregnancy and as a new mom, and to assess the help they receive from their health care providers.
Detailed description
Approximately 90% of women who smoked before pregnancy will be smokers within one year of delivery . This occurs even though half who smoke quit during the course of pregnancy. This is an observational, cohort study of pregnant women who smoked in the six months before becoming pregnant. Women will be followed from the first trimester to one year after the birth of their babies. The results of this study will help us to describe women's' views on the quality of tobacco counseling they receive from their doctors; understand patterns of smoking and quitting throughout pregnancy and after childbirth; and provide information needed to develop an intervention to help women quit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Smokers | – | –Participants are pregnant women who smoked in the six months prior to their pregnancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from obstetric and family practice clinics identified by the researchers.
Key inclusion criteria (6 listed)
- Smoked within six months prior to becoming pregnant or current smoking
- Smoked at least 100 cigarettes
- Pregnant
- English speaking
- Access to a cell phone
Key exclusion criteria (1 listed)
- Quit for longer than 6 months before becoming pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Smoking status
Time frame: 1 year post-partum
The investigators will assess 7-day point prevalence smoking status over multiple time-points over the study period
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 26 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Smoking Cessation
Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
Active, not recruitingEarly Phase 1
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Smoking Cessation
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.
Taneisha Scheuermann, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation, run by University of Kansas Medical Center 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 6 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 26 Aug 2021. 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 status (time frame: 1 year post-partum). 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 26 Aug 2021.