SmokingNCT02952703
Disseminating and Implementing a Smoking Cessation Program for Pregnant and Postpartum Women
A study testing brief pre-delivery smoking cessation counseling, additional pre-delivery smoking cessation counseling and post- delivery smoking cessation counseling in people with Smoking and Tobacco Use Disorder, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study tests whether a smoking cessation intervention for pregnant women that extends postpartum (Striving to Quit (STQ)) can be implemented and disseminated outside of the research environment that established its effectiveness (40% maintained biochemically verified 6-month abstinence). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Smoking, Tobacco Use Disorder
- What is being tested?
- brief pre-delivery smoking cessation counseling, additional pre-delivery smoking cessation counseling and post- delivery smoking cessation counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to May 2018
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant;
- enrolled in First Breath;
- Resides in Wisconsin counties of Calumet, Fond Du Lac, Kewaunee, Menominee, Oconto, Shawno, Sheyboygan, Winnebago, Door, Brown, Outagamie, Manitowac, or Waupaca;
- English speaking;
- willingness to quit or reduce smoking in next 30 days or if already quit, desire to remain quit after delivery;
- daily smoking (at least 1 cigarette/day for at least 1 week in past 6 months;
- willing to provide updates in contact information
Who cannot join
- not pregnant;
- not smoking in past 6 months;
- involved in another smoking research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, 53711
About this study
Official title: Disseminating and Implementing a Smoking Cessation Program Fro Pregnant and Postpartum Women
This study tests whether a smoking cessation intervention for pregnant women that extends postpartum (Striving to Quit (STQ)) can be implemented and disseminated outside of the research environment that established its effectiveness (40% maintained biochemically verified 6-month abstinence). The research aim is:
Is Striving to Quit more effective in achieving postpartum smoking cessation than "First Breath," the current standard of care for pregnant women in Wisconsin who smoke?
250 women will be randomized into one of two study groups. Pregnant women in Group A (n=125) will receive the existing First Breath prenatal intervention. Those in Group B (Striving to Quit (STQ), n=125) will receive all Group A interventions, plus 1 additional prenatal home visit, 3 postpartum in-home smoking cessation counseling visits, 3 postpartum phone calls, and up to an additional $100 in gift cards. The primary outcome will be biochemically confirmed smoking cessation at 6-months postpartum.
- Conditions
- Smoking, Tobacco Use Disorder
- Being tested
- brief pre-delivery smoking cessation counseling, additional pre-delivery smoking cessation counseling, post- delivery smoking cessation counseling, incentives
- Medical subject headings
- Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brief pre-delivery smoking cessation counselingBehavioural
additional pre-delivery smoking cessation counselingBehavioural
post- delivery smoking cessation counselingBehavioural
incentivesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| First Breath | Active comparator | brief pre-natal smoking cessation counseling Receives: Behavioral: brief pre-delivery smoking cessation counseling |
| Striving to Quit | Experimental | Additional pre-natal counseling (in-person and telephonic); post delivery counseling (in-person and telephonic) and incentives Receives: Behavioral: additional pre-delivery smoking cessation counseling; Behavioral: post- delivery smoking cessation counseling; Behavioral: incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically verified smoking abstinence
Biochemically verified smoking abstinence: Breath Carbon Monoxide (CO)<9ppm
Measured: 6 months post intervention
Secondary outcomes (1)
Motivation to quit/remain quit
Motivation to quit/remain quit measured on a 5 point Likert scale
Measured: 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952703
- Sponsor's protocol ID
- 2016-1046
- Status last verified
- Oct 2018
- First submitted
- 31 Oct 2016
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disseminating and Implementing a Smoking Cessation Program Fro Pregnant and Postpartum Women
- ClinicalTrials.gov ID
- NCT02952703
- Acronym / sponsor ID
- 2016-1046
- Conditions
- Smoking, Tobacco Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 2 Nov 2016 (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.
This study tests whether a smoking cessation intervention for pregnant women that extends postpartum (Striving to Quit (STQ)) can be implemented and disseminated outside of the research environment that established its effectiveness (40% maintained biochemically verified 6-month abstinence). The research aim is:
Is Striving to Quit more effective in achieving postpartum smoking cessation than "First Breath," the current standard of care for pregnant women in Wisconsin who smoke?
250 women will be randomized into one of two study groups. Pregnant women in Group A (n=125) will receive the existing First Breath prenatal intervention. Those in Group B (Striving to Quit (STQ), n=125) will receive all Group A interventions, plus 1 additional prenatal home visit, 3 postpartum in-home smoking cessation counseling visits, 3 postpartum phone calls, and up to an additional $100 in gift cards. The primary outcome will be biochemically confirmed smoking cessation at 6-months postpartum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Breath | Active comparator | Behavioral: brief pre-delivery smoking cessation counselingbrief pre-natal smoking cessation counseling |
| Striving to Quit | Experimental | Behavioral: additional pre-delivery smoking cessation counseling, Behavioral: post- delivery smoking cessation counseling, Behavioral: incentivesAdditional pre-natal counseling (in-person and telephonic); post delivery counseling (in-person and telephonic) and incentives |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pregnant;
- enrolled in First Breath;
- Resides in Wisconsin counties of Calumet, Fond Du Lac, Kewaunee, Menominee, Oconto, Shawno, Sheyboygan, Winnebago, Door, Brown, Outagamie, Manitowac, or Waupaca;
- English speaking;
- willingness to quit or reduce smoking in next 30 days or if already quit, desire to remain quit after delivery;
Key exclusion criteria (3 listed)
- not pregnant;
- not smoking in past 6 months;
- involved in another smoking research study.
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 |
|---|---|---|
| brief pre-delivery smoking cessation counseling | Behavioural | First Breath |
| additional pre-delivery smoking cessation counseling | Behavioural | Striving to Quit |
| post- delivery smoking cessation counseling | Behavioural | Striving to Quit |
| incentives | Behavioural | Striving to Quit |
Primary outcome
Biochemically verified smoking abstinence
Time frame: 6 months post intervention
Biochemically verified smoking abstinence: Breath Carbon Monoxide (CO)<9ppm
1 secondary outcome
Motivation to quit/remain quit
Time frame: 6 months post intervention
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 12 Oct 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brief pre-delivery smoking cessation counseling, additional pre-delivery smoking cessation counseling and post- delivery smoking cessation counseling in people with Smoking and Tobacco Use Disorder, run by University of Wisconsin, Madison 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 7 inclusion and 3 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 12 Oct 2018. 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?
Biochemically verified smoking abstinence (time frame: 6 months post intervention). 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 12 Oct 2018.