Smoking CessationSTQ FBNCT01569490
Striving to Quit: First Breath
A study testing Incentives for abstinence and treatment engagement and Attendance incentive in people with Smoking Cessation and Smoking, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study is designed to test the hypotheses that incentives can increase both participation in smoking cessation treatment and resulting cessation rates, when they are offered to Medicaid BadgerCare Plus pregnant smokers. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Smoking Cessation, Smoking, Nicotine Dependence
- What is being tested?
- Incentives for abstinence and treatment engagement and Attendance incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 2016
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pregnant women
- enrollment in Wisconsin Medicaid (BadgerCare Plus or Medicaid SSI)
- resides in study area
- member of participating Medicaid HMOs
- not involved in any other stop smoking research studies
- 18 or older
Show all 11Show fewer
- English speaking
- smoked daily (at least one cigarette each day for at least one week) at some time within the last 6 months
- willingness to quit smoking, cut down, or stay quit
- willing to complete study visits and phone calls
- willing to provide updates in contact information
Who cannot join
- not enrolled in Wisconsin Medicaid (BadgerCare Plus or Medicaid SSI)
- not enrolled in study area
- not a member of participating Medicaid HMOs
- not pregnant or enrolled in First Breath
- less than 18 years of age
- non-English speaking
- does not smoke daily (at least one cigarette each day for at least one week) at least some time within the last 6 months
- not willing to complete study procedures and assessments or provide updated contact information
Trial locations and contacts
1 site in 1 country.
United States1 site
Wisconsin Women's Health Foundation
Madison, Wisconsin, 53713
About this study
Official title: Striving to Quit: First Breath Tobacco Cessation Research
This study is designed to test the hypotheses that incentives can increase both participation in smoking cessation treatment and resulting cessation rates, when they are offered to Medicaid BadgerCare Plus pregnant smokers.
Read the detailed description
Aim 1: To determine the extent to which contingent financial "treatment incentives" (i.e., incentives for biochemical verification visits, treatment engagement, and abstinence) versus "attendance incentives" (i.e., incentives for only attending the biochemical verification visits), increase rates of prenatal and postnatal smoking abstinence. Participants will be BadgerCare Plus members who are recruited into the First Breath program while pregnant.
Aim 2: To determine the extent to which treatment incentives, versus attendance incentives, increase rates of engagement in First Breath smoking cessation intervention when offered to pregnant and postpartum BadgerCare Plus members.
Aim 3: To determine the cost-effectiveness and reach of the First Breath intervention delivered to pregnant and postpartum smokers when it is paired with treatment incentives and when paired with only attendance incentives.
Aim 4: To determine if the First Breath intervention with treatment incentives, in comparison to that intervention with only attendance incentives, produces significantly greater benefits in pregnant and postpartum women with regards to nonsmoking health outcomes: i.e., reduced depression, increased levels of breast feeding, and greater perceived support.
Aim 5: To identify moderating and mediating effects of treatment incentives when offered in the context of the First Breath intervention delivered to pregnant and postpartum women.
- Conditions
- Smoking Cessation, Smoking, Nicotine Dependence
- Being tested
- Incentives for abstinence and treatment engagement, Attendance incentive
- Medical subject headings
- Smoking Cessation, Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentives for abstinence and treatment engagementBehavioural
Treatment Incentives - incentives for biochemical verification visits, treatment engagement, and abstinence
Attendance incentiveBehavioural
Attendance Incentives - incentives for only attending the biochemical verification visits
| Study group | Role | What they receive |
|---|---|---|
| Treatment incentives | Experimental | Incentives for biochemical verification visits, treatment engagement, and abstinence Receives: Behavioral: Incentives for abstinence and treatment engagement |
| Attendance incentive | Active comparator | Incentives for only attending the biochemical verification visits Receives: Behavioral: Attendance incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence from smoking
The data will be the biochemically confirmed reports of abstinence for the past 7 days (i.e., 7-day point-prevalence abstinence)
Measured: Measured 6 months after births at follow-up assessment
Secondary outcomes (2)
Engagement in treatment
The primary analyses will compare number of calls and visits completed.
Measured: Measured 12 months after birth at follow-up assessment
Cost-effectiveness
The primary analysis will contrast the incremental costs of the treatment vs. attendance conditions by computing the Incremental Cost-Effectiveness Ratio (ICER) with regard to attaining 6-month abstinence.
Measured: Measured 12 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy B. Baker, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569490
- Sponsor's protocol ID
- 2012-0136
- Acronym
- STQ FB
- Status last verified
- Feb 2017
- First submitted
- 30 Mar 2012
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Baker TB, Fraser DL, Kobinsky K, Adsit R, Smith SS, Khalil L, Alaniz KM, Sullivan TE, Johnson ML, Fiore MC. A randomized controlled trial of financial incentives to low income pregnant women to engage in smoking cessation treatment: Effects on post-birth abstinence. J Consult Clin Psychol. 2018 May;86(5):464-473. doi: 10.1037/ccp0000278. Epub 2018 Feb 1.
PubMed 29389142
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Striving to Quit: First Breath Tobacco Cessation Research
- ClinicalTrials.gov ID
- NCT01569490
- Acronym / sponsor ID
- STQ FB / 2012-0136
- Conditions
- Smoking Cessation, Smoking, Nicotine Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,100 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 3 Apr 2012 (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 is designed to test the hypotheses that incentives can increase both participation in smoking cessation treatment and resulting cessation rates, when they are offered to Medicaid BadgerCare Plus pregnant smokers.
Detailed description
Aim 1: To determine the extent to which contingent financial "treatment incentives" (i.e., incentives for biochemical verification visits, treatment engagement, and abstinence) versus "attendance incentives" (i.e., incentives for only attending the biochemical verification visits), increase rates of prenatal and postnatal smoking abstinence. Participants will be BadgerCare Plus members who are recruited into the First Breath program while pregnant.
Aim 2: To determine the extent to which treatment incentives, versus attendance incentives, increase rates of engagement in First Breath smoking cessation intervention when offered to pregnant and postpartum BadgerCare Plus members.
Aim 3: To determine the cost-effectiveness and reach of the First Breath intervention delivered to pregnant and postpartum smokers when it is paired with treatment incentives and when paired with only attendance incentives.
Aim 4: To determine if the First Breath intervention with treatment incentives, in comparison to that intervention with only attendance incentives, produces significantly greater benefits in pregnant and postpartum women with regards to nonsmoking health outcomes: i.e., reduced depression, increased levels of breast feeding, and greater perceived support.
Aim 5: To identify moderating and mediating effects of treatment incentives when offered in the context of the First Breath intervention delivered to pregnant and postpartum women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment incentives | Experimental | Behavioral: Incentives for abstinence and treatment engagementIncentives for biochemical verification visits, treatment engagement, and abstinence |
| Attendance incentive | Active comparator | Behavioral: Attendance incentiveIncentives for only attending the biochemical verification visits |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- pregnant women
- enrollment in Wisconsin Medicaid (BadgerCare Plus or Medicaid SSI)
- resides in study area
- member of participating Medicaid HMOs
- not involved in any other stop smoking research studies
Key exclusion criteria (8 listed)
- not enrolled in Wisconsin Medicaid (BadgerCare Plus or Medicaid SSI)
- not enrolled in study area
- not a member of participating Medicaid HMOs
- not pregnant or enrolled in First Breath
- less than 18 years of age
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 |
|---|---|---|
| Incentives for abstinence and treatment engagementTreatment Incentives - incentives for biochemical verification visits, treatment engagement, and abstinence | Behavioural | Treatment incentives |
| Attendance incentiveAttendance Incentives - incentives for only attending the biochemical verification visits | Behavioural | Attendance incentive |
Primary outcome
Abstinence from smoking
Time frame: Measured 6 months after births at follow-up assessment
The data will be the biochemically confirmed reports of abstinence for the past 7 days (i.e., 7-day point-prevalence abstinence)
2 secondary outcomes
Engagement in treatment
Time frame: Measured 12 months after birth at follow-up assessment
Cost-effectiveness
Time frame: Measured 12 months after birth
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 3 Mar 2017.
- Derived from this study: PubMed 29389142Baker TB, Fraser DL, Kobinsky K, Adsit R, Smith SS, Khalil L, Alaniz KM, Sullivan TE, Johnson ML, Fiore MC. A randomized controlled trial of financial incentives to low income pregnant women to engage in smoking cessation treatment: Effects on post-birth abstinence. J Consult Clin Psychol. 2018 May;86(5):464-473. doi: 10.1037/ccp0000278. Epub 2018 Feb 1.
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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.
Timothy B. Baker, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incentives for abstinence and treatment engagement and Attendance incentive in people with Smoking Cessation and Smoking, 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 11 inclusion and 8 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 3 Mar 2017. 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?
Abstinence from smoking (time frame: Measured 6 months after births at follow-up assessment). 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 NCT01569490, which also lists 1 linked publication.
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 3 Mar 2017.