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Striving to Quit: First Breath

Striving to Quit: First Breath Tobacco Cessation Research

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01569490
Acronym
STQ FB
Enrollment
3100
Registered
2012-04-03
Start date
2012-09-30
Completion date
2016-12-31
Last updated
2017-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nicotine Dependence, Smoking, Smoking Cessation

Brief 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.

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.

Interventions

Treatment Incentives - incentives for biochemical verification visits, treatment engagement, and abstinence

Attendance Incentives - incentives for only attending the biochemical verification visits

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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 * 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Abstinence from smokingMeasured 6 months after births at follow-up assessmentThe data will be the biochemically confirmed reports of abstinence for the past 7 days (i.e., 7-day point-prevalence abstinence)

Secondary

MeasureTime frameDescription
Engagement in treatmentMeasured 12 months after birth at follow-up assessmentThe primary analyses will compare number of calls and visits completed.
Cost-effectivenessMeasured 12 months after birthThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026