Striving to Quit: First Breath
This trial is active, not recruiting.
|Conditions||smoking cessation, smoking, nicotine dependence|
|Treatments||incentives for abstinence and treatment engagement, attendance incentive|
|Sponsor||University of Wisconsin, Madison|
|Start date||September 2012|
|End date||December 2015|
|Trial size||3100 participants|
|Trial identifier||NCT01569490, 2012-0136|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Abstinence from smoking
time frame: Measured 6 months after births at follow-up assessment
Engagement in treatment
time frame: Measured 12 months after birth at follow-up assessment
time frame: Measured 12 months after birth
Female participants at least 18 years old.
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
|Official title||Striving to Quit: First Breath Tobacco Cessation Research|
|Principal investigator||Timothy B. Baker, PhD|
|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.|
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