Striving to Quit: First Breath (STQ FB)
|ClinicalTrials.gov Identifier: NCT01569490|
Recruitment Status : Completed
First Posted : April 3, 2012
Last Update Posted : March 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation Smoking Nicotine Dependence||Behavioral: Incentives for abstinence and treatment engagement Behavioral: Attendance incentive||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Striving to Quit: First Breath Tobacco Cessation Research|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2016|
Experimental: Treatment incentives
Incentives for biochemical verification visits, treatment engagement, and abstinence
Behavioral: Incentives for abstinence and treatment engagement
Treatment Incentives - incentives for biochemical verification visits, treatment engagement, and abstinence
Active Comparator: Attendance incentive
Incentives for only attending the biochemical verification visits
Behavioral: Attendance incentive
Attendance Incentives - incentives for only attending the biochemical verification visits
- 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)
- Engagement in treatment [ Time Frame: Measured 12 months after birth at follow-up assessment ]The primary analyses will compare number of calls and visits completed.
- Cost-effectiveness [ Time Frame: Measured 12 months after birth ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569490
|United States, Wisconsin|
|Wisconsin Women's Health Foundation|
|Madison, Wisconsin, United States, 53713|
|Principal Investigator:||Timothy B. Baker, PhD||University of Wisconsin, Madison|