Striving to Quit: First Breath

Not Applicable

Completed

• Conditions: Smoking Cessation; Smoking; Nicotine Dependence
• Interventions: Behavioral: Incentives for abstinence and treatment engagement; Behavioral: Attendance incentive

• Registration Number: NCT01569490
• Lead Sponsor: University of Wisconsin, Madison

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.

Study Timeline

• Study First Submitted: 2012-03-30
• Study First Submitted QC: 2012-03-30
• Study First Posted: 2012-04-03
• Study Start: 2012-09
• Primary Completion: 2015-12
• Study Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment incentives	Incentives for abstinence and treatment engagement	Incentives for biochemical verification visits, treatment engagement, and abstinence
Attendance incentive	Attendance incentive	Incentives for only attending the biochemical verification visits

Primary Outcome Measures

Name	Time	Method
Abstinence from smoking	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)

Secondary Outcome Measures

Name	Time	Method
Engagement in treatment	Measured 12 months after birth at follow-up assessment	The primary analyses will compare number of calls and visits completed.
Cost-effectiveness	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.

Trial Locations

Locations (1)

Wisconsin Women's Health Foundation; 🇺🇸 Madison, Wisconsin, United States