Striving to Quit: First Breath

Smoking Cessation Clinical Trial

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Official title:

Striving to Quit: First Breath Tobacco Cessation Research

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01569490
• Other study ID #: 2012-0136
• Status: Completed
• Phase: N/A
• First received: March 30, 2012
• Last updated: February 28, 2017
• Start date: September 2012
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3100
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Dependence
• Smoking
• Smoking Cessation
• Tobacco Use Disorder

Intervention

Behavioral:
• Incentives for abstinence and treatment engagement
Treatment Incentives - incentives for biochemical verification visits, treatment engagement, and abstinence
• Attendance incentive
Attendance Incentives - incentives for only attending the biochemical verification visits

Locations

Country	Name	City	State
United States	Wisconsin Women's Health Foundation	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 6 months after births at follow-up assessment
Secondary	Engagement in treatment	The primary analyses will compare number of calls and visits completed.	Measured 12 months after birth at follow-up assessment
Secondary	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 12 months after birth