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Clinical Trials/NCT01569490
NCT01569490
Completed
Not Applicable

Striving to Quit: First Breath Tobacco Cessation Research

University of Wisconsin, Madison1 site in 1 country3,100 target enrollmentSeptember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Smoking Cessation
Sponsor
University of Wisconsin, Madison
Enrollment
3100
Locations
1
Primary Endpoint
Abstinence from smoking
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
December 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Engagement in treatment(Measured 12 months after birth at follow-up assessment)
  • Cost-effectiveness(Measured 12 months after birth)

Study Sites (1)

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