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Completed

NCT Number: NCT01569490

Striving to Quit: First Breath

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wisconsin Women's Health Foundation

Madison, Wisconsin, 53713, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Incentives for abstinence and treatment engagement

Behavioral

Treatment Incentives - incentives for biochemical verification visits, treatment engagement, and abstinence

Attendance incentive

Behavioral

Attendance Incentives - incentives for only attending the biochemical verification visits

Primary outcomes

  1. 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

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Striving to Quit: First Breath Tobacco Cessation Research

Acronym: STQ FB

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Apr 3, 2012
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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