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Striving to Quit: First Breath (STQ FB)

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ClinicalTrials.gov Identifier: NCT01569490
Recruitment Status : Completed
First Posted : April 3, 2012
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Smoking Nicotine Dependence Behavioral: Incentives for abstinence and treatment engagement Behavioral: Attendance incentive Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569490


Locations
United States, Wisconsin
Wisconsin Women's Health Foundation
Madison, Wisconsin, United States, 53713
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Timothy B. Baker, PhD University of Wisconsin, Madison

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01569490     History of Changes
Other Study ID Numbers: 2012-0136
First Posted: April 3, 2012    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders