Striving to Quit: First Breath (STQ FB)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Wisconsin, Madison
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01569490
First received: March 30, 2012
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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 Intervention
Smoking Cessation
Smoking
Nicotine Dependence
Behavioral: Incentives for abstinence and treatment engagement
Behavioral: Attendance incentive

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Striving to Quit: First Breath Tobacco Cessation Research

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Abstinence from smoking [ Time Frame: Measured 6 months after births at follow-up assessment ] [ Designated as safety issue: No ]
    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:
  • Engagement in treatment [ Time Frame: Measured 12 months after birth at follow-up assessment ] [ Designated as safety issue: No ]
    The primary analyses will compare number of calls and visits completed.

  • Cost-effectiveness [ Time Frame: Measured 12 months after birth ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 3100
Study Start Date: September 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01569490

Contacts
Contact: Kate Kobinsky, MPH, CHES 608-265-5617 ks6@ctri.wisc.edu
Contact: Dave Fraser, MS 608-265-4561 dlf@ctri.wisc.edu

Locations
United States, Wisconsin
Wisconsin Women's Health Foundation Recruiting
Madison, Wisconsin, United States, 53713
Contact: Lisette Khalil    608-251-1675    lkhalil@wwhf.org   
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Timothy B. Baker, PhD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01569490     History of Changes
Other Study ID Numbers: 2012-0136
Study First Received: March 30, 2012
Last Updated: July 23, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 16, 2014