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Striving to Quit: First Breath (STQ FB)

Primary Purpose

Smoking Cessation, Smoking, Nicotine Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Incentives for abstinence and treatment engagement
Attendance incentive
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Wisconsin Women's Health Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment incentives

Attendance incentive

Arm Description

Incentives for biochemical verification visits, treatment engagement, and abstinence

Incentives for only attending the biochemical verification visits

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Engagement in treatment
The primary analyses will compare number of calls and visits completed.
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.

Full Information

First Posted
March 30, 2012
Last Updated
February 28, 2017
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT01569490
Brief Title
Striving to Quit: First Breath
Acronym
STQ FB
Official Title
Striving to Quit: First Breath Tobacco Cessation Research
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Smoking, Nicotine Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment incentives
Arm Type
Experimental
Arm Description
Incentives for biochemical verification visits, treatment engagement, and abstinence
Arm Title
Attendance incentive
Arm Type
Active Comparator
Arm Description
Incentives for only attending the biochemical verification visits
Intervention Type
Behavioral
Intervention Name(s)
Incentives for abstinence and treatment engagement
Intervention Description
Treatment Incentives - incentives for biochemical verification visits, treatment engagement, and abstinence
Intervention Type
Behavioral
Intervention Name(s)
Attendance incentive
Intervention Description
Attendance Incentives - incentives for only attending the biochemical verification visits
Primary Outcome Measure Information:
Title
Abstinence from smoking
Description
The data will be the biochemically confirmed reports of abstinence for the past 7 days (i.e., 7-day point-prevalence abstinence)
Time Frame
Measured 6 months after births at follow-up assessment
Secondary Outcome Measure Information:
Title
Engagement in treatment
Description
The primary analyses will compare number of calls and visits completed.
Time Frame
Measured 12 months after birth at follow-up assessment
Title
Cost-effectiveness
Description
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.
Time Frame
Measured 12 months after birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy B. Baker, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wisconsin Women's Health Foundation
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53713
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29389142
Citation
Baker TB, Fraser DL, Kobinsky K, Adsit R, Smith SS, Khalil L, Alaniz KM, Sullivan TE, Johnson ML, Fiore MC. A randomized controlled trial of financial incentives to low income pregnant women to engage in smoking cessation treatment: Effects on post-birth abstinence. J Consult Clin Psychol. 2018 May;86(5):464-473. doi: 10.1037/ccp0000278. Epub 2018 Feb 1.
Results Reference
derived

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Striving to Quit: First Breath

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