NCT01569490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,100

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 3, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 3, 2017

Status Verified

February 1, 2017

Enrollment Period

3.2 years

First QC Date

March 30, 2012

Last Update Submit

February 28, 2017

Conditions

Smoking CessationSmokingNicotine Dependence

Outcome Measures

Primary Outcomes (1)

  • 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)

    Measured 6 months after births at follow-up assessment

Secondary Outcomes (2)

  • Engagement in treatment

    Measured 12 months after birth at follow-up assessment

  • Cost-effectiveness

    Measured 12 months after birth

Study Arms (2)

Treatment incentives

EXPERIMENTAL

Incentives for biochemical verification visits, treatment engagement, and abstinence

Behavioral: Incentives for abstinence and treatment engagement

Attendance incentive

ACTIVE COMPARATOR

Incentives for only attending the biochemical verification visits

Behavioral: Attendance incentive

Interventions

Incentives for abstinence and treatment engagementBEHAVIORAL

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

Treatment incentives
Attendance incentiveBEHAVIORAL

Attendance Incentives - incentives for only attending the biochemical verification visits

Attendance incentive

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wisconsin Women's Health Foundation

Madison, Wisconsin, 53713, United States

Location

Related Publications (1)

  • 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.

    PMID: 29389142DERIVED

MeSH Terms

Conditions

Smoking CessationSmokingTobacco Use Disorder

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Timothy B. Baker, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2012

First Posted

April 3, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

March 3, 2017

Record last verified: 2017-02

Locations

US(1)