Striving to Quit: First Breath

NCT ID: NCT01569490

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2016-12-31

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.

Conditions

Smoking Cessation; Smoking; Nicotine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment incentives

Incentives for biochemical verification visits, treatment engagement, and abstinence

Group Type: EXPERIMENTAL

Incentives for abstinence and treatment engagement

Intervention Type: BEHAVIORAL

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

Attendance incentive

Incentives for only attending the biochemical verification visits

Group Type: ACTIVE_COMPARATOR

Attendance incentive

Intervention Type: BEHAVIORAL

Attendance Incentives - incentives for only attending the biochemical verification visits

Interventions

Incentives for abstinence and treatment engagement

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

Intervention Type: BEHAVIORAL

Attendance incentive

Attendance Incentives - incentives for only attending the biochemical verification visits

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy B. Baker, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Wisconsin Women's Health Foundation

Madison, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29389142 (View on PubMed)

Other Identifiers

2012-0136

Identifier Type: -

Identifier Source: org_study_id