Overview

This trial is active, not recruiting.

Conditions smoking cessation, smoking, nicotine dependence
Treatments incentives for abstinence and treatment engagement, attendance incentive
Sponsor University of Wisconsin, Madison
Start date September 2012
End date December 2015
Trial size 3100 participants
Trial identifier NCT01569490, 2012-0136

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Incentives for biochemical verification visits, treatment engagement, and abstinence
incentives for abstinence and treatment engagement
Treatment Incentives - incentives for biochemical verification visits, treatment engagement, and abstinence
(Active Comparator)
Incentives for only attending the biochemical verification visits
attendance incentive
Attendance Incentives - incentives for only attending the biochemical verification visits

Primary Outcomes

Measure
Abstinence from smoking
time frame: Measured 6 months after births at follow-up assessment

Secondary Outcomes

Measure
Engagement in treatment
time frame: Measured 12 months after birth at follow-up assessment
Cost-effectiveness
time frame: Measured 12 months after birth

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Striving to Quit: First Breath Tobacco Cessation Research
Principal investigator Timothy B. Baker, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.