Clinical trial NCT01569490: Striving to Quit: First Breath
Official title: Striving to Quit: First Breath Tobacco Cessation Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Smoking
Nicotine Dependence
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2012-04-03
Enrollment: 3100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Abstinence from smoking
timeFrame: Measured 6 months after births at follow-up assessment
Secondary outcomes:
measure: Engagement in treatment
timeFrame: Measured 12 months after birth at follow-up assessment
measure: Cost-effectiveness
timeFrame: Measured 12 months after birth
Other outcomes:
Locations:
city: Madison
country: United States
facility: Wisconsin Women's Health Foundation
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Timothy B. Baker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.