Striving to Quit: First Breath (STQ FB)
Striving to Quit: First Breath Tobacco Cessation Research
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Wisconsin
-
Madison, Wisconsin, Forente stater, 53713
- Wisconsin Women's Health Foundation
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Treatment incentives
Incentives for biochemical verification visits, treatment engagement, and abstinence
|
Treatment Incentives - incentives for biochemical verification visits, treatment engagement, and abstinence
|
|
Aktiv komparator: Attendance incentive
Incentives for only attending the biochemical verification visits
|
Attendance Incentives - incentives for only attending the biochemical verification visits
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Abstinence from smoking
Tidsramme: Measured 6 months after births at follow-up assessment
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Engagement in treatment
Tidsramme: Measured 12 months after birth at follow-up assessment
|
The primary analyses will compare number of calls and visits completed.
|
Measured 12 months after birth at follow-up assessment
|
|
Cost-effectiveness
Tidsramme: Measured 12 months after birth
|
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.
|
Measured 12 months after birth
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Timothy B. Baker, PhD, University of Wisconsin, Madison
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2012-0136
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