Social and Monetary Incentives for Smoking Cessation at Large Employers (SMILE)
3. desember 2020 oppdatert av: University of California, Berkeley
The investigators will conduct a cluster randomized controlled trial of several behavioral interventions for smoking cessation among a sample of employees at large workplaces in the Bangkok metropolitan area.
The study aims to test the impacts of different incentive structures for smoking cessation on take-up, effectiveness, and cost-effectiveness.
The interventions are designed to elucidate certain principles from the field of behavioral economics.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
4190
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Bangkok, Thailand
- Mahidol University
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Current full-time employee of a participating company
- Smoker of 100+ cigarettes during lifetime
- Smoker of 10+ cigarettes per week
- Individual is aged 18+ years old
- Smoker wants to quit within the next 6 months
Exclusion Criteria:
- Expects to leave company within the next 12 months
- Is currently pregnant
- Are unable to provide informed consent
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Usual Care
Participants will receive in-person group counseling from a trained smoking cessation counselor.
Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt.
Participants will also complete a quit plan.
|
Participants will receive in-person group counseling from a trained smoking cessation counselor.
Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt.
Participants will also complete a quit plan.
|
|
Eksperimentell: Deposits
Same as Usual Care, plus participants will have to deposit a certain amount of their own money as an incentive to quit smoking.
Participants will be able to make additional voluntary deposits above the minimum amount.
The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test.
The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.
|
Participants will receive in-person group counseling from a trained smoking cessation counselor.
Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt.
Participants will also complete a quit plan.
Participants will have to deposit a certain amount of their own money at enrollment.
Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period.
The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test.
The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.
|
|
Eksperimentell: Small Individual Bonus
Same as Usual Care, plus each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test.
|
Participants will receive in-person group counseling from a trained smoking cessation counselor.
Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt.
Participants will also complete a quit plan.
Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test.
|
|
Eksperimentell: Large Individual Bonus
Same as Usual Care, plus each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test.
The bonus is twice the value of that in the Small Individual Bonus group.
|
Participants will receive in-person group counseling from a trained smoking cessation counselor.
Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt.
Participants will also complete a quit plan.
Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test.
The bonus is twice the value of that in the Small Individual Bonus group.
|
|
Eksperimentell: Team Bonus
Same as Usual Care, plus each participant will be randomly assigned one teammate to provide social support during the quit attempt.
If the participant and assigned teammate both quit smoking at 3 months, as verified by a urine cotinine test, then each will receive a monetary bonus.
The team bonus is equal in value to that in the Large Individual Bonus group.
|
Participants will receive in-person group counseling from a trained smoking cessation counselor.
Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt.
Participants will also complete a quit plan.
Each participant will be randomly assigned one teammate to provide social support during the quit attempt.
Each participant will be assigned to a participating coworker who speaks the same primary language and works the same work shift as the participant.
If the participant and assigned teammate both quit smoking at 3 months, as verified by a urine cotinine test, then each will receive a monetary bonus.
The team bonus is equal in value to that in the Large Individual Bonus group.
|
|
Eksperimentell: Deposits plus Small Individual Bonus
Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group and will follow the protocol for the monetary bonus as described for the Small Individual Bonus group.
|
Participants will receive in-person group counseling from a trained smoking cessation counselor.
Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt.
Participants will also complete a quit plan.
Participants will have to deposit a certain amount of their own money at enrollment.
Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period.
The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test.
The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.
Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test.
|
|
Eksperimentell: Deposits plus Large Individual Bonus
Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group and will follow the protocol for the monetary bonus as described for the Large Individual Bonus group.
|
Participants will receive in-person group counseling from a trained smoking cessation counselor.
Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt.
Participants will also complete a quit plan.
Participants will have to deposit a certain amount of their own money at enrollment.
Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period.
The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test.
The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.
Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test.
The bonus is twice the value of that in the Small Individual Bonus group.
|
|
Eksperimentell: Deposits plus Teammate
Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group and will be randomly assigned one other participant to serve as a teammate who provides social support during the quit attempt.
|
Participants will receive in-person group counseling from a trained smoking cessation counselor.
Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt.
Participants will also complete a quit plan.
Participants will have to deposit a certain amount of their own money at enrollment.
Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period.
The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test.
The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.
Each participant will be randomly assigned one teammate to provide social support during the quit attempt.
Each participant will be assigned to a participating coworker who speaks the same primary language and works the same work shift as the participant.
|
|
Eksperimentell: Deposits plus Team Bonus
Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group, will be randomly assigned a teammate, and will follow the protocol for the monetary bonus as described for the Team Bonus group.
|
Participants will receive in-person group counseling from a trained smoking cessation counselor.
Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt.
Participants will also complete a quit plan.
Participants will have to deposit a certain amount of their own money at enrollment.
Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period.
The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test.
The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.
Each participant will be randomly assigned one teammate to provide social support during the quit attempt.
Each participant will be assigned to a participating coworker who speaks the same primary language and works the same work shift as the participant.
If the participant and assigned teammate both quit smoking at 3 months, as verified by a urine cotinine test, then each will receive a monetary bonus.
The team bonus is equal in value to that in the Large Individual Bonus group.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of Participants With Smoking Abstinence at 12 Months
Tidsramme: 12 months after enrollment
|
7-day point prevalence of abstinence measured 12 months after enrollment using self-reported abstinence and urine cotinine test results
|
12 months after enrollment
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of Participants With Smoking Abstinence at 3 Months
Tidsramme: 3 months after enrollment
|
7-day point prevalence of abstinence measured 3 months after enrollment based on self-reported abstinence and urine cotinine test results
|
3 months after enrollment
|
|
Program Acceptance
Tidsramme: At 0 months (at enrollment)
|
Proportion of eligible smokers who consent to participate in the main intervention
|
At 0 months (at enrollment)
|
|
Proportion of Participants With Smoking Abstinence at 6 Months
Tidsramme: 6 months after enrollment
|
7-day point prevalence of abstinence measured 6 months after enrollment based on self-reported abstinence and urine cotinine test results
|
6 months after enrollment
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: William H. Dow, PhD, University of California, Berkeley
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2015
Primær fullføring (Faktiske)
1. august 2017
Studiet fullført (Faktiske)
1. august 2017
Datoer for studieregistrering
Først innsendt
15. april 2015
Først innsendt som oppfylte QC-kriteriene
15. april 2015
Først lagt ut (Anslag)
20. april 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. desember 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. desember 2020
Sist bekreftet
1. desember 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UCaliforniaBerkeley
- 5R01DA035384 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .