- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02421224
Social and Monetary Incentives for Smoking Cessation at Large Employers (SMILE)
3. prosince 2020 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Typ studie
Intervenční
Zápis (Aktuální)
4190
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
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Bangkok, Thajsko
- Mahidol University
-
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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.
|
|
Experimentální: 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.
|
|
Experimentální: 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.
|
|
Experimentální: 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.
|
|
Experimentální: 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.
|
|
Experimentální: 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.
|
|
Experimentální: 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.
|
|
Experimentální: 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.
|
|
Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Proportion of Participants With Smoking Abstinence at 12 Months
Časové okno: 12 months after enrollment
|
7-day point prevalence of abstinence measured 12 months after enrollment using self-reported abstinence and urine cotinine test results
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12 months after enrollment
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Proportion of Participants With Smoking Abstinence at 3 Months
Časové okno: 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
|
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Program Acceptance
Časové okno: At 0 months (at enrollment)
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Proportion of eligible smokers who consent to participate in the main intervention
|
At 0 months (at enrollment)
|
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Proportion of Participants With Smoking Abstinence at 6 Months
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: William H. Dow, PhD, University of California, Berkeley
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. dubna 2015
Primární dokončení (Aktuální)
1. srpna 2017
Dokončení studie (Aktuální)
1. srpna 2017
Termíny zápisu do studia
První předloženo
15. dubna 2015
První předloženo, které splnilo kritéria kontroly kvality
15. dubna 2015
První zveřejněno (Odhad)
20. dubna 2015
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
30. prosince 2020
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
3. prosince 2020
Naposledy ověřeno
1. prosince 2020
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- UCaliforniaBerkeley
- 5R01DA035384 (Grant/smlouva NIH USA)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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