Social and Monetary Incentives for Smoking Cessation at Large Employers (SMILE)
2020. december 3. frissítette: 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.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
4190
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Bangkok, Thaiföld
- Mahidol university
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év és régebbi (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Igen
Tanulmányozható nemek
Összes
Leírás
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
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Aktív összehasonlító: 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.
|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Proportion of Participants With Smoking Abstinence at 12 Months
Időkeret: 12 months after enrollment
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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
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Proportion of Participants With Smoking Abstinence at 3 Months
Időkeret: 3 months after enrollment
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7-day point prevalence of abstinence measured 3 months after enrollment based on self-reported abstinence and urine cotinine test results
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3 months after enrollment
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Program Acceptance
Időkeret: At 0 months (at enrollment)
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Proportion of eligible smokers who consent to participate in the main intervention
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At 0 months (at enrollment)
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Proportion of Participants With Smoking Abstinence at 6 Months
Időkeret: 6 months after enrollment
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7-day point prevalence of abstinence measured 6 months after enrollment based on self-reported abstinence and urine cotinine test results
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6 months after enrollment
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: William H. Dow, PhD, University of California, Berkeley
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete
2015. április 1.
Elsődleges befejezés (Tényleges)
2017. augusztus 1.
A tanulmány befejezése (Tényleges)
2017. augusztus 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2015. április 15.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2015. április 15.
Első közzététel (Becslés)
2015. április 20.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2020. december 30.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2020. december 3.
Utolsó ellenőrzés
2020. december 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- UCaliforniaBerkeley
- 5R01DA035384 (Az Egyesült Államok NIH támogatása/szerződése)
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .