- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02421224
Social and Monetary Incentives for Smoking Cessation at Large Employers (SMILE)
3 grudnia 2020 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
4190
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
-
Bangkok, Tajlandia
- Mahidol University
-
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Proportion of Participants With Smoking Abstinence at 12 Months
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Proportion of Participants With Smoking Abstinence at 3 Months
Ramy czasowe: 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
Ramy czasowe: At 0 months (at enrollment)
|
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
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Główny śledczy: William H. Dow, PhD, University of California, Berkeley
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 kwietnia 2015
Zakończenie podstawowe (Rzeczywisty)
1 sierpnia 2017
Ukończenie studiów (Rzeczywisty)
1 sierpnia 2017
Daty rejestracji na studia
Pierwszy przesłany
15 kwietnia 2015
Pierwszy przesłany, który spełnia kryteria kontroli jakości
15 kwietnia 2015
Pierwszy wysłany (Oszacować)
20 kwietnia 2015
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
30 grudnia 2020
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
3 grudnia 2020
Ostatnia weryfikacja
1 grudnia 2020
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- UCaliforniaBerkeley
- 5R01DA035384 (Grant/umowa NIH USA)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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