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Social and Monetary Incentives for Smoking Cessation at Large Employers (SMILE)

3 décembre 2020 mis à jour par: 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.

Aperçu de l'étude

Type d'étude

Interventionnel

Inscription (Réel)

4190

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Bangkok, Thaïlande
        • Mahidol University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Expérimental: 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.
Expérimental: 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.
Expérimental: 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.
Expérimental: 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.
Expérimental: 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.
Expérimental: 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.
Expérimental: 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.
Expérimental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Proportion of Participants With Smoking Abstinence at 12 Months
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Proportion of Participants With Smoking Abstinence at 3 Months
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: William H. Dow, PhD, University of California, Berkeley

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2015

Achèvement primaire (Réel)

1 août 2017

Achèvement de l'étude (Réel)

1 août 2017

Dates d'inscription aux études

Première soumission

15 avril 2015

Première soumission répondant aux critères de contrôle qualité

15 avril 2015

Première publication (Estimation)

20 avril 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 décembre 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 décembre 2020

Dernière vérification

1 décembre 2020

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • UCaliforniaBerkeley
  • 5R01DA035384 (Subvention/contrat des NIH des États-Unis)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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