Smoking Cessation for Young Adult Pacific Islanders: Motivating Pacifika Against Cigarettes and Tobacco (MPACT)
2 août 2017 mis à jour par: Claremont Graduate University
Weaving an Islander Network for Cancer Awareness, Research and Training (WINCART): Technology & Smoking Cessation for Late Adolescent/Young Adult Pacific Islanders
The current study aimed to test a culturally tailored program designed to help Pacific Islanders (PIs) between the ages of 18 and 30 quit smoking cigarettes by using a randomized controlled trial design with one intervention group and one control group.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
This randomized control trial (RCT) consisted of a baseline assessment (Wave 0) and three follow-up assessments (Waves 1-3). Follow-up assessments were conducted at 2 months, 5 months, and 8 months after the baseline assessment. The objective of the study was to test a culturally-tailored online program designed to help PI young adults quit smoking cigarettes. The online program contained (1) personalized, automated text messages, (2) interactive, online educational modules, and (3) an online forum.
Hypotheses for this study include:
- Participants in the intervention program tailored to PIs would have significantly higher rates of abstinence, lower rates of relapse, and lower smoking frequency and intensity at each follow-up time point than those in the standard intervention program.
- Participants with impaired affective decision capacity (low scores on Iowa Gambling Task (IGT)) would benefit more from the tailored intervention program than participants with normal affective decision capacity (high IGT scores).
- Effects from the tailored intervention program would be more pronounced among participants with particular dispositional phenotypes (depression, hostility, impulsivity) and baseline severity of tobacco addiction (nicotine dependence).
- High-intensity users of the tailored intervention program would be more successful than low intensity users in reducing the frequency and intensity of cigarettes smoked.
- The tailored intervention program would have greater success at engaging and retaining participants than the standard intervention program.
Type d'étude
Interventionnel
Inscription (Réel)
278
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
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California
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Claremont, California, États-Unis, 91711
- Claremont Graduate University
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Fullerton, California, États-Unis, 92831
- California State University Fullerton
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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 à 30 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Self-identified as Native Hawaiian or Pacific Islander
- Between the ages 18 and 30
- Lived in Southern California
- Would be living in Southern California for the next year
- Owned a cell phone with a text messaging plan
- Had access to a computer with internet for at least 2 hours per week
- Smoked daily or most days of the week (>3 days)
- Smoked at least 100 cigarettes in lifetime
Exclusion Criteria:
• Was currently using another smoking cessation method
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: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Intervention
The intervention entitled Motivating Pacifika Against Cigarettes and Tobacco (MPACT) was implemented for eight weeks starting on the quit date that the participant chose with their assigned coach during the baseline assessment.
At the baseline assessment, each participant watched an introductory video that described the online smoking cessation program.
The online program was accessed through the participant's Facebook account.
The program included eight education modules and a forum.
Participants also received automated daily text messages to provide support and encouragement during the quitting process.
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Participants received one encouraging text message per day prior to their quit date. During the intervention, they received daily text messages with decreasing frequency per week. Participants were also able to craft personal text messages. On-demand text messages were optional and could be requested by texting key words to the program hotline. The online MPACT program allowed participants to access eight educational modules and a forum where they could communicate with other participants. The modules focused on different aspects of quitting smoking, such as how to deal with withdrawal symptoms, triggers of tobacco use, and stress. Participants were limited to one module per day in order to increase the duration of exposure to the program. Upon completion, participants no longer received text messages but they were still able to access the educational modules, forum, and on-demand text messages.
Autres noms:
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Aucune intervention: Control
Participants in the control group set a quit date within two weeks of their baseline assessment and watched an introductory video that described the smoking cessation program.
They received one text message every other week over a period of eight weeks following the quit date.
The messages were delivered by a web-based system not connected to the online intervention program.
Participants were also given a handout listing local tobacco cessation and education resources, a link to a generic online smoking cessation program, a fact sheet on smoking and tobacco use among PI young adults, and a quit kit containing chewing gum and a stress ball.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of cigarettes smoked in last 30 days
Délai: 8 months
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How many cigarettes has the participant smoked in the last 30 days?
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8 months
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Cigarette smoked in past 7 days
Délai: 8 months
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Has the participant smoked a cigarette in the past 7 days?
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8 months
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Cigarette smoked in past 24 hours
Délai: 8 months
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Has the participant smoked a cigarette in the past 24 hours?
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8 months
|
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Expired carbon monoxide (CO)
Délai: 8 months
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Biomarker validation (expired CO) of self-reported tobacco use
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8 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of cigarettes smoked in last 30 days
Délai: 2 months
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How many cigarettes has the participant smoked in the last 30 days?
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2 months
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Number of cigarettes smoked in last 30 days
Délai: 5 months
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How many cigarettes has the participant smoked in the last 30 days?
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5 months
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Cigarette smoked in past 7 days
Délai: 2 months
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Has the participant smoked a cigarette in the past 7 days?
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2 months
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Cigarette smoked in past 7 days
Délai: 5 months
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Has the participant smoked a cigarette in the past 7 days?
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5 months
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Cigarette smoked in past 24 hours
Délai: 2 months
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Has the participant smoked a cigarette in the past 24 hours?
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2 months
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Cigarette smoked in past 24 hours
Délai: 5 months
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Has the participant smoked a cigarette in the past 24 hours?
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5 months
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Expired carbon monoxide (CO)
Délai: 2 months
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Biomarker validation (expired CO) of self-reported tobacco use
|
2 months
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Expired carbon monoxide (CO)
Délai: 5 months
|
Biomarker validation (expired CO) of self-reported tobacco use
|
5 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
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 (Réel)
11 juillet 2013
Achèvement primaire (Réel)
3 décembre 2014
Achèvement de l'étude (Réel)
31 mai 2015
Dates d'inscription aux études
Première soumission
21 juillet 2017
Première soumission répondant aux critères de contrôle qualité
1 août 2017
Première publication (Réel)
3 août 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 août 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 août 2017
Dernière vérification
1 août 2017
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- U54CA153458 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
De-identified datasets with individual participant data will be provided by the Principal Investigator upon request.
All data sharing requests will be reviewed and approved by the Office of Research and Sponsored Programs at Claremont Graduate University and the WINCART2 Center Steering Committee.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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 .