- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03238456
Smoking Cessation for Young Adult Pacific Islanders: Motivating Pacifika Against Cigarettes and Tobacco (MPACT)
Weaving an Islander Network for Cancer Awareness, Research and Training (WINCART): Technology & Smoking Cessation for Late Adolescent/Young Adult Pacific Islanders
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
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California
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Claremont, California, Spojené státy, 91711
- Claremont Graduate University
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Fullerton, California, Spojené státy, 92831
- California State University Fullerton
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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.
Ostatní jména:
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Žádný zásah: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Number of cigarettes smoked in last 30 days
Časové okno: 8 months
|
How many cigarettes has the participant smoked in the last 30 days?
|
8 months
|
Cigarette smoked in past 7 days
Časové okno: 8 months
|
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
Časové okno: 8 months
|
Has the participant smoked a cigarette in the past 24 hours?
|
8 months
|
Expired carbon monoxide (CO)
Časové okno: 8 months
|
Biomarker validation (expired CO) of self-reported tobacco use
|
8 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Number of cigarettes smoked in last 30 days
Časové okno: 2 months
|
How many cigarettes has the participant smoked in the last 30 days?
|
2 months
|
Number of cigarettes smoked in last 30 days
Časové okno: 5 months
|
How many cigarettes has the participant smoked in the last 30 days?
|
5 months
|
Cigarette smoked in past 7 days
Časové okno: 2 months
|
Has the participant smoked a cigarette in the past 7 days?
|
2 months
|
Cigarette smoked in past 7 days
Časové okno: 5 months
|
Has the participant smoked a cigarette in the past 7 days?
|
5 months
|
Cigarette smoked in past 24 hours
Časové okno: 2 months
|
Has the participant smoked a cigarette in the past 24 hours?
|
2 months
|
Cigarette smoked in past 24 hours
Časové okno: 5 months
|
Has the participant smoked a cigarette in the past 24 hours?
|
5 months
|
Expired carbon monoxide (CO)
Časové okno: 2 months
|
Biomarker validation (expired CO) of self-reported tobacco use
|
2 months
|
Expired carbon monoxide (CO)
Časové okno: 5 months
|
Biomarker validation (expired CO) of self-reported tobacco use
|
5 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- U54CA153458 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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