Smoking Cessation for Young Adult Pacific Islanders: Motivating Pacifika Against Cigarettes and Tobacco (MPACT)
2. august 2017 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
278
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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Claremont, California, Forente stater, 91711
- Claremont Graduate University
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Fullerton, California, Forente stater, 92831
- California State University Fullerton
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 30 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
Andre navn:
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Ingen inngripen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of cigarettes smoked in last 30 days
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of cigarettes smoked in last 30 days
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 2 months
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Biomarker validation (expired CO) of self-reported tobacco use
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2 months
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Expired carbon monoxide (CO)
Tidsramme: 5 months
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Biomarker validation (expired CO) of self-reported tobacco use
|
5 months
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Samarbeidspartnere og etterforskere
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Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
11. juli 2013
Primær fullføring (Faktiske)
3. desember 2014
Studiet fullført (Faktiske)
31. mai 2015
Datoer for studieregistrering
Først innsendt
21. juli 2017
Først innsendt som oppfylte QC-kriteriene
1. august 2017
Først lagt ut (Faktiske)
3. august 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. august 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. august 2017
Sist bekreftet
1. august 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- U54CA153458 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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.
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