Smoking Cessation for Young Adult Pacific Islanders: Motivating Pacifika Against Cigarettes and Tobacco (MPACT)
2 augusti 2017 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
278
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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California
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Claremont, California, Förenta staterna, 91711
- Claremont Graduate University
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Fullerton, California, Förenta staterna, 92831
- California State University Fullerton
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 30 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
Andra namn:
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Inget ingripande: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of cigarettes smoked in last 30 days
Tidsram: 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
Tidsram: 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
Tidsram: 8 months
|
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)
Tidsram: 8 months
|
Biomarker validation (expired CO) of self-reported tobacco use
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8 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of cigarettes smoked in last 30 days
Tidsram: 2 months
|
How many cigarettes has the participant smoked in the last 30 days?
|
2 months
|
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Number of cigarettes smoked in last 30 days
Tidsram: 5 months
|
How many cigarettes has the participant smoked in the last 30 days?
|
5 months
|
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Cigarette smoked in past 7 days
Tidsram: 2 months
|
Has the participant smoked a cigarette in the past 7 days?
|
2 months
|
|
Cigarette smoked in past 7 days
Tidsram: 5 months
|
Has the participant smoked a cigarette in the past 7 days?
|
5 months
|
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Cigarette smoked in past 24 hours
Tidsram: 2 months
|
Has the participant smoked a cigarette in the past 24 hours?
|
2 months
|
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Cigarette smoked in past 24 hours
Tidsram: 5 months
|
Has the participant smoked a cigarette in the past 24 hours?
|
5 months
|
|
Expired carbon monoxide (CO)
Tidsram: 2 months
|
Biomarker validation (expired CO) of self-reported tobacco use
|
2 months
|
|
Expired carbon monoxide (CO)
Tidsram: 5 months
|
Biomarker validation (expired CO) of self-reported tobacco use
|
5 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
11 juli 2013
Primärt slutförande (Faktisk)
3 december 2014
Avslutad studie (Faktisk)
31 maj 2015
Studieregistreringsdatum
Först inskickad
21 juli 2017
Först inskickad som uppfyllde QC-kriterierna
1 augusti 2017
Första postat (Faktisk)
3 augusti 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 augusti 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 augusti 2017
Senast verifierad
1 augusti 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- U54CA153458 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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