Smoking Cessation for Young Adult Pacific Islanders: Motivating Pacifika Against Cigarettes and Tobacco (MPACT)
2. August 2017 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
278
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
California
-
Claremont, California, Vereinigte Staaten, 91711
- Claremont Graduate University
-
Fullerton, California, Vereinigte Staaten, 92831
- California State University Fullerton
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 30 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
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.
Andere Namen:
|
|
Kein Eingriff: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of cigarettes smoked in last 30 days
Zeitfenster: 8 months
|
How many cigarettes has the participant smoked in the last 30 days?
|
8 months
|
|
Cigarette smoked in past 7 days
Zeitfenster: 8 months
|
Has the participant smoked a cigarette in the past 7 days?
|
8 months
|
|
Cigarette smoked in past 24 hours
Zeitfenster: 8 months
|
Has the participant smoked a cigarette in the past 24 hours?
|
8 months
|
|
Expired carbon monoxide (CO)
Zeitfenster: 8 months
|
Biomarker validation (expired CO) of self-reported tobacco use
|
8 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of cigarettes smoked in last 30 days
Zeitfenster: 2 months
|
How many cigarettes has the participant smoked in the last 30 days?
|
2 months
|
|
Number of cigarettes smoked in last 30 days
Zeitfenster: 5 months
|
How many cigarettes has the participant smoked in the last 30 days?
|
5 months
|
|
Cigarette smoked in past 7 days
Zeitfenster: 2 months
|
Has the participant smoked a cigarette in the past 7 days?
|
2 months
|
|
Cigarette smoked in past 7 days
Zeitfenster: 5 months
|
Has the participant smoked a cigarette in the past 7 days?
|
5 months
|
|
Cigarette smoked in past 24 hours
Zeitfenster: 2 months
|
Has the participant smoked a cigarette in the past 24 hours?
|
2 months
|
|
Cigarette smoked in past 24 hours
Zeitfenster: 5 months
|
Has the participant smoked a cigarette in the past 24 hours?
|
5 months
|
|
Expired carbon monoxide (CO)
Zeitfenster: 2 months
|
Biomarker validation (expired CO) of self-reported tobacco use
|
2 months
|
|
Expired carbon monoxide (CO)
Zeitfenster: 5 months
|
Biomarker validation (expired CO) of self-reported tobacco use
|
5 months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
11. Juli 2013
Primärer Abschluss (Tatsächlich)
3. Dezember 2014
Studienabschluss (Tatsächlich)
31. Mai 2015
Studienanmeldedaten
Zuerst eingereicht
21. Juli 2017
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
1. August 2017
Zuerst gepostet (Tatsächlich)
3. August 2017
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
4. August 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
2. August 2017
Zuletzt verifiziert
1. August 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- U54CA153458 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .