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Smoking Cessation for Young Adult Pacific Islanders: Motivating Pacifika Against Cigarettes and Tobacco (MPACT)

2 augustus 2017 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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:

  1. 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.
  2. 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).
  3. 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).
  4. 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.
  5. The tailored intervention program would have greater success at engaging and retaining participants than the standard intervention program.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

278

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • California
      • Claremont, California, Verenigde Staten, 91711
        • Claremont Graduate University
      • Fullerton, California, Verenigde Staten, 92831
        • California State University Fullerton

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 30 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: Motivating Pacifika Against Cigarettes and Tobacco

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:
  • MPACT
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of cigarettes smoked in last 30 days
Tijdsspanne: 8 months
How many cigarettes has the participant smoked in the last 30 days?
8 months
Cigarette smoked in past 7 days
Tijdsspanne: 8 months
Has the participant smoked a cigarette in the past 7 days?
8 months
Cigarette smoked in past 24 hours
Tijdsspanne: 8 months
Has the participant smoked a cigarette in the past 24 hours?
8 months
Expired carbon monoxide (CO)
Tijdsspanne: 8 months
Biomarker validation (expired CO) of self-reported tobacco use
8 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of cigarettes smoked in last 30 days
Tijdsspanne: 2 months
How many cigarettes has the participant smoked in the last 30 days?
2 months
Number of cigarettes smoked in last 30 days
Tijdsspanne: 5 months
How many cigarettes has the participant smoked in the last 30 days?
5 months
Cigarette smoked in past 7 days
Tijdsspanne: 2 months
Has the participant smoked a cigarette in the past 7 days?
2 months
Cigarette smoked in past 7 days
Tijdsspanne: 5 months
Has the participant smoked a cigarette in the past 7 days?
5 months
Cigarette smoked in past 24 hours
Tijdsspanne: 2 months
Has the participant smoked a cigarette in the past 24 hours?
2 months
Cigarette smoked in past 24 hours
Tijdsspanne: 5 months
Has the participant smoked a cigarette in the past 24 hours?
5 months
Expired carbon monoxide (CO)
Tijdsspanne: 2 months
Biomarker validation (expired CO) of self-reported tobacco use
2 months
Expired carbon monoxide (CO)
Tijdsspanne: 5 months
Biomarker validation (expired CO) of self-reported tobacco use
5 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Claremont Graduate University

Medewerkers

National Cancer Institute (NCI)

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 juli 2013

Primaire voltooiing (Werkelijk)

3 december 2014

Studie voltooiing (Werkelijk)

31 mei 2015

Studieregistratiedata

Eerst ingediend

21 juli 2017

Eerst ingediend dat voldeed aan de QC-criteria

1 augustus 2017

Eerst geplaatst (Werkelijk)

3 augustus 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 augustus 2017

Laatste update ingediend die voldeed aan QC-criteria

2 augustus 2017

Laatst geverifieerd

1 augustus 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • U54CA153458 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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