- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03002883
STAND Community College Tobacco Cessation Trial
Sacramento Taking Action Against Nicotine Dependence (STAND) at Sacramento City College
Community colleges have 45% of the nation's undergraduates and have a higher smoking prevalence rate than 4-year colleges. California's community colleges comprise the nation's largest higher education system, and Sacramento has the second largest community college district. As more colleges are encouraged to become smoke and tobacco-free campuses, smokers enrolled at community college campuses need greater support. However, community colleges may lack the student health clinic resources that 4-year colleges have for students who live on campus. Little evidence to date demonstrates effective interventions for smokers on community college campuses.
This pilot study seeks to demonstrate the feasibility and promising outcomes of two cessation interventions, compared with usual care on a community college campus. The first intervention was based on a promising model of brief motivational interviewing delivered by peer educators, developed by the community lead Breathe California of Sacramento-Emigrant Trails (BCSET) through the Sacramento Taking Action Against Tobacco Dependence (STAND) project. The second intervention was based on direct enrollment into the California Smokers' Helpline, which has demonstrated utility for promoting smoking cessation among young adults with low socioeconomic status. Usual care consisted of students going to the student health center for smoking cessation assistance.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- adult 18 years or older
- current smoker in the past 30 days
- smoker wants to quit
- smoker not currently participating in other smoking cessation activities, and
- smoker must be willing to accept randomization into any of the 3 study arms
Exclusion Criteria:
- students not proficient in communicating in English
- adults unable to consent
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Placebo komparator: Usual Care
Students referred to student health for tobacco cessation resources including campus "Quit Kits"
|
Participant provided "Quit Kit" water bottle with small cessation aids (eg.
sunflower seeds) and educated about student health as a cessation resource
|
Aktiv komparator: Brief Motivational Interviewing
Students received brief motivational interviewing by a student peer educator about tobacco cessation
|
Participant provided "Quit Kit" water bottle with small cessation aids (eg.
sunflower seeds) and educated about student health as a cessation resource
Peer educator conducts brief motivational interviewing about smoking cessation and participant goals
|
Aktiv komparator: Direct referral to quitline
Students were directly referred to the state quitline for follow-up counseling
|
Participant provided "Quit Kit" water bottle with small cessation aids (eg.
sunflower seeds) and educated about student health as a cessation resource
Peer educator educates about state quitline services and gets verbal consent to use quitline's direct referral web portal for quitline to contact participant in 1-2 business days about free counseling services to make a quit plan
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Biochemically validated smoking cessation
Tidsramme: 6 months
|
Point prevalence abstinence validated by saliva cotinine level
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Self-reported smoking cessation
Tidsramme: 6 months
|
Point prevalence abstinence by self-report on survey
|
6 months
|
Self-reported smoking cessation
Tidsramme: 3 months
|
Point prevalence abstinence by self-report on survey
|
3 months
|
Self-reported smoking cessation
Tidsramme: 1 month
|
Point prevalence abstinence by self-report on survey
|
1 month
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Elisa Tong, MD, University of California, Davis
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 491744
- 22BT-0057 (Annen identifikator: Other)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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