- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02207036
Tobacco Status Project: Social Media Intervention for Young Adult Smokers (TSP)
Social Media Intervention for Young Adult Smokers
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Participants will be randomized to one of two conditions: (1) a Facebook-delivered intervention tailored to readiness to quit smoking; or (2) the control condition (referral to the Smokefree.gov website). The intervention will include 12 weeks of Facebook-based messages and activities tailored to participants' stage of change.
Assessments will occur at baseline, 3, 6, and 12 months follow-up. Assessments will include measures on smoking patterns and thoughts about abstinence. All participants who report no past 7-day smoking will be asked to give biochemical verification of smoking status with saliva cotinine test kits that will be mailed to participants.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
California
-
San Francisco, California, Forenede Stater, 94143
- University of California San Francisco Department of Psychiatry
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- ages 18-25 years old
- english literate
- have access to Smartphone or computer with camera
- indicate they go on Facebook "most" (≥ 4) days per week
- have smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 3 or more days of the week
Exclusion Criteria:
- do not read English
- younger than 18 or older than 25 years of age
- do not have access to a Smartphone or computer with a camera
- only go on Facebook 3 or fewer days a week
- have smoked less than 100 cigarettes in their lifetime or do not currently smoke at least 1 cigarette per day on 3 or more days of the week
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Facebook intervention
Assignment to private group on Facebook with 3 months of content delivered to the group.
|
90 days of Facebook messaging, weekly Ask the Doctor sessions
|
|
Aktiv komparator: Referral
Referral to smokefree.gov
website
|
referral to the NCI Smokefree.gov
website
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
7-dages punktprævalens abstinens ved 3 måneder
Tidsramme: 3 måneder efter baseline
|
Indberetninger om forbud mod rygning i de 7 dage forud for 3 måneders vurderingen.
Biokemisk verifikation af abstinens vil også blive registreret.
|
3 måneder efter baseline
|
|
7-dages punktprævalens abstinens ved 6 måneder
Tidsramme: 6 måneder efter baseline
|
Indberetninger om forbud mod rygning i de 7 dage forud for 6 måneders vurderingen.
Biokemisk verifikation af abstinens vil også blive registreret.
|
6 måneder efter baseline
|
|
7-day point prevalence abstinence at 12 months
Tidsramme: 12 months post baseline
|
Reports of no smoking in the 7 days prior to the 12 month assessment.
Biochemical verification of abstinence will also be recorded.
|
12 months post baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Reduction in cigarettes smoked by at least 50% between Baseline and each follow-up timepoint
Tidsramme: 3, 6, and 12 months post baseline
|
Reduction will be assessed at 3, 6, and 12 month follow-ups.
|
3, 6, and 12 months post baseline
|
|
Quit attempts
Tidsramme: 3, 6, and 12 month post-baseline
|
Quit attempt during the follow-up period at 3, 6, and 12 months post-baseline.
|
3, 6, and 12 month post-baseline
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Health risk behaviors
Tidsramme: 3, 6, and 12 months post baseline
|
We will assess prevalence rates of health risk behaviors other than smoking including recent alcohol and illicit drug use, poor sleep quality, sedentary behavior, poor diet, depression, and high risk sexual behavior.
|
3, 6, and 12 months post baseline
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Danielle A Ramo, PhD, University of California, San Francisco
Publikationer og nyttige links
Generelle publikationer
- Ramo DE, Thrul J, Chavez K, Delucchi KL, Prochaska JJ. Feasibility and Quit Rates of the Tobacco Status Project: A Facebook Smoking Cessation Intervention for Young Adults. J Med Internet Res. 2015 Dec 31;17(12):e291. doi: 10.2196/jmir.5209.
- Ramo DE, Thrul J, Delucchi KL, Ling PM, Hall SM, Prochaska JJ. The Tobacco Status Project (TSP): Study protocol for a randomized controlled trial of a Facebook smoking cessation intervention for young adults. BMC Public Health. 2015 Sep 15;15:897. doi: 10.1186/s12889-015-2217-0.
- Ramo DE, Liu H, Prochaska JJ. A mixed-methods study of young adults' receptivity to using Facebook for smoking cessation: if you build it, will they come? Am J Health Promot. 2015 Mar-Apr;29(4):e126-35. doi: 10.4278/ajhp.130326-QUAL-128. Epub 2014 Feb 27.
- Ramo DE, Rodriguez TM, Chavez K, Sommer MJ, Prochaska JJ. Facebook Recruitment of Young Adult Smokers for a Cessation Trial: Methods, Metrics, and Lessons Learned. Internet Interv. 2014 Apr;1(2):58-64. doi: 10.1016/j.invent.2014.05.001.
- Ramo DE, Thrul J, Vogel EA, Delucchi K, Prochaska JJ. Multiple Health Risk Behaviors in Young Adult Smokers: Stages of Change and Stability over Time. Ann Behav Med. 2020 Jan 24;54(2):75-86. doi: 10.1093/abm/kaz025.
- McKelvey K, Ramo D. Conversation Within a Facebook Smoking Cessation Intervention Trial For Young Adults (Tobacco Status Project): Qualitative Analysis. JMIR Form Res. 2018 Sep 4;2(2):e11138. doi: 10.2196/11138.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- A119678
- 5K23DA032578 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Facebook intervention
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Universidad Peruana Cayetano HerediaUkendt
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Washington University School of MedicineNational Institute of Mental Health (NIMH)Afsluttet
-
University of Prince Edward IslandAfsluttetStillesiddende livsstil | At spise | SultCanada
-
Johns Hopkins UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) og andre samarbejdspartnereAktiv, ikke rekrutterendeNyresygdomme | NyresvigtForenede Stater
-
The Cleveland ClinicSigma Theta Tau International Honor Society of NursingAfsluttetHjerte-kar-sygdommeForenede Stater
-
Medical University of South CarolinaAfsluttetAutismespektrumforstyrrelseForenede Stater
-
Instituto de Cardiologia do Rio Grande do SulIrmandade Santa Casa de Misericórdia de Porto AlegreAfsluttetNyretransplantation | UddannelseBrasilien
-
Hospital San Jose Tec de MonterreyAfsluttetFedme | OvervægtigMexico
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Washington University School of MedicineNational Cancer Institute (NCI)AfsluttetSmerte | KræftForenede Stater