- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01982825
Innovative Web-Based Intervention for Smoking Cessation Among College Students
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tobacco use is the leading cause of cancer death. Because smokers who quit by 30 have cancer death risk similar to non-smokers, promoting cessation early in life is critical. U.S. colleges/universities, enrolling >14 million students/year (40% of those aged 18 to 24), are an important venue to reach young adult smokers. While daily tobacco use in the U.S. has declined to 18.1%, nondaily smoking (smoking on some days but not every day) is increasing, particularly among young adults and African Americans. Moreover, young smokers and nondaily smokers (half of young adult smokers9), respectively, are less likely to seek help in quitting; thus, innovative strategies are needed to assist cessation early in life, particularly among those who may not be motivated to quit or seek help. Unfortunately, no research has focused on developing a cessation intervention that addresses a broad range of smoking patterns (nondaily to daily smoking) or diverse campus settings among ethnically diverse student populations. Web-based interventions offer promise in helping college students to quit, given high rates of Internet use and web capacity to provide tailored cessation messages. A novel approach to delivering cessation information might be to address broader lifestyle issues and apply market research strategies such as those used by the tobacco industry to identify market segments of smokers (groups of people with similar interests, goals, values) in order to target and engage these groups more effectively. Applying this strategy to an online cessation intervention should enhance both intervention use and processing of intervention messages, leading to greater abstinence rates.
Our specific aims are:
- Aim 1: To develop and refine a tailored web-based intervention for smoking cessation targeting young adults representing a range of sociodemographic backgrounds, particularly including those from low SES and African American backgrounds, and a range of smoking levels (i.e., nondaily, low-level smokers to daily, heavy smokers) attending college.
- Aim 2: To test the usability, acceptability, and feasibility of the intervention among a sample of college student smokers.
- Aim 3: To determine the potential effect of the intervention on smoking cessation, smoking level, quit attempts, and contextual factors (e.g., mood, alcohol use, social factors) among a sample of college student smokers from various backgrounds and smoking patterns.
This research will be addressed through three phases. Phase 1 will involve the development of the web-site infrastructure, securing incentives, developing website content (dramas, stories), and developing the tailored feedback infrastructure. Phase 2 will involve expert feedback, which will be integrated into the next program version. Phase 3 involves a 6-week trial among a small sample of young adults at two college campuses (university; community/technical college) in Georgia (N = 200). At end-of-intervention, we will assess usability, acceptability, and feasibility of the program; smoking status and level; and psychosocial factors related to smoking (e.g. alcohol use, mood). Assessments of smoking status/level and psychosocial factors will also be conducted at 6 weeks post-intervention. The primary outcomes in the trial are usability, acceptability, and feasibility (self-reported and observed website utilization [check-in, activity]). Secondary outcomes include: (1) message processing (self-reported attention to messages, perceived relevance, and other message use items);19 (2) 7-day and 30-day point prevalence abstinence at end-of-treatment (6 weeks) and at 6-week follow-up (12 weeks) in order to appropriately examine cessation among daily and nondaily smokers; (3) smoking level at 6 and 12 weeks; (4) number of quit attempts since baseline; and (5) change in other contextual factors (mood, alcohol use, social aspects).
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
Georgia
-
Atlanta, Georgia, Stati Uniti, 30322
- Emory University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- age ≥ 18 and less than 30,
- enrolled at least part-time,
- intending to be in one of the two participating schools (Georgia State University, Valdosta State University) for the academic year,
- able to read English, and
- any cigarette smoking in previous 30 days.
Exclusion Criteria:
- Significant mental health problems.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Online intervention arm
Bi-weekly (MTh) for 6 weeks, participants will receive an email asking them to report number of cigarettes smoked, alcoholic drinks, engagement in physical activity, and overall mood the two-three days before.
Upon answering, they will be launched to the site which will contain health messaging focused on smoking and other health topics.
|
See online intervention arm
|
|
Comparatore attivo: Online control arm
Control participants will receive bi-weekly emails (MTh) over 6 weeks but in the context of a standard smoking cessation website.
Because we are primarily testing the check-ins, tailored feedback, and market research-based mini-drama and other web content, we feel that this control group will isolate the hypothesized active elements of our program.
|
See online control arm
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Intervention acceptability
Lasso di tempo: Week 6
|
We will assess the acceptability of the intervention (i.e., reported satisfaction and engagement with the intervention).
|
Week 6
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Cessation
Lasso di tempo: Week 6, Week 12
|
We will assess cessation (self-reported).
|
Week 6, Week 12
|
|
Cigarette consumption
Lasso di tempo: Week 6, Week 12
|
We will assess cigarette consumption to examine changes in consumption over time.
|
Week 6, Week 12
|
|
Quit Attempts
Lasso di tempo: Week 6, Week 12
|
We will assess quit attempts from baseline to follow up.
|
Week 6, Week 12
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- IRB00059657
- 1R43TR000358-01 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Cessazione dell'uso del tabacco
-
Poitiers University HospitalNon ancora reclutamentoTerapia sostitutiva della nicotina | Professionisti sanitari | Desiderio di Tabacco | Tabacco CessationFrancia
Prove cliniche su Online intervention arm
-
University of California, San FranciscoNational Heart, Lung, and Blood Institute (NHLBI); Makerere UniversityNon ancora reclutamentoHIV | Tubercolosi (TBC) | Donne sieropositive incinteUganda
-
Stanford UniversityNational Center for Complementary and Integrative Health (NCCIH)Attivo, non reclutantePrebioticiStati Uniti
-
University of ZurichETH Zurich (Switzerland)Reclutamento
-
Superior UniversityAttivo, non reclutanteArtrosi al ginocchioPakistan
-
Oregon Health and Science UniversityNational Institute of Mental Health (NIMH); University of Connecticut; University... e altri collaboratoriNon ancora reclutamento
-
Instituto de Investigacion Sanitaria La FeMedtronicSconosciuto
-
Tze-Fan ChaoReclutamentoFibrillazione atriale (FA)Taiwan
-
Centre Hospitalier Departemental VendeeCompletato
-
KK Women's and Children's HospitalCompletatoCambio di pesoSingapore
-
Gangnam Severance HospitalReclutamentoTumore gastricoCorea, Repubblica di