Quit4Health Intervention in Supporting Smoking Cessation and Preventing Smoking Initiation in Young Adults
Quit4Health: Expanding the Reach of an Innovative Tobacco Control Program for Young Adults
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
PRIMARY OBJECTIVES:
I. To evaluate whether smokers randomized to Quit4Health are more likely to quit smoking and remain tobacco-free at 6 months than subjects randomized to the education only control group.
II. To evaluate whether non-smokers who are randomized to Quit4Health are less likely to initiate tobacco usage and remain tobacco-free at 6 months than non-smokers randomized to the education only control group.
SECONDARY OBJECTIVES:
I. To evaluate whether well-established predictors of susceptibility and barriers to cessation (e.g. self-efficacy, knowledge about associated risks, normative beliefs, attitudes, resistance skills, peer pressure) and recently identified predictors of tobacco use (e.g., depression, nicotine dependence, alcohol use, risk-taking propensity) will mediate the effect of the intervention on both onset (for non-smokers) and cessation (for smokers) of tobacco use.
II. To evaluate whether, at the end-of-treatment (EOT) assessment, participants (both smokers and non-smokers) in Quit4Health will report a significantly better perception of Quit4Health (message relevance, tailoring to specific needs based on tobacco use status, motivation to quit, etc.) compared with their counterparts in the education only control arm.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants utilize Quit4Health intervention that includes interactive features, coping strategies and games related to cigarettes and other tobacco products for 1 month.
GROUP II: Participants read an educational booklet about cigarettes and other tobacco products for 1 month.
After completion of study, participants are followed at 3 and 6 months.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Texas
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Houston, Texas, Forente stater, 77030
- M D Anderson Cancer Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Be enrolled in at least one class at Houston Community College (HCC) Central campus, West Loop campus or Spring Branch campus (cessation and prevention/advocacy groups)
- Speak and read English (cessation and prevention/advocacy groups)
- Own an Android or iOS smartphone (cessation and prevention/advocacy groups)
- Provide current and relevant contact information (cessation and prevention/advocacy groups)
- Smoked at least one cigarette (or more) in the past 30 days (cessation group)
- Have data and wifi capabilities on their mobile device (cessation and prevention/advocacy groups)
- Evidence of smoking susceptibility as defined by the Smoking Susceptibility Scale (prevention/advocacy groups)
Exclusion Criteria:
- People who score 16 or above on the Center for Epidemiologic Studies Depression (CESD) thus showing evidence of major depressive disorder (cessation and prevention/advocacy groups)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: GROUP I (Quit4Health)
Participants utilize Quit4Health intervention that includes interactive features, coping strategies and games related to cigarettes and other tobacco products for 1 month.
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Hjelpestudier
Utilize Quit4Health
Andre navn:
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Aktiv komparator: Group II (educational booklet)
Participants read an educational booklet about cigarettes and other tobacco products for 1 month.
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Hjelpestudier
Read educational booklet
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Abstinence from tobacco
Tidsramme: At 6 months
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Any abstinence is defined as "subjective reports of abstinence from tobacco for at least 24 hours or more in the past 30 days", the 7-day point prevalence of abstinence at follow-ups will be verified by measurement of saliva cotinine.
The primary analysis will compare the abstinence rates at 6 months in the control and treatment group using a 2-sample test of proportion for all smokers.
A secondary analysis will involve a simple post-test analysis among smokers using logistic regression.
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At 6 months
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Susceptibility to tobacco initiation
Tidsramme: At 6 months
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Will assess susceptibility to smoking using the measure proposed by Pierce and colleagues.
Will employ similar analytic methods as in primary objective 1 to evaluate the prevalence of susceptibility at the 6-month follow-up in subjects randomized to the experimental intervention condition with respect to subjects assigned to the control condition.
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At 6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Mediation effect of predictors of smoking and recently identified predictors of tobacco use
Tidsramme: Up to 6 months
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The mediation effect estimate will be computed as the product of the effect of the treatment on the mediators and the mediators on the outcome controlling for the treatment.
The Bayesian mediation analysis method detailed by Yuan and MacKinnon will be used to estimate and make inference on the mediation effect.
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Up to 6 months
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Behavior modification
Tidsramme: Up to 6 months
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Will evaluate the motivational appeal, educational relevance and knowledge acquired in specific modules of the app that lead to behavior modification.
Similar assessments will be done among participants in the control condition with educational materials.
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Up to 6 months
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Alexander V Prokhorov, M.D. Anderson Cancer Center
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
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
- 2018-0186 (Annen identifikator: M D Anderson Cancer Center)
- NCI-2018-03518 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- R42DA035012 (U.S. NIH-stipend/kontrakt)
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