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- Klinische proef NCT04009590
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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Texas
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Houston, Texas, Verenigde Staten, 77030
- M D Anderson Cancer Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
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: 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.
|
Nevenstudies
Utilize Quit4Health
Andere namen:
|
Actieve vergelijker: Group II (educational booklet)
Participants read an educational booklet about cigarettes and other tobacco products for 1 month.
|
Nevenstudies
Read educational booklet
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Abstinence from tobacco
Tijdsspanne: At 6 months
|
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.
|
At 6 months
|
Susceptibility to tobacco initiation
Tijdsspanne: At 6 months
|
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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Mediation effect of predictors of smoking and recently identified predictors of tobacco use
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Alexander V Prokhorov, M.D. Anderson Cancer Center
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 2018-0186 (Andere identificatie: M D Anderson Cancer Center)
- NCI-2018-03518 (Register-ID: CTRP (Clinical Trial Reporting Program))
- R42DA035012 (Subsidie/contract van de Amerikaanse NIH)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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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