Cigarette Smoking Clinical Trial
Official title:
Quit4Health: Expanding the Reach of an Innovative Tobacco Control Program for Young Adults
Verified date | January 2021 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial studies how well Quit4Health intervention works in supporting smoking cessation and preventing smoking initiation in young adults. Quit4Health intervention may help young adults learn more about the risks of tobacco use and may help them to quit smoking.
Status | Completed |
Enrollment | 579 |
Est. completion date | January 19, 2021 |
Est. primary completion date | January 19, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Abstinence from tobacco | 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 | |
Primary | Susceptibility to tobacco initiation | 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. | At 6 months | |
Secondary | Mediation effect of predictors of smoking and recently identified predictors of tobacco use | 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. | Up to 6 months | |
Secondary | Behavior modification | 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. | Up to 6 months |
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