Quit4Health Intervention in Supporting Smoking Cessation and Preventing Smoking Initiation in Young Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Quit4Health: Expanding the Reach of an Innovative Tobacco Control Program for Young Adults

Conditions
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Cigarette Smoking, Current Smoker

Intervention / Treatment
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* Other: Educational Intervention
* Other: Questionnaire Administration
* Behavioral: Smoking Cessation Intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GROUP I (Quit4Health)<br>Participants utilize Quit4Health intervention that includes interactive features, coping strategies and games related to cigarettes and other tobacco products for 1 month. | Other: Questionnaire Administration<br>* Ancillary studies<br>Behavioral: Smoking Cessation Intervention<br>* Utilize Quit4Health<br>* Other names: Smoking and Tobacco Use Cessation Interventions;|
| Active Comparator: Group II (educational booklet)<br>Participants read an educational booklet about cigarettes and other tobacco products for 1 month. | Other: Educational Intervention<br>* Read educational booklet<br>* Other names: Intervention, Educational;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |