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Clinical Trials/NCT04009590
NCT04009590CompletedNot Applicable

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

M.D. Anderson Cancer Center1 site in 1 country579 target enrollmentStarted: December 10, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
579
Locations
1
Primary Endpoint
Abstinence from tobacco

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Arms & Interventions

GROUP I (Quit4Health)

Experimental

Participants utilize Quit4Health intervention that includes interactive features, coping strategies and games related to cigarettes and other tobacco products for 1 month.

Intervention: Questionnaire Administration (Other)

GROUP I (Quit4Health)

Experimental

Participants utilize Quit4Health intervention that includes interactive features, coping strategies and games related to cigarettes and other tobacco products for 1 month.

Intervention: Smoking Cessation Intervention (Behavioral)

Group II (educational booklet)

Active Comparator

Participants read an educational booklet about cigarettes and other tobacco products for 1 month.

Intervention: Educational Intervention (Other)

Group II (educational booklet)

Active Comparator

Participants read an educational booklet about cigarettes and other tobacco products for 1 month.

Intervention: Questionnaire Administration (Other)

Outcomes

Primary Outcomes

Abstinence from tobacco

Time Frame: 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.

Susceptibility to tobacco initiation

Time Frame: 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.

Secondary Outcomes

  • Mediation effect of predictors of smoking and recently identified predictors of tobacco use(Up to 6 months)
  • Behavior modification(Up to 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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