Clinical trial NCT04009590: Quit4Health Intervention in Supporting Smoking Cessation and Preventing Smoking Initiation in Young Adults
Official title: Quit4Health: Expanding the Reach of an Innovative Tobacco Control Program for Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Current Smoker
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institute on Drug Abuse (NIDA)
First posted: 2019-07-05
Enrollment: 579
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Abstinence from tobacco
timeFrame: At 6 months
measure: Susceptibility to tobacco initiation
timeFrame: At 6 months
Secondary outcomes:
measure: Mediation effect of predictors of smoking and recently identified predictors of tobacco use
timeFrame: Up to 6 months
measure: Behavior modification
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Alexander V Prokhorov
role: PRINCIPAL_INVESTIGATOR
References: