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

NCT ID: NCT04009590

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

579 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-10

Study Completion Date

2021-01-19

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.

Conditions

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Cigarette Smoking Current Smoker

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Smoking Cessation Intervention

Intervention Type BEHAVIORAL

Utilize Quit4Health

Group II (educational booklet)

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

Group Type ACTIVE_COMPARATOR

Educational Intervention

Intervention Type OTHER

Read educational booklet

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Educational Intervention

Read educational booklet

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Smoking Cessation Intervention

Utilize Quit4Health

Intervention Type BEHAVIORAL

Other Intervention Names

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Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Smoking and Tobacco Use Cessation Interventions

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander V Prokhorov

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

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NCI-2018-03518

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-0186

Identifier Type: OTHER

Identifier Source: secondary_id

R42DA035012

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2018-0186

Identifier Type: -

Identifier Source: org_study_id

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