NCT04009590

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
579

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

2.1 years

First QC Date

February 19, 2019

Last Update Submit

January 20, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Mediation effect of predictors of smoking and recently identified predictors of tobacco use

    Up to 6 months

  • Behavior modification

    Up to 6 months

Study Arms (2)

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.

Other: Questionnaire AdministrationBehavioral: Smoking Cessation Intervention

Group II (educational booklet)

ACTIVE COMPARATOR

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

Other: Educational InterventionOther: Questionnaire Administration

Interventions

Read educational booklet

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Group II (educational booklet)

Ancillary studies

GROUP I (Quit4Health)Group II (educational booklet)

Utilize Quit4Health

Also known as: Smoking and Tobacco Use Cessation Interventions
GROUP I (Quit4Health)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Early Intervention, EducationalEducational StatusMethodsSmoking Devices

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco Use

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesSocioeconomic FactorsPopulation CharacteristicsInvestigative TechniquesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Alexander V Prokhorov

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2019

First Posted

July 5, 2019

Study Start

December 10, 2018

Primary Completion

January 19, 2021

Study Completion

January 19, 2021

Last Updated

January 22, 2021

Record last verified: 2021-01

Locations