Cigarette SmokingNCT04009590
Quit4Health Intervention in Supporting Smoking Cessation and Preventing Smoking Initiation in Young Adults
A study testing Educational Intervention, Questionnaire Administration and Smoking Cessation Intervention in people with Cigarette Smoking and Current Smoker, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking, Current Smoker
- What is being tested?
- Educational Intervention, Questionnaire Administration and Smoking Cessation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 579 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2018to 19 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quit4Health: Expanding the Reach of an Innovative Tobacco Control Program for Young Adults
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Cigarette Smoking, Current Smoker
- Being tested
- Educational Intervention, Questionnaire Administration, Smoking Cessation Intervention
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Read educational booklet
Questionnaire AdministrationOther
Ancillary studies
Smoking Cessation InterventionBehavioural
Also called Smoking and Tobacco Use Cessation Interventions
Utilize Quit4Health
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaire Administration; Behavioral: Smoking Cessation Intervention |
| Group II (educational booklet) | Active comparator | Participants read an educational booklet about cigarettes and other tobacco products for 1 month. Receives: Other: Educational Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start10 Dec 2018
- Primary completion19 Jan 2021
- Study completion19 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 579 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Alexander V Prokhorov, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009590
- Sponsor's protocol ID
- 2018-0186
- Other IDs
- NCI-2018-03518, 2018-0186, R42DA035012
- Status last verified
- Jan 2021
- First submitted
- 19 Feb 2019
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quit4Health: Expanding the Reach of an Innovative Tobacco Control Program for Young Adults
- ClinicalTrials.gov ID
- NCT04009590
- Acronym / sponsor ID
- 2018-0186
- Conditions
- Cigarette Smoking, Current Smoker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 579 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA)
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 19 Jan 2021 (actual)
- Study completion
- 19 Jan 2021 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP I (Quit4Health) | Experimental | Other: Questionnaire Administration, Behavioral: Smoking Cessation InterventionParticipants utilize Quit4Health intervention that includes interactive features, coping strategies and games related to cigarettes and other tobacco products for 1 month. |
| Group II (educational booklet) | Active comparator | Other: Educational Intervention, Other: Questionnaire AdministrationParticipants read an educational booklet about cigarettes and other tobacco products for 1 month. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalRead educational booklet | Other | Group II (educational booklet) |
| Questionnaire AdministrationAncillary studies | Other | GROUP I (Quit4Health), Group II (educational booklet) |
| Smoking Cessation InterventionAlso: Smoking and Tobacco Use Cessation InterventionsUtilize Quit4Health | Behavioural | GROUP I (Quit4Health) |
Primary outcome
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.
2 secondary outcomes
Mediation effect of predictors of smoking and recently identified predictors of tobacco use
Time frame: Up to 6 months
Behavior modification
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander V Prokhorov principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Questionnaire Administration and Smoking Cessation Intervention in people with Cigarette Smoking and Current Smoker, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abstinence from tobacco (time frame: At 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.