Tobacco Use CessationNCT01242657
Quit and Fit: Teen Smoking Cessation
A study testing Physical Activity Module and Not On Tobacco (N-O-T) Program in people with Tobacco Use Cessation, run by West Virginia University at 1 site in United States.
Trial summary
The long term goal of the study entitled "Quit \& Fit" was to revise, evaluate, and disseminate the American Lung Association´s (ALA) teen smoking cessation program called Not On Tobacco (N-O-T), with an added physical activity module. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- Physical Activity Module and Not On Tobacco (N-O-T) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Mar 2009
- 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 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects will be eligible to participate in this study if they:
- Volunteer to participate
- Are between the ages of 14-18
- Obtain written parental consent•
- Provide written assent
- Report smoking on at least 1 day in the past 30 days
- Speak and understand English •NOTE: Teens ages 18 or older will provide consent rather than assent. Parental consent will not be required.
Who cannot join
- WV high schools will be excluded from participating in the research study if school enrollment does not meet or exceed 300 students in grades 9-12.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University
Morgantown, West Virginia, 26506
About this study
Official title: Quit and Fit: Exploring the Effects of Physical Activity on Teen Smoking Cessation
The long term goal of the study entitled "Quit \& Fit" was to revise, evaluate, and disseminate the American Lung Association´s (ALA) teen smoking cessation program called Not On Tobacco (N-O-T), with an added physical activity module. The physical activity module was intended to encourage youth to adopt a more physically active lifestyle. Research showed that physical activity may increase the odds of smoking cessation. The general N-O-T program goals are to help adolescents quit smoking; reduce cigarette use (for participants who are unable to completely quit); increase healthy lifestyle behaviors; and improve life skills such as stress management, decision making, communication, and interpersonal skills. The primary aim of the current research project was to reduce smoking among West Virginia teens. A two-prong secondary aim was to (a) increase participants´ physical activity behavior by supplementing the intervention with a physical activity component and (b) assess the mediating/moderating impact of physical activity on cessation outcomes. If participants quit smoking, the likelihood that they will develop smoking-related diseases is diminished. Participating in this project may aid smoking cessation and therefore improve participants´ health. Research was conducted among 19 of the 123 West Virginia public high schools. 236 teens were recruited to participate in the study over 3 years. This study is a clinical behavioral trial using a 3-group design, with subsequent random assignment.
- Conditions
- Tobacco Use Cessation
- Being tested
- Physical Activity Module, Not On Tobacco (N-O-T) Program
- Keywords
- Tobacco Use Cessation, Youth Tobacco Use, Physical Activity, Smoking Cessation Intervention
- Medical subject headings
- Tobacco Use Cessation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity ModuleBehavioural
Participants were provided pedometers in order to track specific "Step Goals", which were defined for male or female participants. In addition, each participant recorded other forms of physical activity in a "Challenge Log".
Not On Tobacco (N-O-T) ProgramBehavioural
Not On Tobacco (N-O-T) Program, a proven teen smoking cessation program
| Study group | Role | What they receive |
|---|---|---|
| Brief Advice | No intervention | Standard of care arm with no intervention; includes standard communication regarding youth tobacco cessation such as a brief discussion and printed materials |
| Not On Tobacco (N-O-T) Program | Active comparator | Teens randomized to this arm participated in the N-O-T program, a proven teen cessation program. Receives: Behavioral: Not On Tobacco (N-O-T) Program |
| Quit & Fit | Experimental | Teens randomized to this arm participated in the Not On Tobacco (N-O-T) program with an added physical activity module. Receives: Behavioral: Physical Activity Module; Behavioral: Not On Tobacco (N-O-T) Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation: quit and reduction rates
The primary aim of the current research project is to reduce smoking among West Virginia teens.
Measured: 6 months
Secondary outcomes (2)
Participants´ physical activity behavior
Increase participants´ physical activity behavior by supplementing the intervention with a physical activity component.
Measured: 6 months
Impact of physical activity on cessation outcomes
Assess the mediating/moderating impact of physical activity on cessation outcomes.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startOct 2006
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University
- Responsible party
- Sponsor
- Investigators
- Kimberly Horn, EdD, Principal investigator, West Virginia UniversityMelissa Taylor, MA, Study director, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242657
- Sponsor's protocol ID
- CDCU48/CCU310821
- Status last verified
- Oct 2017
- First submitted
- 11 Nov 2010
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Dino G, Horn K, Goldcamp J, Fernandes A, Kalsekar I, Massey C. A 2-year efficacy study of Not On Tobacco in Florida: an overview of program successes in changing teen smoking behavior. Prev Med. 2001 Dec;33(6):600-5. doi: 10.1006/pmed.2001.0932.
PubMed 11716656Dino G, Horn K, Abdulkadri A, Kalsekar I, Branstetter S. Cost-effectiveness analysis of the Not On Tobacco program for adolescent smoking cessation. Prev Sci. 2008 Mar;9(1):38-46. doi: 10.1007/s11121-008-0082-0. Epub 2008 Feb 20.
PubMed 18286372Branstetter SA, Horn K, Dino G, Zhang J. Beyond quitting: predictors of teen smoking cessation, reduction and acceleration following a school-based intervention. Drug Alcohol Depend. 2009 Jan 1;99(1-3):160-8. doi: 10.1016/j.drugalcdep.2008.07.011. Epub 2008 Sep 19.
PubMed 18804924Horn K, Branstetter S, Zhang J, Jarrett T, Tompkins NO, Anesetti-Rothermel A, Olfert M, Richards T, Dino G. Understanding physical activity outcomes as a function of teen smoking cessation. J Adolesc Health. 2013 Jul;53(1):125-31. doi: 10.1016/j.jadohealth.2013.01.019. Epub 2013 Apr 9.
PubMed 23578440
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quit and Fit: Exploring the Effects of Physical Activity on Teen Smoking Cessation
- ClinicalTrials.gov ID
- NCT01242657
- Acronym / sponsor ID
- CDCU48/CCU310821
- Conditions
- Tobacco Use Cessation
- Keywords
- Tobacco Use Cessation, Youth Tobacco Use, Physical Activity, Smoking Cessation Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- Penn State University
- Study start
- Oct 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 17 Nov 2010 (estimated)
- 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.
The long term goal of the study entitled "Quit \& Fit" was to revise, evaluate, and disseminate the American Lung Association´s (ALA) teen smoking cessation program called Not On Tobacco (N-O-T), with an added physical activity module. The physical activity module was intended to encourage youth to adopt a more physically active lifestyle. Research showed that physical activity may increase the odds of smoking cessation. The general N-O-T program goals are to help adolescents quit smoking; reduce cigarette use (for participants who are unable to completely quit); increase healthy lifestyle behaviors; and improve life skills such as stress management, decision making, communication, and interpersonal skills. The primary aim of the current research project was to reduce smoking among West Virginia teens. A two-prong secondary aim was to (a) increase participants´ physical activity behavior by supplementing the intervention with a physical activity component and (b) assess the mediating/moderating impact of physical activity on cessation outcomes. If participants quit smoking, the likelihood that they will develop smoking-related diseases is diminished. Participating in this project may aid smoking cessation and therefore improve participants´ health. Research was conducted among 19 of the 123 West Virginia public high schools. 236 teens were recruited to participate in the study over 3 years. This study is a clinical behavioral trial using a 3-group design, with subsequent random assignment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brief Advice | No intervention | –Standard of care arm with no intervention; includes standard communication regarding youth tobacco cessation such as a brief discussion and printed materials |
| Not On Tobacco (N-O-T) Program | Active comparator | Behavioral: Not On Tobacco (N-O-T) ProgramTeens randomized to this arm participated in the N-O-T program, a proven teen cessation program. |
| Quit & Fit | Experimental | Behavioral: Physical Activity Module, Behavioral: Not On Tobacco (N-O-T) ProgramTeens randomized to this arm participated in the Not On Tobacco (N-O-T) program with an added physical activity module. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Subjects will be eligible to participate in this study if they:
Key exclusion criteria (1 listed)
- WV high schools will be excluded from participating in the research study if school enrollment does not meet or exceed 300 students in grades 9-12.
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 |
|---|---|---|
| Physical Activity ModuleParticipants were provided pedometers in order to track specific "Step Goals", which were defined for male or female participants. In addition, each participant recorded other forms of physical activity in a "Challenge Log". | Behavioural | Quit & Fit |
| Not On Tobacco (N-O-T) ProgramNot On Tobacco (N-O-T) Program, a proven teen smoking cessation program | Behavioural | Not On Tobacco (N-O-T) Program, Quit & Fit |
Primary outcome
Smoking cessation: quit and reduction rates
Time frame: 6 months
The primary aim of the current research project is to reduce smoking among West Virginia teens.
2 secondary outcomes
Participants´ physical activity behavior
Time frame: 6 months
Impact of physical activity on cessation outcomes
Time frame: 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 6 Nov 2017.
- Background: PubMed 11716656Dino G, Horn K, Goldcamp J, Fernandes A, Kalsekar I, Massey C. A 2-year efficacy study of Not On Tobacco in Florida: an overview of program successes in changing teen smoking behavior. Prev Med. 2001 Dec;33(6):600-5. doi: 10.1006/pmed.2001.0932.
- Background: PubMed 18286372Dino G, Horn K, Abdulkadri A, Kalsekar I, Branstetter S. Cost-effectiveness analysis of the Not On Tobacco program for adolescent smoking cessation. Prev Sci. 2008 Mar;9(1):38-46. doi: 10.1007/s11121-008-0082-0. Epub 2008 Feb 20.
- Background: PubMed 18804924Branstetter SA, Horn K, Dino G, Zhang J. Beyond quitting: predictors of teen smoking cessation, reduction and acceleration following a school-based intervention. Drug Alcohol Depend. 2009 Jan 1;99(1-3):160-8. doi: 10.1016/j.drugalcdep.2008.07.011. Epub 2008 Sep 19.
- Derived from this study: PubMed 23578440Horn K, Branstetter S, Zhang J, Jarrett T, Tompkins NO, Anesetti-Rothermel A, Olfert M, Richards T, Dino G. Understanding physical activity outcomes as a function of teen smoking cessation. J Adolesc Health. 2013 Jul;53(1):125-31. doi: 10.1016/j.jadohealth.2013.01.019. Epub 2013 Apr 9.
- Individual participant dataSharing planned: No
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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.
Kimberly Horn, EdD principal investigator
West Virginia University
Melissa Taylor, MA study director
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Module and Not On Tobacco (N-O-T) Program in people with Tobacco Use Cessation, run by West Virginia University 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 6 Nov 2017. 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?
Smoking cessation: quit and reduction rates (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01242657, which also lists 4 linked publications.
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 6 Nov 2017.