Quit and Fit: Teen Smoking Cessation

NCT ID: NCT01242657

Last Updated: 2017-11-06

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tobacco Use Cessation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Tobacco Use Cessation Youth Tobacco Use Physical Activity Smoking Cessation Intervention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Brief Advice

Standard of care arm with no intervention; includes standard communication regarding youth tobacco cessation such as a brief discussion and printed materials

Group Type NO_INTERVENTION

No interventions assigned to this group

Not On Tobacco (N-O-T) Program

Teens randomized to this arm participated in the N-O-T program, a proven teen cessation program.

Group Type ACTIVE_COMPARATOR

Not On Tobacco (N-O-T) Program

Intervention Type BEHAVIORAL

Not On Tobacco (N-O-T) Program, a proven teen smoking cessation program

Quit & Fit

Teens randomized to this arm participated in the Not On Tobacco (N-O-T) program with an added physical activity module.

Group Type EXPERIMENTAL

Physical Activity Module

Intervention Type BEHAVIORAL

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) Program

Intervention Type BEHAVIORAL

Not On Tobacco (N-O-T) Program, a proven teen smoking cessation program

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Physical Activity Module

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".

Intervention Type BEHAVIORAL

Not On Tobacco (N-O-T) Program

Not On Tobacco (N-O-T) Program, a proven teen smoking cessation program

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects will be eligible to participate in this study if they:

1. Volunteer to participate
2. Are between the ages of 14-18
3. Obtain written parental consent•
4. Provide written assent
5. Report smoking on at least 1 day in the past 30 days
6. Speak and understand English •NOTE: Teens ages 18 or older will provide consent rather than assent. Parental consent will not be required.

Exclusion Criteria

* 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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Penn State University

OTHER

Sponsor Role collaborator

West Virginia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kimberly Horn, EdD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Melissa Taylor, MA

Role: STUDY_DIRECTOR

West Virginia University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

West Virginia University

Morgantown, West Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 11716656 (View on PubMed)

Dino 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.

Reference Type BACKGROUND
PMID: 18286372 (View on PubMed)

Branstetter 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.

Reference Type BACKGROUND
PMID: 18804924 (View on PubMed)

Horn 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.

Reference Type DERIVED
PMID: 23578440 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CDCU48/CCU310821

Identifier Type: -

Identifier Source: org_study_id