NCT01242657

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2006

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

October 1, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 17, 2010

Completed
Last Updated

November 6, 2017

Status Verified

October 1, 2017

Enrollment Period

2.4 years

First QC Date

November 11, 2010

Last Update Submit

October 31, 2017

Conditions

Keywords

Tobacco Use CessationYouth Tobacco UsePhysical ActivitySmoking Cessation Intervention

Outcome Measures

Primary Outcomes (1)

  • Smoking cessation: quit and reduction rates

    The primary aim of the current research project is to reduce smoking among West Virginia teens.

    6 months

Secondary Outcomes (2)

  • Participants´ physical activity behavior

    6 months

  • Impact of physical activity on cessation outcomes

    6 months

Study Arms (3)

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.

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.

Behavioral: Physical Activity ModuleBehavioral: Not On Tobacco (N-O-T) Program

Interventions

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".

Quit & Fit

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

Not On Tobacco (N-O-T) ProgramQuit & Fit

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Related Publications (4)

  • 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.

    PMID: 11716656BACKGROUND
  • 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.

    PMID: 18286372BACKGROUND
  • 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.

    PMID: 18804924BACKGROUND
  • 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.

MeSH Terms

Conditions

Tobacco Use CessationMotor Activity

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Kimberly Horn, EdD

    West Virginia University

    PRINCIPAL INVESTIGATOR
  • Melissa Taylor, MA

    West Virginia University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2010

First Posted

November 17, 2010

Study Start

October 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

November 6, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations