Exercise, Smoking Cessation and Adolescents

July 22, 2010 updated by: Temple University

Exercise to Aid Smoking Cessation in Adolescent Girls

We seek to: 1) conduct the formative work to adapt the cessation materials and exercise protocol from focus on adult women to adolescent girls, and 2) conduct a small randomized pilot trial to determine the preliminary efficacy of the intervention in a sample of adolescent girls. Therefore, this study, will serve as a pilot for a larger clinical trial. Successful smoking cessation in adolescent girls could contribute to the future reduction of chronic disease morbidity and mortality in this group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Approximately 22% of youth currently smoke cigarettes despite the increased risk of cancer and cardiovascular disease associated with cigarette use. Tobacco use continues to be the leading, preventable cause of mortality among US adults. Research has shown that those who smoke their first cigarette between the ages of 14-26 are more likely to become nicotine dependent, and, therefore, more resistant to smoking cessation efforts, than those initiating smoking at a later age. Although the smoking prevalence among girls declined in the 1970's and 1980's, the current smoking rates among high school girls has held constant from 1998 to 2000. Despite the negative health consequences associated with smoking, weight concerns and fear of weight gain have been shown to be associated with the uptake of smoking in girls. Alternatively, exercise has been shown to be a positive health behavior, and can provide the same perceived benefits of smoking: self-esteem, relaxation, weight management. In previous trials in adult women, vigorous intensity exercise has been shown to be effective for aiding with smoking cessation. Therefore, this study will adapt the efficacious group-based cognitive behavioral smoking cessation treatment plus exercise to meet the needs of adolescent girls. This project will consist of two phases. In Phase I of this project, 4 focus groups will be conducted (each consisting of 8-10 adolescent girls) to adapt the intervention. Adaptations will include making the materials, intervention content, and language age-appropriate and relevant for youth. Phase II of the project will consist of a randomized pilot study in which 40 adolescent girls will be randomly assigned to: a) standard cognitive-behavioral smoking cessation plus exercise (CBT+Exercise) or b) standard cessation with equal contact time (Standard+Contact). The sample will be recruited, treated for 12 weeks and followed for 3 months. Smoking cessation outcome (continuous abstinence) will be validated by saliva cotinine. Exercise adherence will be validated by attendance at supervised sessions, and objective monitoring. Secondary analysis of proposed theoretical mediators of behavior change will be conducted, including weight concerns and self-efficacy. The primary hypothesis is that girls in the CBT+Exercise group will have higher quit rates than girls in the Standard+Contact group. In summary, we seek to: 1) conduct the formative work to adapt the cessation materials and exercise protocol from a focus on adult women to adolescent girls, and 2) conduct a small randomized pilot trial to determine the preliminary efficacy of the intervention in a sample of adolescent girls. Therefore, this study will serve as a pilot for a larger clinical trial. Successful smoking cessation in adolescent girls could contribute to the future reduction of chronic disease mortality in this group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • The Miriam Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Parental consent will be required for participation in the project

Exclusion Criteria:

  • For Phase I of the study, we will recruit adolescent girls who report smoking at least 5 cigarettes per day for 6 months. We will recruit approximately 40 girls to participate in one of 4 focus groups. For Phase II, we will recruit adolescent female smokers (n = 40) aged 13-19. Potential participants for Phase II must smoke at least 5 cigarettes per day and be sedentary (i.e., participating in physical activity two days per week or less for 30 minutes or less each day). Other specific eligibility requirements for both phases include: a) having no physical or mental limitations that would restrict their ability to be active or complete study measures; b) passing the Physical Activity Readiness Questionnaire (PAR-Q).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Smoking status

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Weight
Physical Activity
Body image

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Temple University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Melissa A Napolitano, PhD, The Miriam Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2009

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R03CA119712 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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