|
|
View Clinical Trial (Medical Research Study)
|
Exercise, Smoking Cessation and Adolescents - NCT00297440-02903 (Clinical Trial 138203)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy138203.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Providence |
|
State:
|
|
RI |
| Zip Code: |
|
02903 |
| Conditions: |
|
Smoking |
| Purpose: |
|
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 summary: |
|
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. |
| Criteria: |
|
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 is available at: |
|
The Miriam Hospital
Providence, RI 02903
United States
Primary Contact:
Melissa A Napolitano, PhD
Email: mnapolitano@brown.edu
Phone: 401-793-8160 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 15, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|
|
|
|