NCT00297440

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2006

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

July 23, 2010

Status Verified

July 1, 2010

Enrollment Period

3.4 years

First QC Date

February 27, 2006

Last Update Submit

July 22, 2010

Conditions

Smoking

Keywords

SmokingExerciseAdolescentGirls

Outcome Measures

Primary Outcomes (1)

  • Smoking status

Secondary Outcomes (3)

  • Physical Activity

  • Weight

  • Body image

Interventions

Cognitive-behavioral treatmentBEHAVIORAL
ExerciseBEHAVIORAL

Eligibility Criteria

Age13 Years - 19 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Parental consent will be required for participation in the project

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

SmokingMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Melissa A Napolitano, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 27, 2006

First Posted

February 28, 2006

Study Start

March 1, 2006

Primary Completion

August 1, 2009

Study Completion

August 1, 2011

Last Updated

July 23, 2010

Record last verified: 2010-07

Locations

US(1)