- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00296101
School-Based Intervention to Increase Physical Activity Among Adolescent Females
Interventions to Increase Adolescent Physical Activity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Physical activity levels decline dramatically during adolescence, particularly among females, with the decline most apparent among African Americans. The health benefits of regular physical activity are well-known; individuals who are active have lower rates of obesity and less incidence of cardiovascular disease. Because physical activity behaviors often develop during childhood, it is important to develop programs specifically for adolescents to encourage them to adopt and maintain a physically active lifestyle. Unfortunately, few programs have been developed that specifically focus on adolescents, and the long-term effectiveness of these programs is unknown. This study will evaluate the effectiveness of a life-skills oriented Comprehensive Physical Activity Program (CAP) at increasing activity levels in adolescents. Participants in the CAP program will develop new behavioral skills, which will assist them to continue a physically active lifestyle once the program ends. The purpose of this study is to compare CAP versus a standard physical education (PE) class at increasing physical activity levels and decreasing cardiovascular risk factors in adolescent African American and Caucasian females.
This study will enroll 9th grade female students who attend a high school in Baltimore, Maryland. They will be randomly assigned to participate in either a standard PE class or CAP. Participants in the CAP program will also receive support from a family member to ensure that they receive encouragement for engaging in exercise. Baseline assessments will include physical activity level; cardiorespiratory fitness; cardiovascular risk factors, including blood pressure, lipoproteins, and body mass index (BMI); and psychosocial factors. Participants will attend follow-up visits at the end of each school year in the 9th, 10th, and 11th grades.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
College Park, Maryland, United States, 20742
- University of Maryland
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Enrolled in 9th grade at the participating high school in Baltimore, Maryland
Exclusion Criteria:
- Has a chronic medical disorder
- Currently taking medications that affect the cardiovascular or metabolic systems (e.g., beta adrenergic blockers)
- Excused from the State of Maryland's PE requirement
- Planning on leaving the area prior to the end of the study
- Has a sibling enrolled in the study
- Pregnant or breast-feeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Physical activity
|
Cardiorespiratory fitness (measured at follow-up evaluation 2 1/2 years after study entry)
|
Secondary Outcome Measures
Outcome Measure |
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Sedentary behaviors
|
Cardiovascular risk factors (measured by blood pressure, lipoproteins, and BMI)
|
Psychosocial factors (measured at follow-up evaluation 2 1/2 years after study entry)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Deborah R. Young, University of Maryland
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 359
- R01HL063861-05 (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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