- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00069173
Preventing Osteoporosis in Adolescent Girls
Prevention of Osteoporosis Among Sedentary Adolescent Females
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Despite the documented health benefits of increased physical activity, there is limited research on behavioral programs designed to increase exercise in adolescents. Psychosocial characteristics, such as self-efficacy for exercise, social support for exercise from family and peers, and perceived benefits of and barriers to exercise, may predispose adolescents toward the adoption and maintenance of physical activity. This study will implement a multifaceted behavioral program specifically designed to increase bone strengthening physical activity by addressing many of the psychosocial factors relating to exercise.
Girls in this study will be enrolled in Project Fitness and Bone (FAB). The Project FAB intervention is delivered during a regular school class period 5 days per week for 10 months. One day per week is devoted to didactic presentations and/or discussion about reasons for being active, ways of overcoming barriers to being active, and strategies for maintaining an active lifestyle. The remaining four days are structured activity sessions, including a range of activities such as modified basketball, aerobic dance, and walking around a track. Primary outcome measures will include bone mass (measured via dual-energy x-ray absorptiometer [DEXA]) and serum and urinary measures of bone formation and resorption. Participants will be contacted by telephone 12 months after their final clinic visit to ascertain their activity level at that time.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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Irvine, California, United States, 92697
- Recruiting
- University of California at Irvine
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Contact:
- Lisa Bouchard, MA
- Phone Number: 714-456-2279
- Email: lbouchar@uci.edu
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Entering the 10th or 11th grade
- Participating in fewer then three vigorous activity sessions per week lasting 20 minutes or more or fewer than five moderate activity sessions per week lasting 30 minutes or more
- At or below the 75 percentile for age- and gender-specific cardiovascular fitness
- Past the age of first menstrual cycle
Exclusion Criteria
- Health problems that would preclude participation in regular exercise
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Investigators
- Principal Investigator: Margaret S. Jamner, PhD, University of California at Irvine
Study record dates
Study Major Dates
Study Start
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
- R01HD037746 (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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