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Home > "P" Clinical Trials Conditions > Preventing Osteoporosis in Adolescent Girls  Preventing Osteoporosis in Adolescent Girls
Preventing Osteoporosis in Adolescent Girls
For Condition: Osteoporosis
Status: Recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: Physical activity in adolescents is an important part of bone health. Good bone health in adolescents can decrease the risk of osteoporosis. This study will evaluate a program designed to increase the level of physical activity in adolescent girls.
Details: 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.
Eligibility:
Study Type: Interventional, Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 13 Years/17 Years
Genders: Female
Protocol Entry Criteria: 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
Total Enrollment: 250
Location and Contact Information:
Overall Study Official:
MargaretJamner, Principal Investigator, University of California at Irvine
University of California at Irvine *Recruiting*
Irvine, California, 92697
United States
Recruiting Lisa Bouchard 714-456-2279
Additional Information:
Study ID Numbers: R01HD37746;
Study Start Date: July 2000
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069173
Other Osteoporosis Studies:
1. Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis
2. Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer
3. Thalassemia (Cooley's Anemia) Clinical Research Network (TCRN)
4. Treatment of Calcium Deficiency in Young Women
5. A School-Based Osteoporosis Prevention Program for Adolescent Girls
Related Studies:
Other Osteoporosis Clinical Trials
Other California Clinical Trials
Other Irvine Clinical Trials
Preventing Osteoporosis in Adolescent Girls
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