Osteoporosis Clinical Trial
Official title:
Prevention of Osteoporosis Among Sedentary Adolescent Females
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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