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Preventing Osteoporosis in Adolescent Girls

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00069173
First received: September 16, 2003
Last updated: June 23, 2005
Last verified: June 2003

September 16, 2003
June 23, 2005
July 2000
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Complete list of historical versions of study NCT00069173 on ClinicalTrials.gov Archive Site
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Preventing Osteoporosis in Adolescent Girls
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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Osteoporosis
Behavioral: Project FAB (Fitness and Bone)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
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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
Female
13 Years to 17 Years
Yes
United States
 
NCT00069173
R01HD37746
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Margaret S. Jamner, PhD University of California at Irvine
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
June 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP