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Preventing Osteoporosis in Adolescent Girls

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ClinicalTrials.gov Identifier: NCT00069173
Recruitment Status : Unknown
Verified June 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Recruiting
First Posted : September 17, 2003
Last Update Posted : June 24, 2005
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoporosis Behavioral: Project FAB (Fitness and Bone) Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Osteoporosis Among Sedentary Adolescent Females
Study Start Date : July 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00069173

United States, California
University of California at Irvine Recruiting
Irvine, California, United States, 92697
Contact: Lisa Bouchard, MA    714-456-2279    lbouchar@uci.edu   
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Margaret S. Jamner, PhD University of California at Irvine
More Information

ClinicalTrials.gov Identifier: NCT00069173     History of Changes
Other Study ID Numbers: R01HD037746 ( U.S. NIH Grant/Contract )
First Posted: September 17, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 2003

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases