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
  Purpose

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 Intervention Phase
Osteoporosis
Behavioral: Project FAB (Fitness and Bone)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Osteoporosis Among Sedentary Adolescent Females

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 250
Study Start Date: July 2000
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.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00069173

Locations
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
Investigators
Principal Investigator: Margaret S. Jamner, PhD University of California at Irvine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00069173     History of Changes
Other Study ID Numbers: R01HD37746
Study First Received: September 16, 2003
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Females
Sedentary
School-based

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

ClinicalTrials.gov processed this record on April 14, 2014