Preventing Osteoporosis in Adolescent Girls
Primary Purpose
Osteoporosis
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Project FAB (Fitness and Bone)
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis focused on measuring Females, Sedentary, School-based
Eligibility 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
Sites / Locations
- University of California at IrvineRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00069173
First Posted
September 16, 2003
Last Updated
June 23, 2005
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00069173
Brief Title
Preventing Osteoporosis in Adolescent Girls
Official Title
Prevention of Osteoporosis Among Sedentary Adolescent Females
Study Type
Interventional
2. Study Status
Record Verification Date
June 2003
Overall Recruitment Status
Unknown status
Study Start Date
July 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Females, Sedentary, School-based
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Project FAB (Fitness and Bone)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret S. Jamner, PhD
Organizational Affiliation
University of California at Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California at Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Bouchard, MA
Phone
714-456-2279
Email
lbouchar@uci.edu
12. IPD Sharing Statement
Learn more about this trial
Preventing Osteoporosis in Adolescent Girls
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