Preventing Osteoporosis in Adolescent Girls - Tabular View

Tracking Information

First Received Date ^ICMJE

September 16, 2003

Last Updated Date

June 23, 2005

Start Date ^ICMJE

July 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00069173 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Preventing Osteoporosis in Adolescent Girls

Official Title ^ICMJE

Prevention of Osteoporosis Among Sedentary Adolescent Females

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Osteoporosis

Intervention ^ICMJE

Behavioral: Project FAB (Fitness and Bone)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

250

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

13 Years to 17 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00069173

Responsible Party

Study ID Numbers ^ICMJE

R01HD37746

Study Sponsor ^ICMJE

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Margaret S. Jamner, PhD

University of California at Irvine

Information Provided By

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Verification Date

June 2003

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