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Preventing Osteoporosis in Adolescent Girls

NCT ID: NCT00069173

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Brief Summary

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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

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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.

Conditions

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Osteoporosis

Keywords

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Females Sedentary School-based

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Project FAB (Fitness and Bone)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role lead

Principal Investigators

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Margaret S. Jamner, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California at Irvine

Locations

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University of California at Irvine

Irvine, California, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Lisa Bouchard, MA

Role: primary

Other Identifiers

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R01HD037746

Identifier Type: NIH

Identifier Source: org_study_id

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