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A School-Based Osteoporosis Prevention Program for Adolescent Girls

This study has been completed.

Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00067925
  Purpose

The Incorporating More Physical Activity and Calcium in Teens (IMPACT) study was a behaviorally-based middle school nutrition and physical activity program for the prevention of osteoporosis. The goal of IMPACT was to increase calcium intake and physical activity to help build bone mass in girls.


Condition Intervention Phase
Osteoporosis
Behavioral: Incorporating More Physical Activity and Calcium in Teens (IMPACT) Program
Phase I

MedlinePlus related topics:   Osteoporosis   

Drug Information available for:   Calcium gluconate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Incorporating More Physical Activity and Calcium in Teens (IMPACT): A School-Based Osteoporosis Prevention Program for Adolescent Girls

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

Estimated Enrollment:   718
Study Start Date:   September 2000
Estimated Study Completion Date:   June 2002

Detailed Description:

Peak bone mass is achieved during the first twenty years of life, and dietary and activity patterns that contribute to the formation of peak bone mass are developed during childhood. The IMPACT intervention was designed to increase bone density and ultimately prevent osteoporosis during adulthood. IMPACT included physical education, food service, and classroom environmental and behavioral components and was delivered by physical education (PE) specialists, food service personnel, and classroom teachers.

A group of 718 sixth grade girls (mean age 11.1) from twelve middle schools in central Texas participated in the study. The group was 72% non-Hispanic white, 12% Hispanic, 5% African American, and 11% other ethnicity. After baseline measurements were completed in the fall of 2000, the twelve middle schools were pair-matched based on school characteristics (ethnicity, % economically disadvantaged, % girls in athletics) to a control (usual health education program) or the IMPACT program. The intervention was implemented for 18 months and consisted of three major components: a PE component, which emphasized daily weight-bearing activities (WBA); a health lessons component consisting of sixteen behaviorally-based lessons which emphasized WBA, calcium-rich foods, and osteoporosis prevention; and a food service component.

Outcome measures included physical properties of the students' heel bones, calcium consumption, physical activity, and psychosocial factors believed to be precursors to these behaviors. Changes at the school environmental level, such as the number of calcium rich foods offered in the cafeteria and the number of opportunities offered for weight-bearing and aerobic activity, were also assessed.

  Eligibility
Ages Eligible for Study:   10 Years to 13 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Girls enrolled in 6th grade of selected schools
  • Student assent
  • Parental consent
  • No fractures or medications that compromise bone health or strength
  • Enrolled in 2 semesters of physical education
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067925

Sponsors and Collaborators

Investigators
Principal Investigator:     Deanna M Hoelscher, PhD     University of Texas-Houston School of Public Health    
  More Information


Web site that includes project protocols, instruments, and publications  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   R01HD37767
First Received:   September 3, 2003
Last Updated:   March 20, 2008
ClinicalTrials.gov Identifier:   NCT00067925
Health Authority:   United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Weight-bearing physical activity  
Calcium intake  
School-based health education  
Adolescent girls
Child nutrition
Diet

Study placed in the following topic categories:
Body Weight
Musculoskeletal Diseases
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on November 30, 2008




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