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A School-Based Osteoporosis Prevention Program for Adolescent Girls

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ClinicalTrials.gov Identifier: NCT00067925
Recruitment Status : Completed
First Posted : September 4, 2003
Last Update Posted : October 19, 2010
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoporosis Behavioral: Incorporating More Physical Activity and Calcium in Teens (IMPACT) Program Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 718 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Incorporating More Physical Activity and Calcium in Teens (IMPACT): A School-Based Osteoporosis Prevention Program for Adolescent Girls
Study Start Date : September 2000
Study Completion Date : June 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Osteoporosis
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 13 Years   (Child)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067925


Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Deanna M Hoelscher, PhD University of Texas-Houston School of Public Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00067925     History of Changes
Other Study ID Numbers: R01HD037767 ( U.S. NIH Grant/Contract )
First Posted: September 4, 2003    Key Record Dates
Last Update Posted: October 19, 2010
Last Verified: August 2003

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

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs