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A School-Based Osteoporosis Prevention Program for Adolescent Girls
This study has been completed.
Study NCT00067925   Information provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First Received: September 3, 2003   Last Updated: March 20, 2008   History of Changes

September 3, 2003
March 20, 2008
September 2000
 
 
 
Complete list of historical versions of study NCT00067925 on ClinicalTrials.gov Archive Site
 
 
 
A School-Based Osteoporosis Prevention Program for Adolescent Girls
Incorporating More Physical Activity and Calcium in Teens (IMPACT): A School-Based Osteoporosis Prevention Program for Adolescent Girls

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.

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.

Phase I
Interventional
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Osteoporosis
Behavioral: Incorporating More Physical Activity and Calcium in Teens (IMPACT) Program
 
Sharma SV, Hoelscher DM, Kelder SH, Day RS, Hergenroeder A. Psychosocial, environmental and behavioral factors associated with bone health in middle-school girls. Health Educ Res. 2009 Apr;24(2):173-84. Epub 2008 Mar 21.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
718
June 2002
 

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
Female
10 Years to 13 Years
Yes
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00067925
 
R01HD37767
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 
Principal Investigator: Deanna M Hoelscher, PhD University of Texas-Houston School of Public Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
August 2003

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