A School-Based Osteoporosis Prevention Program for Adolescent Girls
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Incorporating More Physical Activity and Calcium in Teens (IMPACT) Program
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis focused on measuring Weight-bearing physical activity, Calcium intake, School-based health education, Adolescent girls, Child nutrition, Diet
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00067925
First Posted
September 3, 2003
Last Updated
October 18, 2010
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00067925
Brief Title
A School-Based Osteoporosis Prevention Program for Adolescent Girls
Official Title
Incorporating More Physical Activity and Calcium in Teens (IMPACT): A School-Based Osteoporosis Prevention Program for Adolescent Girls
Study Type
Interventional
2. Study Status
Record Verification Date
August 2003
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Weight-bearing physical activity, Calcium intake, School-based health education, Adolescent girls, Child nutrition, Diet
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
718 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Incorporating More Physical Activity and Calcium in Teens (IMPACT) Program
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deanna M Hoelscher, PhD
Organizational Affiliation
University of Texas-Houston School of Public Health
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
20497785
Citation
Sharma SV, Hoelscher DM, Kelder SH, Diamond P, Day RS, Hergenroeder A. Psychosocial factors influencing calcium intake and bone quality in middle school girls. J Am Diet Assoc. 2010 Jun;110(6):932-6. doi: 10.1016/j.jada.2010.03.013.
Results Reference
derived
PubMed Identifier
19953837
Citation
Sharma SV, Hoelscher DM, Kelder SH, Diamond PM, Day RS, Hergenroeder AC. A path analysis to identify the psychosocial factors influencing physical activity and bone health in middle-school girls. J Phys Act Health. 2009 Sep;6(5):606-16. doi: 10.1123/jpah.6.5.606.
Results Reference
derived
PubMed Identifier
18359949
Citation
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. doi: 10.1093/her/cyn009. Epub 2008 Mar 21.
Results Reference
derived
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A School-Based Osteoporosis Prevention Program for Adolescent Girls
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