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A School-Based Osteoporosis Prevention Program for Adolescent Girls

NCT ID: NCT00067925

Last Updated: 2010-10-19

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

718 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2002-06-30

Brief Summary

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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

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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.

Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Incorporating More Physical Activity and Calcium in Teens (IMPACT) Program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

13 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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Deanna M Hoelscher, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas-Houston School of Public Health

References

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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.

Reference Type DERIVED
PMID: 20497785 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19953837 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18359949 (View on PubMed)

Other Identifiers

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R01HD037767

Identifier Type: NIH

Identifier Source: org_study_id

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