A School-Based Osteoporosis Prevention Program for Adolescent Girls

October 18, 2010 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

718

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Study Completion

June 1, 2002

Study Registration Dates

First Submitted

September 3, 2003

First Submitted That Met QC Criteria

September 3, 2003

First Posted (Estimate)

September 4, 2003

Study Record Updates

Last Update Posted (Estimate)

October 19, 2010

Last Update Submitted That Met QC Criteria

October 18, 2010

Last Verified

August 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01HD037767 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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