search
Back to results

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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

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

10 Years - 13 Years (Child)FemaleAccepts Healthy Volunteers

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

    First Posted
    September 3, 2003
    Last Updated
    October 18, 2010
    Sponsor
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    search

    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

    Learn more about this trial

    A School-Based Osteoporosis Prevention Program for Adolescent Girls

    We'll reach out to this number within 24 hrs