- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00067925
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding
Fase
- Fase 1
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Deanna M Hoelscher, PhD, University of Texas-Houston School of Public Health
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01HD037767 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .