EXCEL: Change in Cardiometabolic Disease Risk Factors During an Interactive Fitness Program (EXCEL)
22. mai 2014 oppdatert av: Laura Hayman, University of Massachusetts, Boston
Childhood obesity has increased in prevalence over the past several decades and is predictive of adult type 2 diabetes and cardiovascular disease (CVD).
Recent studies of children and youth suggest that exercise reduces cardiometabolic risk factors.
Minimal data are available, however, on the effects of "exergaming" , interactive technology- mediated approaches to increasing physical activity in children and youth.
This project involves a partnership between UMass Boston/GoKids Boston and Children's Hospital Boston featuring an interdisciplinary team of researchers and clinicians from pediatric cardiology, nursing, prevention and behavioral sciences and exercise physiology and is designed to examine the effects of exergaming on moderate or vigorous physical activity (MVPA) indices of adiposity, risk factors for cardiometabolic disease and self-competence in Boston Public School children.
It is hypothesized that participation in the EXCEL/exergaming intervention for 60 minutes, three times per week for 12 weeks will significantly increase MVPA (as measured by accelerometers), pre- to- post intervention and compared to an Advice only (Nutrition Education) group.Results of this pilot study will guide and inform a larger study of exergaming in children from the Boston Public Schools.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
60
Fase
- Fase 1
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
8 år til 12 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- enrolled in grades 3-5
- able to attend GoKids and school-based weekly educational sessions for 12 weeks and complete baseline and follow-up testing
- informed consent from a parent or legal guardian and written assent from the child
- English speaking child
- free from medical conditions that would prohibit exercise as indicated by permission to participate in school physical education, and by review of screening questions with clearance from primary care provider as necessary.
Exclusion Criteria:
- abnormalities on screening/baseline evaluation that could pose a significant risk for exercise
- illness that would limit participation
- plans to move out of the area or change schools in the next 6 months
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Nutrition Education/Lifestyle Counseling
Children in this group will receive weekly group nutrition sessions , 30 minutes per week for 12 weeks, identical to those provided for the EXCEL intervention group and delivered by a registered dietician.
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Children in the nutrition education group will receive 30 minutes per week of group nutrition education in the school environment and delivered by a registered dietitian The nutrition education sessions will be identical to those provided for the EXCEL group.
|
|
Eksperimentell: EXCEL
The EXCEL arm is the experimental arm of the study.
Participants in this arm will receive supervised physical activity in the form of novel gaming (technology-mediated physical activity, 60 minutes per session, three times per week , for 12 weeks and 12 weeks of group nutrition education sessions.
|
Children in the EXCEL intervention will receive 12 weeks of supervised physical activity, guided by principles of behavior change, in the form of exergaming (technology-mediated interactive physical activity)3 times per week for 12 weeks and will also receive weekly group nutrition education sessions
Participants in the EXCEL intervention will receive 12 weeks of supervised physical activity in the form of exergaming (technology-mediated physical activity).
Sessions will be held 3 times per week with 60 minutes of supervised physical activity.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
change in moderate or vigorous physical activity (MVPA) between baseline and final visit (12 weeks) in children in the Excel intervention group as compared to children in the Advice only (Nutrition Education) group.
Tidsramme: 12 weeks; follow up at 18 weeks
|
The primary test of hypothesis is the comparison of change in MVPA between baseline and final visit (12 weeks) in children in the Excel intervention group as compared to children in the Advice-only (Nutrition Education) group.
Accelerometers will be used to measure MVPA.
|
12 weeks; follow up at 18 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
pre-post EXCEL intervention changes in cardiorespiratory fitness and cardiometabolic risk factors (blood lipids, blood pressure, body mass index [BMI], waist circumference)
Tidsramme: 12 weeks; follow-up at 18 weeks
|
Cardiorespiratory fitness and cardiometabolic risk factors will be assessed at baseline and 12 and 18 weeks post-intervention in EXCEL intervention group and in the Advice only (Nutrition Education) group.
Between and within group changes in cardiorespiratory fitness and cardiometabolic risk factors will be examined and compared at the 12 week and 18 week data point.
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12 weeks; follow-up at 18 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2010
Primær fullføring (Faktiske)
1. juni 2013
Studiet fullført (Faktiske)
1. juli 2013
Datoer for studieregistrering
Først innsendt
13. april 2010
Først innsendt som oppfylte QC-kriteriene
14. april 2010
Først lagt ut (Anslag)
15. april 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
26. mai 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. mai 2014
Sist bekreftet
1. mai 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UMBCHB007
- UL1RR025758-02 (U.S. NIH-stipend/kontrakt)
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