- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03752008
Preschoolers Active at Child Care (PACT) (PACT)
21. november 2018 oppdatert av: Pooja Tandon, Seattle Children's Hospital
Preschoolers Active at Child Care
The aim of this study was to develop, test, and compare two approaches to increasing physical activity (PA) and decreasing sedentary time among young children at child care centers, one which focused on a teacher-led PA curriculum (AP=Active Play!) and the other on increasing outdoor free play time (OP=Outdoor Play!).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This was a matched pair cluster-randomized study in 10 child care centers.
One classroom in each pair received either AP or OP, and their providers received a condition-specific 3-hour workshop.
Pre- and post-intervention data were collected from classroom observation and accelerometers.
Additional information about teachers' attitudes and practices was collected via pre-intervention survey.
Studietype
Intervensjonell
Registrering (Faktiske)
131
Fase
- Ikke aktuelt
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
3 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Teachers/Staff
- be a teacher/staff member in a participating childcare center
- Students
- be 3 - 5 years old
- be a full day student in the classroom where data collection was occurring
Exclusion Criteria:
-
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Active Play (AP)
This arm received the Active Play curriculum intervention (described in following section).
|
This intervention focused on promoting PA in preschoolers through structured, teacher-led activities that could be incorporated into daily curriculum.
Teachers attended a 3-hour workshop that included presentation and discussion of 1) the importance of daily physical activity for children's health and development, 2) teachers' beliefs and barriers to promoting PA, and 3) the Active Play! Intervention materials.
Teachers were introduced to and given the Active Play! Fun Physical Activities for Young Children Book and Digital Video Disk (DVD), which promotes PA and fundamental movement skills in young children.
Clips of the DVD demonstrating various activities were shown and activities were modeled.
Examples of activities include jumping on bubble wrap, hula hoop limbo and an indoor obstacle course.
The end of the book has a suggested curriculum that teachers could follow.
Centers in the Active Play! intervention also received a set of portable toys needed for the suggested activities.
|
|
Eksperimentell: Outdoor Play (OP)
This arm received the Outdoor Play curriculum intervention (described in following section).
|
This intervention focused on promoting outdoor time in preschoolers as a means to increasing their PA, using both child initiated and teacher-led activities.
The training and materials were designed to emphasize the teacher's own connection with nature, the benefits of outdoor time for children and adults, and problem solving around barriers encountered.
Teachers at participating centers attended one 3-hour workshop (delivered at the childcare center) that focused on having participants recognize their own connection with the natural world and how to transmit that to the next generation.
Teachers were given hats and gloves for themselves, a set of rain jackets and boots for the preschoolers, and ideas on what children could do outdoors to be active.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pre to post change in preschoolers Physical Activity
Tidsramme: baseline and 12 weeks after intervention
|
Physical Activity levels measured by actigraphy monitors
|
baseline and 12 weeks after intervention
|
|
Pre to post change in Physical Activity Opportunities
Tidsramme: baseline and 12 weeks after intervention
|
Minutes where students could be physically active by observation (RA observed and wrote down times for when children were engaged in various activities and categorized them as active play opportunities or non active play opportunities.
Total minutes in each category were calculated.
|
baseline and 12 weeks after intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
pre to post Teacher Physical Activity
Tidsramme: baseline and 12 weeks after intervention
|
Physical Activity levels measured by actigraphy monitors
|
baseline and 12 weeks after intervention
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Pooja Tandon, MD MPH, Seattle Chidlren's
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 (Faktiske)
4. desember 2012
Primær fullføring (Faktiske)
24. april 2014
Studiet fullført (Faktiske)
24. april 2014
Datoer for studieregistrering
Først innsendt
20. november 2018
Først innsendt som oppfylte QC-kriteriene
21. november 2018
Først lagt ut (Faktiske)
23. november 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. november 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. november 2018
Sist bekreftet
1. november 2018
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 14169 (Annen identifikator: City of Hope Medical Center)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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