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Sustainability Via Active Garden Education (SAGE)

3. desember 2020 oppdatert av: Arizona State University

Partnering for PA in Early Childhood: Sustainability Via Active Garden Education

The goal of SAGE is to determine if a garden-based curriculum can increase physical activity and improve nutrition in young children at early care and education centers (ECEC) throughout Phoenix

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

SAGE will be delivered over a four month period using a cluster randomized controlled trial adapted crossover design, along with testing a sustainability action plan (SAP) at the organizational level. In this study, the investigators will determine the efficacy of the SAGE intervention on health in 3-4 year-old children. This study will pair match and randomize 20 ECEC from neighborhoods with high proportions of Hispanic or Latino residents. ECEC will receive either the SAGE intervention or the safety attention comparison. Then, ECEC will cross over and receive the treatment that they did not receive to ensure that all ECEC receive both curricula. The investigators will determine improvement in accelerometry measured PA and sedentary behaviors, fruit and vegetable consumption and explore eating in the absence of hunger compared to those in a child safety attention comparison. The investigators will explore secondary impacts on parenting practices that promote PA and fruit and vegetable consumption, home fruit and vegetable availability and improved household food security. This study will explore the process of delivery of the SAGE intervention on dimensions of reach, adoption, and implementation. This study will also develop, implement, and evaluate a SAP in the SAGE arm to determine replicability and institutionalization (sustainability) of the SAGE intervention and explore the relationship between of sustainability to child outcomes at follow-up. The development and success of the community Partnership and SAGE Community Advisory Board will also be evaluated using indicators of participation, representativeness, and collaboration. This study will rely on CBPR strategies and an established theoretical model to implement an engaging and translational multilevel intervention linking policy and practice. This work will test strategies for implementing IOM guidelines at the ECE level and will guide future efforts aimed at scaling up efficacious interventions for broad dissemination in vulnerable populations to reduce health disparities.

Studietype

Intervensjonell

Registrering (Forventet)

1275

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater, 85004
        • Arizona State University

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 til 65 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

ECEC Inclusion Criteria:

  • Census tracts with >30% Hispanic-Latino population
  • ECEC must be licensed and enroll at least 35 children aged 3-4 years old
  • Space for garden install

Exclusion Criteria:

  • Not participating in CACFP
  • No space for a garden
  • Less than 35 children aged 3-5 years old enrolled

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: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Physical Activity
SAGE curriculum is a garden-based PA and nutrition educational program and presently includes 12 lessons that can be delivered once or twice a week. The SAGE garden-based curriculum includes active games and discussion as well as activities that include watering the ECEC garden.
Atferdsmessig: Physical Activity
SAGE curriculum is a garden-based PA and nutrition educational program for early care and education centers.
Andre navn:
  • SAGE Garden Based Curriculum
Aktiv komparator: Child Safety Attention Comparison
The goal of this comparison group is to provide centers with an engaging, useful, carefully sequenced, and easy-to-deliver curriculum so that randomization to this group does not influence attrition or reach and serves as a placebo (unlikely to affect outcomes of interest. The curriculum will include concepts and lessons for educating young children on fire, pedestrian, water, household, neighborhood and playground safety. The curriculum includes handouts, coloring sheets, comic books, games, and songs that can be implemented with minimal training and preparation.
Atferdsmessig: Child Safety Attention Comparison
The goal of this comparison group is to provide centers with an engaging, useful, carefully sequenced, and easy-to-deliver curriculum so that randomization to this group does not influence attrition or reach and serves as a placebo (unlikely to affect outcomes of interest).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change physical activity; sedentary time
Tidsramme: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
Assessed by ActiGraph accelerometers
Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
fruit and vegetable consumption
Tidsramme: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
24 hr diet recalls
Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Impact on parenting practices in physical activity (PA)
Tidsramme: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
Assessed by physical activity
Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
Impact on improved home fruit and vegetable availability
Tidsramme: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
Assessed by completing Home Food Inventory questionnaire
Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
Impact on parenting practices in fruits and vegetables
Tidsramme: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
Assessed by fruit and vegetable pactices questionnaire
Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Arizona State University

Samarbeidspartnere

National Institute on Minority Health and Health Disparities (NIMHD)

Etterforskere

  • Hovedetterforsker: Rebecca E Lee, PhD, Arizona State University

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.

Generelle publikasjoner

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)

30. januar 2017

Primær fullføring (Forventet)

31. desember 2020

Studiet fullført (Forventet)

31. desember 2020

Datoer for studieregistrering

Først innsendt

13. april 2017

Først innsendt som oppfylte QC-kriteriene

22. august 2017

Først lagt ut (Faktiske)

25. august 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. desember 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. desember 2020

Sist bekreftet

1. desember 2020

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 5U01MD010667 (U.S. NIH-stipend/kontrakt)

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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