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Evaluating a Mindful Eating Curriculum, "Savor the Flavor"

5. juni 2020 oppdatert av: Jennifer Savage Williams, Penn State University

Evaluating a Mindful Eating Curriculum, "Savor the Flavor" to Promote Healthy Eating Among Head Start Preschool Children

The overall goal of this study is to conduct a preliminary evaluation of the feasibility and efficacy of the "Savor the Flavor" intervention.

Studieoversikt

Status

Fullført

Forhold

Spiseatferd

Intervensjon / Behandling

Atferdsmessig: Savor the Flavor

Detaljert beskrivelse

The overall goal of this study is to conduct a preliminary evaluation of the feasibility and efficacy of the "Savor the Flavor" intervention. The goal of this curriculum is to teach children how to savor foods and slow down while eating by focusing on the sensory experience of eating. The intervention will also teach children attention control techniques so that they are better able to delay consumption of high energy, low nutrition foods, when appropriate.The study will also evaluate a modified version of the Eating in the Absence of Hunger task for use in a preschool classroom setting.

Studietype

Intervensjonell

Registrering (Faktiske)

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
- Pennsylvania
  - University Park, Pennsylvania, Forente stater, 16802
    - Pennsylvania 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

2 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Child Inclusion Criteria:

Child must be enrolled in a Head Start preschool center
Child must be between the ages of 2 and 6 years old

Child Exclusion Criteria:

Food allergy or restriction to foods included in protocol

Parent Inclusion Criteria:

Parent or other primary caregiver of a child enrolled in the study
18 years of age or older
English speaking

Parent Exclusion Criteria:

- None

Teacher Inclusion Criteria:

Actively employed as an early childhood education provider in the Head Start classroom where intervention is delivered
18 years of age or older

Teacher Exclusion Criteria:

- None

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: N/A
Intervensjonsmodell: Enkeltgruppeoppdrag
Masking: Ingen (Open Label)

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm	Intervensjon / Behandling
Eksperimentell: Savor the Flavor The "Savor the Flavor" curriculum is a series of five interactive lessons designed to teach children how to savor foods and slow down while eating by focusing on the sensory experience of eating. The intervention also teaches attention control techniques so that children are better able to delay consumption of high energy, low nutrition foods, when appropriate, as well as general mindfulness practices (e.g. breathing exercises). Lessons are delivered in the Head Start classroom by a nutrition educator.	Atferdsmessig: Savor the Flavor A series of five interactive classroom lessons focused on mindfulness in eating.

Deltakergruppe / Arm

Intervensjon / Behandling

Eksperimentell: Savor the Flavor

The "Savor the Flavor" curriculum is a series of five interactive lessons designed to teach children how to savor foods and slow down while eating by focusing on the sensory experience of eating. The intervention also teaches attention control techniques so that children are better able to delay consumption of high energy, low nutrition foods, when appropriate, as well as general mindfulness practices (e.g. breathing exercises). Lessons are delivered in the Head Start classroom by a nutrition educator.

Atferdsmessig: Savor the Flavor

A series of five interactive classroom lessons focused on mindfulness in eating.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Change in eating in the absence of hunger from pre to post intervention Tidsramme: Pre intervention and at conclusion of 5 week intervention	Children will be given seven minutes of free access to a variety of palatable snacks and toys during a time when they are not hungry (e.g. after a meal). Intake of snacks is determined by pre and post weighing the foods.	Pre intervention and at conclusion of 5 week intervention

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Recall of Savor the Flavor steps Tidsramme: At conclusion of 5 week intervention	Children will be asked to recall the five steps of "Savor the Flavor"	At conclusion of 5 week intervention
Acceptability of intervention Tidsramme: At conclusion of 5 week intervention	Teachers will complete a questionnaire with scaled and open-ended questions about the feasibility and acceptability of the intervention	At conclusion of 5 week intervention

Andre resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Child body mass index Tidsramme: Measured once at any time between enrollment and conclusion of 5 week intervention	Child height and weight will be measured and used to calculate body mass index (BMI). Age and sex specific BMI percentiles/z-scores will be calculated using CDC growth standards	Measured once at any time between enrollment and conclusion of 5 week intervention
Child Eating Behavior Questionnaire Tidsramme: Measured once at any time between enrollment and conclusion of 5 week intervention	Parents will complete the Child Eating Behavior Questionnaire as part of a survey packet	Measured once at any time between enrollment and conclusion of 5 week intervention
Structure and Control in Parent Feeding Tidsramme: Measured once at any time between enrollment and conclusion of 5 week intervention	Parents will complete the Structure and Control in Parent Feeding as part of a survey packet	Measured once at any time between enrollment and conclusion of 5 week intervention
USDA Food Security questionnaire Tidsramme: Measured once at any time between enrollment and conclusion of 5 week intervention	Parents will complete the USDA food security questionnaire as part of a survey packet	Measured once at any time between enrollment and conclusion of 5 week intervention
External Food Responsiveness scale Tidsramme: Measured once at any time between enrollment and conclusion of 5 week intervention	Parents will complete the External Food Responsiveness Scale as part of a survey packet	Measured once at any time between enrollment and conclusion of 5 week intervention
Eating in the Absence of Hunger scale Tidsramme: Measured once at any time between enrollment and conclusion of 5 week intervention	Parents will complete the Eating in the Absence of Hunger Scale as part of a survey packet	Measured once at any time between enrollment and conclusion of 5 week intervention

Samarbeidspartnere og etterforskere

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

Sponsor

Penn State University

Etterforskere

Hovedetterforsker: Jennifer S Savage, PhD, Penn State University

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)

1. oktober 2019

Primær fullføring (Faktiske)

31. desember 2019

Studiet fullført (Faktiske)

31. desember 2019

Datoer for studieregistrering

Først innsendt

9. oktober 2019

Først innsendt som oppfylte QC-kriteriene

14. oktober 2019

Først lagt ut (Faktiske)

16. oktober 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. juni 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. juni 2020

Sist bekreftet

1. juni 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

STUDY00013064

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

IPD-planbeskrivelse

De-identified individual participant data will be available from the principal investigator upon request.

IPD-delingstidsramme

Data will be available after publication of primary outcomes.

Tilgangskriterier for IPD-deling

Access requests will be evaluated and approved at the principal investigator's discretion.

IPD-deling Støtteinformasjonstype

STUDY_PROTOCOL
SEVJE
ICF
ANALYTIC_CODE
CSR

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. .

Evaluating a Mindful Eating Curriculum, "Savor the Flavor"