- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04127812
Evaluating a Mindful Eating Curriculum, "Savor the Flavor"
5. juni 2020 opdateret af: 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.
Studieoversigt
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
49
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Pennsylvania
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University Park, Pennsylvania, Forenede Stater, 16802
- Pennsylvania State University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
2 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
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A series of five interactive classroom lessons focused on mindfulness in eating.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in eating in the absence of hunger from pre to post intervention
Tidsramme: Pre intervention and at conclusion of 5 week intervention
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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.
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Pre intervention and at conclusion of 5 week intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Recall of Savor the Flavor steps
Tidsramme: At conclusion of 5 week intervention
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Children will be asked to recall the five steps of "Savor the Flavor"
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At conclusion of 5 week intervention
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Acceptability of intervention
Tidsramme: At conclusion of 5 week intervention
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Teachers will complete a questionnaire with scaled and open-ended questions about the feasibility and acceptability of the intervention
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At conclusion of 5 week intervention
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Child body mass index
Tidsramme: Measured once at any time between enrollment and conclusion of 5 week intervention
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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
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Measured once at any time between enrollment and conclusion of 5 week intervention
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Child Eating Behavior Questionnaire
Tidsramme: Measured once at any time between enrollment and conclusion of 5 week intervention
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Parents will complete the Child Eating Behavior Questionnaire as part of a survey packet
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Measured once at any time between enrollment and conclusion of 5 week intervention
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Structure and Control in Parent Feeding
Tidsramme: Measured once at any time between enrollment and conclusion of 5 week intervention
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Parents will complete the Structure and Control in Parent Feeding as part of a survey packet
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Measured once at any time between enrollment and conclusion of 5 week intervention
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USDA Food Security questionnaire
Tidsramme: Measured once at any time between enrollment and conclusion of 5 week intervention
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Parents will complete the USDA food security questionnaire as part of a survey packet
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Measured once at any time between enrollment and conclusion of 5 week intervention
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External Food Responsiveness scale
Tidsramme: Measured once at any time between enrollment and conclusion of 5 week intervention
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Parents will complete the External Food Responsiveness Scale as part of a survey packet
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Measured once at any time between enrollment and conclusion of 5 week intervention
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Eating in the Absence of Hunger scale
Tidsramme: Measured once at any time between enrollment and conclusion of 5 week intervention
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Parents will complete the Eating in the Absence of Hunger Scale as part of a survey packet
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Measured once at any time between enrollment and conclusion of 5 week intervention
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jennifer S Savage, PhD, Penn State University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. oktober 2019
Primær færdiggørelse (Faktiske)
31. december 2019
Studieafslutning (Faktiske)
31. december 2019
Datoer for studieregistrering
Først indsendt
9. oktober 2019
Først indsendt, der opfyldte QC-kriterier
14. oktober 2019
Først opslået (Faktiske)
16. oktober 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. juni 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. juni 2020
Sidst verificeret
1. juni 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- STUDY00013064
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
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.
IPD-delingsadgangskriterier
Access requests will be evaluated and approved at the principal investigator's discretion.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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