- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT06108128
Stof tot nadenken: uitvoerend functioneren rond eten onder kinderen
Karakterisering van de top-down dimensies van zelfregulering van de eetlust bij kleuters
Scientific knowledge of the cognitive-developmental processes that serve to support children's appetite self-regulation are surprisingly limited. This investigation will provide new scientific directions for obesity prevention by elucidating cognitive-developmental influences on young children's ability to make healthy food choices and eat in moderation.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Appetite self-regulation (ASR) has been described as involving children's use of eating-specific, "top-down" cognitive processes to moderate "bottom-up" biological drives to eat. Much of the research to date on ASR has focused on the role of bottom-up drives in shaping children's behavioral susceptibility to obesity. Alternatively, little is known about the cognitive-developmental processes that shape children's ability to make healthy food choices and eat in moderation during early childhood. The goal of this exploratory investigation is to produce rigorous evidence of cognitive developmental influences on healthy eating behaviors and weight status during preschool through the development of new measures of top-down ASR. Participants will be 125 preschoolers and their primary caregiver. Existing measures of executive functioning in children will be adapted to create new measures of eating-specific, top-down ASR. Associations with children's eating behaviors, body mass index z-scores, food parenting will be assessed.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19140
- Temple University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Child ages 4 to 6 years of age
- Caregiver reporting primary responsibility for child feeding outside of childcare
- Caregiver legal guardian
Exclusion Criteria:
- Caregiver <18 years of age
- Child major food allergies
- Child medication use, developmental disability, or medical conditions known to affect food intake and/or growth; color blindness
- Child in foster care
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Ander: Caregiver-child dyads
Observational study of executive functioning around eating and parenting |
Interventions take place solely at the measurement level, where children will be seen in observational tasks of general executive functioning and executive functioning around eating in which various food and non-food stimuli are presented and children's responses to task instructions are recorded. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Food choice
Tijdsspanne: Assessed at 1 of 2 study visits over 2 weeks
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Children's forced-choice selection of fruits, vegetables, and water over alternatives at a meal |
Assessed at 1 of 2 study visits over 2 weeks
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Eating in the absence of hunger
Tijdsspanne: Assessed at 1 of 2 study visits over 2 weeks
|
Children's intake of palatable foods following a standard meal |
Assessed at 1 of 2 study visits over 2 weeks
|
|
Body mass index z-score
Tijdsspanne: Assessed at 1 of 2 study visits over 2 weeks
|
Age and sex specific z-score using CDC reference data |
Assessed at 1 of 2 study visits over 2 weeks
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Jennifer O Fisher, PHD, Temple University
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- R21HD109362 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Research data generated by the project will be supported by TUScholarShare (https://scholarshare.temple.edu/), the institutional repository for Temple University. This is a repository service that is managed by the Temple University Libraries and uses Open Repository, an enhanced DSpace platform that is hosted by Atmire. TUScholarShare has been developed with the intent of helping researchers comply with grant-funding agency requirements. It enables dissemination and long-term preservation and curation (management, use, and re-use) of data.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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