- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02855398
Decision-Making and the Relationship to Food Intake in Kids (DMK)
7 gennaio 2021 aggiornato da: Kathleen Loralee Keller, Penn State University
Understanding Decision-Making and the Relationship to Food Intake in Children 7 to 11 Years Old
The purpose of this 18-month project is to investigate how decision-making influences food choice and consumption in children ages 7 to 11 years old.
Although several studies suggest that the ability to make good decisions relates to eating behaviors, no studies have looked at how food reward influences the decision-making process to impact actual food intake.
This proposal will answer these questions and bridge this gap in knowledge, which could lead to the development of more effective interventions for childhood obesity.
To accomplish this, the investigators have assembled a diverse team with expertise in food intake, nutrition, and decision sciences.
First, the investigators will establish if there are differences in decision-making between children varying in weight status.
Second, the investigators will determine if performance on behavioral decision-making tasks relates to food consumption in the laboratory.
Third, the investigators will examine response functional magnetic resonance imaging (fMRI) blood-oxygen-level-dependent (BOLD) response to various rewards (i.e.
food and money) and determine if this is influenced by child weight status.
Fourth, the investigators will examine differences in fMRI BOLD at rest in decision-making regions are correlated with food intake and weight status.
Eighty-two children will participate in our study.
The long-term goal of this project is to investigate if there are differences in brain regions corresponding to these behaviors in overweight children and if these differences relate to eating behaviors in this population.
Children will undergo fMRI while playing a reward task as well as consume meals in our laboratory.
Decision-making will also be assessed by having children complete various behavioral measurements of reward and inhibitory control.
Panoramica dello studio
Stato
Completato
Condizioni
Tipo di studio
Osservativo
Iscrizione (Effettivo)
142
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Pennsylvania
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University Park, Pennsylvania, Stati Uniti, 16802
- The Pennsylvania State University
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 7 anni a 11 anni (Bambino)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
Children aged 7-11 years old.
Descrizione
Inclusion Criteria:
- Right-handed
- English as native language
- Reading at/above grade level
- Not Claustrophobic
- Generally Healthy
Exclusion Criteria:
- Left-handedness
- Metal in or on body that cannot be removed
- Claustrophobia
- Medication usage that may alter brain activity or blood flow
- Medical disorder that may impact comfort of safety in MRI scanner
- Food Allergies
- Dietary Restrictions
- Learning Disabilities
- Psychiatric Disorders
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response to various reward types (food, money, no reward).
Lasso di tempo: Collected at fMRI scan at week 4
|
Regions of interest BOLD analysis of an fMRI card-guessing task for various reward types
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Collected at fMRI scan at week 4
|
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Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response at rest (resting-state fMRI)
Lasso di tempo: Collected at fMRI scan at week 4
|
Regions of interest BOLD analysis of resting-state fMRI to examine differences in brain regions of interest at rest
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Collected at fMRI scan at week 4
|
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Behavioral inhibitory control task
Lasso di tempo: Collected at either week 1-3 (randomized)
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Measured by performance on a go/nogo task
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Collected at either week 1-3 (randomized)
|
|
Behavioral reward inhibitory control task
Lasso di tempo: Collected after the behavioral inhibitory control task (same visit), which is either week 1-3 (randomized)
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Measured by performance on a go/nogo task with a reward incentive
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Collected after the behavioral inhibitory control task (same visit), which is either week 1-3 (randomized)
|
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Behavioral risk-taking and reward task
Lasso di tempo: Collected at either week 1-3 (randomized)
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Measured by performance on the hungry donkey task
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Collected at either week 1-3 (randomized)
|
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Behavioral dietary self-control assessment
Lasso di tempo: Collected at either week 1-3 (randomized)
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Measured by performance on a dietary self-control task
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Collected at either week 1-3 (randomized)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Energy intake at baseline
Lasso di tempo: Collected at either week 1-3 (randomized)
|
Measured at an objective laboratory test-meal (kcal and grams)
|
Collected at either week 1-3 (randomized)
|
|
Energy intake at a buffet meal
Lasso di tempo: Collected at either week 1-3 (randomized)
|
Measured at an objective laboratory test-meal (kcal and grams)
|
Collected at either week 1-3 (randomized)
|
|
Energy intake after a meal preload
Lasso di tempo: Collected at either week 1-3 (randomized) following the baseline meal
|
Measured at an objective laboratory test-meal (kcal and grams)
|
Collected at either week 1-3 (randomized) following the baseline meal
|
|
Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response to various reward types (food, money, no reward).
Lasso di tempo: Collected at week 4
|
Whole brain BOLD analysis of an fMRI card-guessing task for various reward types
|
Collected at week 4
|
|
Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response at baseline
Lasso di tempo: Collected at week 4
|
Whole brain BOLD analysis of an fMRI card-guessing task for various reward types
|
Collected at week 4
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Altezza
Lasso di tempo: Raccolto alla settimana 1
|
Altezza in cm misurata allo stadiometro
|
Raccolto alla settimana 1
|
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Percentuale di grasso corporeo
Lasso di tempo: Raccolto alla settimana 1
|
Valutato mediante scala di analisi dell'impedenza bioelettrica
|
Raccolto alla settimana 1
|
|
Tratti appetitivi
Lasso di tempo: Raccolto alla settimana 1
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Questionario riferito dai genitori sugli stili alimentari abituali nei bambini
|
Raccolto alla settimana 1
|
|
Liking of foods
Lasso di tempo: Collected after each meal at multiple time points during weeks 1-4
|
Ratings of how much the child likes each food in the meal on a visual analog scale
|
Collected after each meal at multiple time points during weeks 1-4
|
|
Fullness feelings
Lasso di tempo: Collected at multiple time points during weeks 1-4
|
Ratings of how full the child feels measured on a child-friendly visual analog scale
|
Collected at multiple time points during weeks 1-4
|
|
Pubertal Development
Lasso di tempo: Collected at week 1
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Child report of pubertal status questionnaire
|
Collected at week 1
|
|
Weight
Lasso di tempo: Collected at week 1
|
Weight in kg measured by a standard digital scale
|
Collected at week 1
|
|
Body mass index
Lasso di tempo: Collected at week 1
|
Calculated from height, age, sex
|
Collected at week 1
|
|
BMI percentile
Lasso di tempo: Collected at week 1
|
Calculated from height, weight, age and sex - according to the Center for Disease Control (CDC) standards
|
Collected at week 1
|
|
BMI z-score
Lasso di tempo: Collected at week 1
|
Calculated from height, weight, age and sex - according to CDC standards
|
Collected at week 1
|
|
Fat mass index
Lasso di tempo: Collected at week 1
|
Calculated from height, weight, age, sex
|
Collected at week 1
|
|
Fat-free mass index
Lasso di tempo: Collected at week 1
|
Calculated from height, weight, age, sex
|
Collected at week 1
|
|
Parental feeding strategies
Lasso di tempo: Collected at week 1
|
Parent-reported questionnaire of feeding practices
|
Collected at week 1
|
|
Family demographics
Lasso di tempo: Collected at week 1
|
Parent-report questionnaire
|
Collected at week 1
|
|
Loss of control eating
Lasso di tempo: Collected at week 4
|
Loss of control when eating is frequently reported in middle childhood.
Loss of control when eating was assessed via interview-style questionnaire to determine pre-clinical binge-like eating behaviors that may influence the primary outcome of energy intake at the 4 conditions of test-meals.
|
Collected at week 4
|
|
Inhibitory control and reward sensitivity questionnaires
Lasso di tempo: Collected on either week 1-3 (randomized)
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Parent and child report of inhibitory control and reward sensitivity on a questionnaire
|
Collected on either week 1-3 (randomized)
|
|
Age
Lasso di tempo: Collected at the week 1
|
Age of participant
|
Collected at the week 1
|
|
Sex
Lasso di tempo: collected at week 1
|
sex of participant
|
collected at week 1
|
|
Parent height
Lasso di tempo: collected at week 1
|
height in cm of parent measured by a stadiometer
|
collected at week 1
|
|
Parent weight
Lasso di tempo: collected at week 1
|
weight in kg of parent measured by a standard digital scale
|
collected at week 1
|
|
parent body fat
Lasso di tempo: collected at week 1
|
measured by bioelectrical impedance
|
collected at week 1
|
|
Puberty Assessment Parental Report
Lasso di tempo: Collected at week 1
|
Parent report of pubertal status questionnaire
|
Collected at week 1
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Shana Adise, B.S., The Pennsylvania State University
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Adise S, White CN, Roberts NJ, Geier CF, Keller KL. Children's inhibitory control abilities in the presence of rewards are related to weight status and eating in the absence of hunger. Appetite. 2021 Dec 1;167:105610. doi: 10.1016/j.appet.2021.105610. Epub 2021 Jul 26.
- Adise S, Geier CF, Roberts NJ, White CN, Keller KL. Is brain response to food rewards related to overeating? A test of the reward surfeit model of overeating in children. Appetite. 2018 Sep 1;128:167-179. doi: 10.1016/j.appet.2018.06.014. Epub 2018 Jun 8.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 aprile 2015
Completamento primario (Effettivo)
1 ottobre 2016
Completamento dello studio (Effettivo)
1 dicembre 2017
Date di iscrizione allo studio
Primo inviato
29 giugno 2016
Primo inviato che soddisfa i criteri di controllo qualità
3 agosto 2016
Primo Inserito (Stima)
4 agosto 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
11 gennaio 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
7 gennaio 2021
Ultimo verificato
1 gennaio 2021
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- DecisionMakingEatingKids01
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .