- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02855398
Decision-Making and the Relationship to Food Intake in Kids (DMK)
7 janvier 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Observationnel
Inscription (Réel)
142
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Pennsylvania
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University Park, Pennsylvania, États-Unis, 16802
- The Pennsylvania State University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
7 ans à 11 ans (Enfant)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
Children aged 7-11 years old.
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response to various reward types (food, money, no reward).
Délai: Collected at fMRI scan at week 4
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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)
Délai: 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
Délai: 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)
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Behavioral reward inhibitory control task
Délai: 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
Délai: 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
Délai: 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)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Energy intake at baseline
Délai: Collected at either week 1-3 (randomized)
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Measured at an objective laboratory test-meal (kcal and grams)
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Collected at either week 1-3 (randomized)
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Energy intake at a buffet meal
Délai: 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
Délai: Collected at either week 1-3 (randomized) following the baseline meal
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Measured at an objective laboratory test-meal (kcal and grams)
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Collected at either week 1-3 (randomized) following the baseline meal
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Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response to various reward types (food, money, no reward).
Délai: 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
Délai: Collected at week 4
|
Whole brain BOLD analysis of an fMRI card-guessing task for various reward types
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Collected at week 4
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hauteur
Délai: Collecté à la semaine 1
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Taille en cm mesurée au stadiomètre
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Collecté à la semaine 1
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Pourcentage de graisse corporelle
Délai: Collecté à la semaine 1
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Évalué par une échelle d'analyse d'impédance bioélectrique
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Collecté à la semaine 1
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Traits d'appétit
Délai: Collecté à la semaine 1
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Questionnaire déclaré par les parents sur les habitudes alimentaires des enfants
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Collecté à la semaine 1
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Liking of foods
Délai: Collected after each meal at multiple time points during weeks 1-4
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Ratings of how much the child likes each food in the meal on a visual analog scale
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Collected after each meal at multiple time points during weeks 1-4
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Fullness feelings
Délai: Collected at multiple time points during weeks 1-4
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Ratings of how full the child feels measured on a child-friendly visual analog scale
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Collected at multiple time points during weeks 1-4
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Pubertal Development
Délai: Collected at week 1
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Child report of pubertal status questionnaire
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Collected at week 1
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Weight
Délai: Collected at week 1
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Weight in kg measured by a standard digital scale
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Collected at week 1
|
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Body mass index
Délai: Collected at week 1
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Calculated from height, age, sex
|
Collected at week 1
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BMI percentile
Délai: Collected at week 1
|
Calculated from height, weight, age and sex - according to the Center for Disease Control (CDC) standards
|
Collected at week 1
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BMI z-score
Délai: Collected at week 1
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Calculated from height, weight, age and sex - according to CDC standards
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Collected at week 1
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Fat mass index
Délai: Collected at week 1
|
Calculated from height, weight, age, sex
|
Collected at week 1
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Fat-free mass index
Délai: Collected at week 1
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Calculated from height, weight, age, sex
|
Collected at week 1
|
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Parental feeding strategies
Délai: Collected at week 1
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Parent-reported questionnaire of feeding practices
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Collected at week 1
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Family demographics
Délai: Collected at week 1
|
Parent-report questionnaire
|
Collected at week 1
|
|
Loss of control eating
Délai: 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.
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Collected at week 4
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Inhibitory control and reward sensitivity questionnaires
Délai: Collected on either week 1-3 (randomized)
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Parent and child report of inhibitory control and reward sensitivity on a questionnaire
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Collected on either week 1-3 (randomized)
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Age
Délai: Collected at the week 1
|
Age of participant
|
Collected at the week 1
|
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Sex
Délai: collected at week 1
|
sex of participant
|
collected at week 1
|
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Parent height
Délai: collected at week 1
|
height in cm of parent measured by a stadiometer
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collected at week 1
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Parent weight
Délai: collected at week 1
|
weight in kg of parent measured by a standard digital scale
|
collected at week 1
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parent body fat
Délai: collected at week 1
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measured by bioelectrical impedance
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collected at week 1
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Puberty Assessment Parental Report
Délai: Collected at week 1
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Parent report of pubertal status questionnaire
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Collected at week 1
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Shana Adise, B.S., The Pennsylvania State University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 avril 2015
Achèvement primaire (Réel)
1 octobre 2016
Achèvement de l'étude (Réel)
1 décembre 2017
Dates d'inscription aux études
Première soumission
29 juin 2016
Première soumission répondant aux critères de contrôle qualité
3 août 2016
Première publication (Estimation)
4 août 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 janvier 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 janvier 2021
Dernière vérification
1 janvier 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- DecisionMakingEatingKids01
Plan pour les données individuelles des participants (IPD)
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