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- Klinische proef NCT02855398
Decision-Making and the Relationship to Food Intake in Kids (DMK)
7 januari 2021 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Studietype
Observationeel
Inschrijving (Werkelijk)
142
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Pennsylvania
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University Park, Pennsylvania, Verenigde Staten, 16802
- The Pennsylvania State University
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
7 jaar tot 11 jaar (Kind)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
Children aged 7-11 years old.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response to various reward types (food, money, no reward).
Tijdsspanne: 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)
Tijdsspanne: Collected at fMRI scan at week 4
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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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Energy intake at baseline
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
|
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).
Tijdsspanne: 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
Tijdsspanne: Collected at week 4
|
Whole brain BOLD analysis of an fMRI card-guessing task for various reward types
|
Collected at week 4
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Hoogte
Tijdsspanne: Verzameld in week 1
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Hoogte in cm gemeten door stadiometer
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Verzameld in week 1
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Lichaamsvet percentage
Tijdsspanne: Verzameld in week 1
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Beoordeeld door bio-elektrische impedantieanalyseschaal
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Verzameld in week 1
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Appetijtelijke eigenschappen
Tijdsspanne: Verzameld in week 1
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Door ouders gerapporteerde vragenlijst over gebruikelijke eetstijlen bij kinderen
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Verzameld in week 1
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Liking of foods
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Collected at week 1
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Calculated from height, age, sex
|
Collected at week 1
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BMI percentile
Tijdsspanne: 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
Tijdsspanne: Collected at week 1
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Calculated from height, weight, age and sex - according to CDC standards
|
Collected at week 1
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Fat mass index
Tijdsspanne: Collected at week 1
|
Calculated from height, weight, age, sex
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Collected at week 1
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Fat-free mass index
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Collected at week 1
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Parent-report questionnaire
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Collected at week 1
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Loss of control eating
Tijdsspanne: Collected at week 4
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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
Tijdsspanne: 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
Tijdsspanne: Collected at the week 1
|
Age of participant
|
Collected at the week 1
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Sex
Tijdsspanne: collected at week 1
|
sex of participant
|
collected at week 1
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Parent height
Tijdsspanne: collected at week 1
|
height in cm of parent measured by a stadiometer
|
collected at week 1
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Parent weight
Tijdsspanne: collected at week 1
|
weight in kg of parent measured by a standard digital scale
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collected at week 1
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parent body fat
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Shana Adise, B.S., The Pennsylvania State University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 april 2015
Primaire voltooiing (Werkelijk)
1 oktober 2016
Studie voltooiing (Werkelijk)
1 december 2017
Studieregistratiedata
Eerst ingediend
29 juni 2016
Eerst ingediend dat voldeed aan de QC-criteria
3 augustus 2016
Eerst geplaatst (Schatting)
4 augustus 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
11 januari 2021
Laatste update ingediend die voldeed aan QC-criteria
7 januari 2021
Laatst geverifieerd
1 januari 2021
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- DecisionMakingEatingKids01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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