- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02855398
Decision-Making and the Relationship to Food Intake in Kids (DMK)
7. Januar 2021 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
142
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Pennsylvania
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University Park, Pennsylvania, Vereinigte Staaten, 16802
- The Pennsylvania State University
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
7 Jahre bis 11 Jahre (Kind)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Wahrscheinlichkeitsstichprobe
Studienpopulation
Children aged 7-11 years old.
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response to various reward types (food, money, no reward).
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Energy intake at baseline
Zeitfenster: 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)
|
|
Energy intake at a buffet meal
Zeitfenster: 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
Zeitfenster: 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).
Zeitfenster: Collected at week 4
|
Whole brain BOLD analysis of an fMRI card-guessing task for various reward types
|
Collected at week 4
|
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Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response at baseline
Zeitfenster: 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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Höhe
Zeitfenster: Gesammelt in Woche 1
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Körpergröße in cm gemessen mit Stadiometer
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Gesammelt in Woche 1
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Körperfettanteil
Zeitfenster: Gesammelt in Woche 1
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Bewertet durch die Analyseskala der bioelektrischen Impedanz
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Gesammelt in Woche 1
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Appetitliche Eigenschaften
Zeitfenster: Gesammelt in Woche 1
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Von Eltern gemeldeter Fragebogen zu gewohnheitsmäßigen Essgewohnheiten bei Kindern
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Gesammelt in Woche 1
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|
Liking of foods
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Collected at week 1
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Weight in kg measured by a standard digital scale
|
Collected at week 1
|
|
Body mass index
Zeitfenster: Collected at week 1
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Calculated from height, age, sex
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Collected at week 1
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BMI percentile
Zeitfenster: Collected at week 1
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Calculated from height, weight, age and sex - according to the Center for Disease Control (CDC) standards
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Collected at week 1
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BMI z-score
Zeitfenster: 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
Zeitfenster: Collected at week 1
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Calculated from height, weight, age, sex
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Collected at week 1
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Fat-free mass index
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Collected at week 1
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Parent-report questionnaire
|
Collected at week 1
|
|
Loss of control eating
Zeitfenster: 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
Zeitfenster: 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)
|
|
Age
Zeitfenster: Collected at the week 1
|
Age of participant
|
Collected at the week 1
|
|
Sex
Zeitfenster: collected at week 1
|
sex of participant
|
collected at week 1
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|
Parent height
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Collected at week 1
|
Parent report of pubertal status questionnaire
|
Collected at week 1
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Shana Adise, B.S., The Pennsylvania State University
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. April 2015
Primärer Abschluss (Tatsächlich)
1. Oktober 2016
Studienabschluss (Tatsächlich)
1. Dezember 2017
Studienanmeldedaten
Zuerst eingereicht
29. Juni 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
3. August 2016
Zuerst gepostet (Schätzen)
4. August 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
11. Januar 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
7. Januar 2021
Zuletzt verifiziert
1. Januar 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- DecisionMakingEatingKids01
Plan für individuelle Teilnehmerdaten (IPD)
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NEIN
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