- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02855398
Decision-Making and the Relationship to Food Intake in Kids (DMK)
7. januar 2021 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
142
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Pennsylvania
-
University Park, Pennsylvania, Forenede Stater, 16802
- The Pennsylvania State University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
7 år til 11 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Children aged 7-11 years old.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response to various reward types (food, money, no reward).
Tidsramme: Collected at fMRI scan at week 4
|
Regions of interest BOLD analysis of an fMRI card-guessing task for various reward types
|
Collected at fMRI scan at week 4
|
Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response at rest (resting-state fMRI)
Tidsramme: 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
|
Collected at fMRI scan at week 4
|
Behavioral inhibitory control task
Tidsramme: Collected at either week 1-3 (randomized)
|
Measured by performance on a go/nogo task
|
Collected at either week 1-3 (randomized)
|
Behavioral reward inhibitory control task
Tidsramme: Collected after the behavioral inhibitory control task (same visit), which is either week 1-3 (randomized)
|
Measured by performance on a go/nogo task with a reward incentive
|
Collected after the behavioral inhibitory control task (same visit), which is either week 1-3 (randomized)
|
Behavioral risk-taking and reward task
Tidsramme: Collected at either week 1-3 (randomized)
|
Measured by performance on the hungry donkey task
|
Collected at either week 1-3 (randomized)
|
Behavioral dietary self-control assessment
Tidsramme: Collected at either week 1-3 (randomized)
|
Measured by performance on a dietary self-control task
|
Collected at either week 1-3 (randomized)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Energy intake at baseline
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).
Tidsramme: 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
Tidsramme: Collected at week 4
|
Whole brain BOLD analysis of an fMRI card-guessing task for various reward types
|
Collected at week 4
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Højde
Tidsramme: Afhentes i uge 1
|
Højde i cm målt ved stadiometer
|
Afhentes i uge 1
|
Kropsfedtprocent
Tidsramme: Afhentes i uge 1
|
Vurderet ved bioelektrisk impedansanalyseskala
|
Afhentes i uge 1
|
Appetitlige træk
Tidsramme: Afhentes i uge 1
|
Forældrerapporteret spørgeskema over sædvanlige spisestile hos børn
|
Afhentes i uge 1
|
Liking of foods
Tidsramme: 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
Tidsramme: 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
Tidsramme: Collected at week 1
|
Child report of pubertal status questionnaire
|
Collected at week 1
|
Weight
Tidsramme: Collected at week 1
|
Weight in kg measured by a standard digital scale
|
Collected at week 1
|
Body mass index
Tidsramme: Collected at week 1
|
Calculated from height, age, sex
|
Collected at week 1
|
BMI percentile
Tidsramme: 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
Tidsramme: Collected at week 1
|
Calculated from height, weight, age and sex - according to CDC standards
|
Collected at week 1
|
Fat mass index
Tidsramme: Collected at week 1
|
Calculated from height, weight, age, sex
|
Collected at week 1
|
Fat-free mass index
Tidsramme: Collected at week 1
|
Calculated from height, weight, age, sex
|
Collected at week 1
|
Parental feeding strategies
Tidsramme: Collected at week 1
|
Parent-reported questionnaire of feeding practices
|
Collected at week 1
|
Family demographics
Tidsramme: Collected at week 1
|
Parent-report questionnaire
|
Collected at week 1
|
Loss of control eating
Tidsramme: 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
Tidsramme: Collected on either week 1-3 (randomized)
|
Parent and child report of inhibitory control and reward sensitivity on a questionnaire
|
Collected on either week 1-3 (randomized)
|
Age
Tidsramme: Collected at the week 1
|
Age of participant
|
Collected at the week 1
|
Sex
Tidsramme: collected at week 1
|
sex of participant
|
collected at week 1
|
Parent height
Tidsramme: collected at week 1
|
height in cm of parent measured by a stadiometer
|
collected at week 1
|
Parent weight
Tidsramme: collected at week 1
|
weight in kg of parent measured by a standard digital scale
|
collected at week 1
|
parent body fat
Tidsramme: collected at week 1
|
measured by bioelectrical impedance
|
collected at week 1
|
Puberty Assessment Parental Report
Tidsramme: Collected at week 1
|
Parent report of pubertal status questionnaire
|
Collected at week 1
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Shana Adise, B.S., The Pennsylvania State University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. april 2015
Primær færdiggørelse (Faktiske)
1. oktober 2016
Studieafslutning (Faktiske)
1. december 2017
Datoer for studieregistrering
Først indsendt
29. juni 2016
Først indsendt, der opfyldte QC-kriterier
3. august 2016
Først opslået (Skøn)
4. august 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. januar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. januar 2021
Sidst verificeret
1. januar 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DecisionMakingEatingKids01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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