- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02855398
Decision-Making and the Relationship to Food Intake in Kids (DMK)
7. januar 2021 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Studietype
Observasjonsmessig
Registrering (Faktiske)
142
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Pennsylvania
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University Park, Pennsylvania, Forente stater, 16802
- The Pennsylvania State University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
7 år til 11 år (Barn)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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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 |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Høyde
Tidsramme: Hentes i uke 1
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Høyde i cm målt med stadiometer
|
Hentes i uke 1
|
|
Kroppsfettprosent
Tidsramme: Hentes i uke 1
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Vurdert ved bioelektrisk impedansanalyseskala
|
Hentes i uke 1
|
|
Appetitive egenskaper
Tidsramme: Hentes i uke 1
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Foreldrerapportert spørreskjema om vanlige spisestiler hos barn
|
Hentes i uke 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Shana Adise, B.S., The Pennsylvania State University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. april 2015
Primær fullføring (Faktiske)
1. oktober 2016
Studiet fullført (Faktiske)
1. desember 2017
Datoer for studieregistrering
Først innsendt
29. juni 2016
Først innsendt som oppfylte QC-kriteriene
3. august 2016
Først lagt ut (Anslag)
4. august 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. januar 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. januar 2021
Sist bekreftet
1. januar 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DecisionMakingEatingKids01
Plan for individuelle deltakerdata (IPD)
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