- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02855398
Decision-Making and the Relationship to Food Intake in Kids (DMK)
7 januari 2021 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
142
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Pennsylvania
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University Park, Pennsylvania, Förenta staterna, 16802
- The Pennsylvania State University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
7 år till 11 år (Barn)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
Children aged 7-11 years old.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response to various reward types (food, money, no reward).
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Collected at either week 1-3 (randomized)
|
Measured by performance on a dietary self-control task
|
Collected at either week 1-3 (randomized)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Energy intake at baseline
Tidsram: 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
Tidsram: 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
Tidsram: 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).
Tidsram: 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
Tidsram: Collected at week 4
|
Whole brain BOLD analysis of an fMRI card-guessing task for various reward types
|
Collected at week 4
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Höjd
Tidsram: Hämtas vecka 1
|
Höjd i cm mätt med stadiometer
|
Hämtas vecka 1
|
Kroppsfettprocent
Tidsram: Hämtas vecka 1
|
Bedömd med bioelektrisk impedansanalysskala
|
Hämtas vecka 1
|
Appetitiva egenskaper
Tidsram: Hämtas vecka 1
|
Förälderrapporterat frågeformulär om vanliga ätstilar hos barn
|
Hämtas vecka 1
|
Liking of foods
Tidsram: 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
Tidsram: 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
Tidsram: Collected at week 1
|
Child report of pubertal status questionnaire
|
Collected at week 1
|
Weight
Tidsram: Collected at week 1
|
Weight in kg measured by a standard digital scale
|
Collected at week 1
|
Body mass index
Tidsram: Collected at week 1
|
Calculated from height, age, sex
|
Collected at week 1
|
BMI percentile
Tidsram: 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
Tidsram: Collected at week 1
|
Calculated from height, weight, age and sex - according to CDC standards
|
Collected at week 1
|
Fat mass index
Tidsram: Collected at week 1
|
Calculated from height, weight, age, sex
|
Collected at week 1
|
Fat-free mass index
Tidsram: Collected at week 1
|
Calculated from height, weight, age, sex
|
Collected at week 1
|
Parental feeding strategies
Tidsram: Collected at week 1
|
Parent-reported questionnaire of feeding practices
|
Collected at week 1
|
Family demographics
Tidsram: Collected at week 1
|
Parent-report questionnaire
|
Collected at week 1
|
Loss of control eating
Tidsram: 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
Tidsram: 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
Tidsram: Collected at the week 1
|
Age of participant
|
Collected at the week 1
|
Sex
Tidsram: collected at week 1
|
sex of participant
|
collected at week 1
|
Parent height
Tidsram: collected at week 1
|
height in cm of parent measured by a stadiometer
|
collected at week 1
|
Parent weight
Tidsram: collected at week 1
|
weight in kg of parent measured by a standard digital scale
|
collected at week 1
|
parent body fat
Tidsram: collected at week 1
|
measured by bioelectrical impedance
|
collected at week 1
|
Puberty Assessment Parental Report
Tidsram: Collected at week 1
|
Parent report of pubertal status questionnaire
|
Collected at week 1
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Shana Adise, B.S., The Pennsylvania State University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 april 2015
Primärt slutförande (Faktisk)
1 oktober 2016
Avslutad studie (Faktisk)
1 december 2017
Studieregistreringsdatum
Först inskickad
29 juni 2016
Först inskickad som uppfyllde QC-kriterierna
3 augusti 2016
Första postat (Uppskatta)
4 augusti 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 januari 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 januari 2021
Senast verifierad
1 januari 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- DecisionMakingEatingKids01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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