Clinical trial NCT02855398: Decision-Making and the Relationship to Food Intake in Kids
Official title: Understanding Decision-Making and the Relationship to Food Intake in Children 7 to 11 Years Old
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Obesity
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 142
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged 7-11 years old.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response to various reward types (food, money, no reward).
timeFrame: Collected at fMRI scan at week 4
measure: Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response at rest (resting-state fMRI)
timeFrame: Collected at fMRI scan at week 4
measure: Behavioral inhibitory control task
timeFrame: Collected at either week 1-3 (randomized)
measure: Behavioral reward inhibitory control task
timeFrame: Collected after the behavioral inhibitory control task (same visit), which is either week 1-3 (randomized)
measure: Behavioral risk-taking and reward task
timeFrame: Collected at either week 1-3 (randomized)
measure: Behavioral dietary self-control assessment
timeFrame: Collected at either week 1-3 (randomized)
Secondary outcomes:
measure: Energy intake at baseline
timeFrame: Collected at either week 1-3 (randomized)
measure: Energy intake at a buffet meal
timeFrame: Collected at either week 1-3 (randomized)
measure: Energy intake after a meal preload
timeFrame: Collected at either week 1-3 (randomized) following the baseline meal
measure: Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response to various reward types (food, money, no reward).
timeFrame: Collected at week 4
measure: Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response at baseline
timeFrame: Collected at week 4
Other outcomes:
measure: Liking of foods
timeFrame: Collected after each meal at multiple time points during weeks 1-4
measure: Fullness feelings
timeFrame: Collected at multiple time points during weeks 1-4
measure: Pubertal Development
timeFrame: Collected at week 1
measure: Height
timeFrame: Collected at week 1
measure: Weight
timeFrame: Collected at week 1
measure: Body fat percentage
timeFrame: Collected at week 1
measure: Body mass index
timeFrame: Collected at week 1
measure: BMI percentile
timeFrame: Collected at week 1
measure: BMI z-score
timeFrame: Collected at week 1
measure: Fat mass index
timeFrame: Collected at week 1
measure: Fat-free mass index
timeFrame: Collected at week 1
measure: Appetitive traits
timeFrame: Collected at week 1
measure: Parental feeding strategies
timeFrame: Collected at week 1
measure: Family demographics
timeFrame: Collected at week 1
measure: Loss of control eating
timeFrame: Collected at week 4
measure: Inhibitory control and reward sensitivity questionnaires
timeFrame: Collected on either week 1-3 (randomized)
measure: Age
timeFrame: Collected at the week 1
measure: Sex
timeFrame: collected at week 1
measure: Parent height
timeFrame: collected at week 1
measure: Parent weight
timeFrame: collected at week 1
measure: parent body fat
timeFrame: collected at week 1
measure: Puberty Assessment Parental Report
timeFrame: Collected at week 1
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: The Pennsylvania State University
name: Shana Adise, B.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.