Decision-Making and the Relationship to Food Intake in Kids

Pediatric Obesity Clinical Trial

— DMK  

Official title:

Understanding Decision-Making and the Relationship to Food Intake in Children 7 to 11 Years Old

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02855398
• Other study ID #: DecisionMakingEatingKids01
• Status: Completed
• Start date: April 2015
• Est. completion date: December 2017

Study information

• Verified date: January 2021
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Obesity

Locations

Country	Name	City	State
United States	The Pennsylvania State University	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Liking of foods	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
Other	Fullness feelings	Ratings of how full the child feels measured on a child-friendly visual analog scale	Collected at multiple time points during weeks 1-4
Other	Pubertal Development	Child report of pubertal status questionnaire	Collected at week 1
Other	Height	Height in cm measured by stadiometer	Collected at week 1
Other	Weight	Weight in kg measured by a standard digital scale	Collected at week 1
Other	Body fat percentage	Assessed by bioelectrical impedance analysis scale	Collected at week 1
Other	Body mass index	Calculated from height, age, sex	Collected at week 1
Other	BMI percentile	Calculated from height, weight, age and sex - according to the Center for Disease Control (CDC) standards	Collected at week 1
Other	BMI z-score	Calculated from height, weight, age and sex - according to CDC standards	Collected at week 1
Other	Fat mass index	Calculated from height, weight, age, sex	Collected at week 1
Other	Fat-free mass index	Calculated from height, weight, age, sex	Collected at week 1
Other	Appetitive traits	Parent-reported questionnaire of habitual eating styles in children	Collected at week 1
Other	Parental feeding strategies	Parent-reported questionnaire of feeding practices	Collected at week 1
Other	Family demographics	Parent-report questionnaire	Collected at week 1
Other	Loss of control eating	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
Other	Inhibitory control and reward sensitivity questionnaires	Parent and child report of inhibitory control and reward sensitivity on a questionnaire	Collected on either week 1-3 (randomized)
Other	Age	Age of participant	Collected at the week 1
Other	Sex	sex of participant	collected at week 1
Other	Parent height	height in cm of parent measured by a stadiometer	collected at week 1
Other	Parent weight	weight in kg of parent measured by a standard digital scale	collected at week 1
Other	parent body fat	measured by bioelectrical impedance	collected at week 1
Other	Puberty Assessment Parental Report	Parent report of pubertal status questionnaire	Collected at week 1
Primary	Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response to various reward types (food, money, no reward).	Regions of interest BOLD analysis of an fMRI card-guessing task for various reward types	Collected at fMRI scan at week 4
Primary	Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response at rest (resting-state fMRI)	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
Primary	Behavioral inhibitory control task	Measured by performance on a go/nogo task	Collected at either week 1-3 (randomized)
Primary	Behavioral reward inhibitory control task	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)
Primary	Behavioral risk-taking and reward task	Measured by performance on the hungry donkey task	Collected at either week 1-3 (randomized)
Primary	Behavioral dietary self-control assessment	Measured by performance on a dietary self-control task	Collected at either week 1-3 (randomized)
Secondary	Energy intake at baseline	Measured at an objective laboratory test-meal (kcal and grams)	Collected at either week 1-3 (randomized)
Secondary	Energy intake at a buffet meal	Measured at an objective laboratory test-meal (kcal and grams)	Collected at either week 1-3 (randomized)
Secondary	Energy intake after a meal preload	Measured at an objective laboratory test-meal (kcal and grams)	Collected at either week 1-3 (randomized) following the baseline meal
Secondary	Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response to various reward types (food, money, no reward).	Whole brain BOLD analysis of an fMRI card-guessing task for various reward types	Collected at week 4
Secondary	Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response at baseline	Whole brain BOLD analysis of an fMRI card-guessing task for various reward types	Collected at week 4