- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02855398
Decision-Making and the Relationship to Food Intake in Kids (DMK)
January 7, 2021 updated by: 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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
142
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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University Park, Pennsylvania, United States, 16802
- The Pennsylvania State University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 11 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Children aged 7-11 years old.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response to various reward types (food, money, no reward).
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
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Collected after the behavioral inhibitory control task (same visit), which is either week 1-3 (randomized)
|
|
Behavioral risk-taking and reward task
Time Frame: 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
Time Frame: Collected at either week 1-3 (randomized)
|
Measured by performance on a dietary self-control task
|
Collected at either week 1-3 (randomized)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Energy intake at baseline
Time Frame: 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
Time Frame: 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
Time Frame: 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).
Time Frame: 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
Time Frame: Collected at week 4
|
Whole brain BOLD analysis of an fMRI card-guessing task for various reward types
|
Collected at week 4
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Height
Time Frame: Collected at week 1
|
Height in cm measured by stadiometer
|
Collected at week 1
|
|
Body fat percentage
Time Frame: Collected at week 1
|
Assessed by bioelectrical impedance analysis scale
|
Collected at week 1
|
|
Appetitive traits
Time Frame: Collected at week 1
|
Parent-reported questionnaire of habitual eating styles in children
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Collected at week 1
|
|
Liking of foods
Time Frame: Collected after each meal at multiple time points during weeks 1-4
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Ratings of how much the child likes each food in the meal on a visual analog scale
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Collected after each meal at multiple time points during weeks 1-4
|
|
Fullness feelings
Time Frame: 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
Time Frame: Collected at week 1
|
Child report of pubertal status questionnaire
|
Collected at week 1
|
|
Weight
Time Frame: Collected at week 1
|
Weight in kg measured by a standard digital scale
|
Collected at week 1
|
|
Body mass index
Time Frame: Collected at week 1
|
Calculated from height, age, sex
|
Collected at week 1
|
|
BMI percentile
Time Frame: 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
Time Frame: Collected at week 1
|
Calculated from height, weight, age and sex - according to CDC standards
|
Collected at week 1
|
|
Fat mass index
Time Frame: Collected at week 1
|
Calculated from height, weight, age, sex
|
Collected at week 1
|
|
Fat-free mass index
Time Frame: Collected at week 1
|
Calculated from height, weight, age, sex
|
Collected at week 1
|
|
Parental feeding strategies
Time Frame: Collected at week 1
|
Parent-reported questionnaire of feeding practices
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Collected at week 1
|
|
Family demographics
Time Frame: Collected at week 1
|
Parent-report questionnaire
|
Collected at week 1
|
|
Loss of control eating
Time Frame: Collected at week 4
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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
Time Frame: 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
Time Frame: Collected at the week 1
|
Age of participant
|
Collected at the week 1
|
|
Sex
Time Frame: collected at week 1
|
sex of participant
|
collected at week 1
|
|
Parent height
Time Frame: collected at week 1
|
height in cm of parent measured by a stadiometer
|
collected at week 1
|
|
Parent weight
Time Frame: collected at week 1
|
weight in kg of parent measured by a standard digital scale
|
collected at week 1
|
|
parent body fat
Time Frame: collected at week 1
|
measured by bioelectrical impedance
|
collected at week 1
|
|
Puberty Assessment Parental Report
Time Frame: Collected at week 1
|
Parent report of pubertal status questionnaire
|
Collected at week 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shana Adise, B.S., The Pennsylvania State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2015
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
June 29, 2016
First Submitted That Met QC Criteria
August 3, 2016
First Posted (Estimate)
August 4, 2016
Study Record Updates
Last Update Posted (Actual)
January 11, 2021
Last Update Submitted That Met QC Criteria
January 7, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DecisionMakingEatingKids01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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