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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • The Pennsylvania State University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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
Collected at week 1
Liking of foods
Time Frame: 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
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
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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Penn State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings