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Pediatric ObesityDMKNCT02855398

Decision-Making and the Relationship to Food Intake in Kids

An observational study of Pediatric Obesity, run by Penn State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 7 to 11 yearsHealthy volunteers can take part
Conditions the study is for
Pediatric Obesity
How many people
142 participants
Where
1 siteUnited States
Study dates
Apr 2015to Dec 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Children aged 7-11 years old.

Who may be able to join

  • Right-handed
  • English as native language
  • Reading at/above grade level
  • Not Claustrophobic
  • Generally Healthy

Who cannot join

  • 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
Show all 9Show fewer
  • Dietary Restrictions
  • Learning Disabilities
  • Psychiatric Disorders

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Pennsylvania State University

    University Park, Pennsylvania, 16802

Other trials in United States

About this study

Official title: 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.

Medical subject headings
Pediatric Obesity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Collected at fMRI scan at week 4

  2. 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

    Measured: Collected at fMRI scan at week 4

  3. Behavioral inhibitory control task

    Measured by performance on a go/nogo task

    Measured: Collected at either week 1-3 (randomized)

  4. Behavioral reward inhibitory control task

    Measured by performance on a go/nogo task with a reward incentive

    Measured: Collected after the behavioral inhibitory control task (same visit), which is either week 1-3 (randomized)

  5. Behavioral risk-taking and reward task

    Measured by performance on the hungry donkey task

    Measured: Collected at either week 1-3 (randomized)

  6. Behavioral dietary self-control assessment

    Measured by performance on a dietary self-control task

    Measured: Collected at either week 1-3 (randomized)

Secondary outcomes (5)

  1. Energy intake at baseline

    Measured at an objective laboratory test-meal (kcal and grams)

    Measured: Collected at either week 1-3 (randomized)

  2. Energy intake at a buffet meal

    Measured at an objective laboratory test-meal (kcal and grams)

    Measured: Collected at either week 1-3 (randomized)

  3. Energy intake after a meal preload

    Measured at an objective laboratory test-meal (kcal and grams)

    Measured: Collected at either week 1-3 (randomized) following the baseline meal

  4. 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

    Measured: Collected at week 4

  5. 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

    Measured: Collected at week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2016 (estimated)
  2. Study startApr 2015
  3. Primary completionOct 2016
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02855398
Sponsor's protocol ID
DecisionMakingEatingKids01
Acronym
DMK
Status last verified
Jan 2021
First submitted
29 Jun 2016
Last updated
11 Jan 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 34324909

  • 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.

    PubMed 29890186

Questions about this trial

What is this clinical trial studying?

An observational study of Pediatric Obesity, run by Penn State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02855398, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2021.

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