NCT02855398

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 11, 2021

Status Verified

January 1, 2021

Enrollment Period

1.5 years

First QC Date

June 29, 2016

Last Update Submit

January 7, 2021

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • Behavioral inhibitory control task

    Measured by performance on a go/nogo task

    Collected at either week 1-3 (randomized)

  • 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)

  • Behavioral risk-taking and reward task

    Measured by performance on the hungry donkey task

    Collected at either week 1-3 (randomized)

  • Behavioral dietary self-control assessment

    Measured by performance on a dietary self-control task

    Collected at either week 1-3 (randomized)

Secondary Outcomes (5)

  • Energy intake at baseline

    Collected at either week 1-3 (randomized)

  • Energy intake at a buffet meal

    Collected at either week 1-3 (randomized)

  • Energy intake after a meal preload

    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).

    Collected at week 4

  • Functional magnetic resonance imaging (fMRI), blood-oxygen-level-dependent (BOLD) response at baseline

    Collected at week 4

Other Outcomes (22)

  • Liking of foods

    Collected after each meal at multiple time points during weeks 1-4

  • Fullness feelings

    Collected at multiple time points during weeks 1-4

  • Pubertal Development

    Collected at week 1

  • +19 more other outcomes

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children aged 7-11 years old.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shana Adise, B.S.

    The Pennsylvania State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Nutritional Sciences and Food Science

Study Record Dates

First Submitted

June 29, 2016

First Posted

August 4, 2016

Study Start

April 1, 2015

Primary Completion

October 1, 2016

Study Completion

December 1, 2017

Last Updated

January 11, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations