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Completed

NCT Number: NCT02855398

Decision-Making and the Relationship to Food Intake in Kids

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.

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Key information

Conditions

Pediatric Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. Behavioral inhibitory control task

    Time frame: Collected at either week 1-3 (randomized)

    Measured by performance on a go/nogo task

  4. 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

  5. Behavioral risk-taking and reward task

    Time frame: Collected at either week 1-3 (randomized)

    Measured by performance on the hungry donkey task

  6. Behavioral dietary self-control assessment

    Time frame: Collected at either week 1-3 (randomized)

    Measured by performance on a dietary self-control task

Secondary outcomes

  1. Energy intake at baseline

    Time frame: Collected at either week 1-3 (randomized)

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

  2. 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)

  3. 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)

  4. 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

  5. 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

Other outcomes

  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

  2. 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

  3. Pubertal Development

    Time frame: Collected at week 1

    Child report of pubertal status questionnaire

  4. Height

    Time frame: Collected at week 1

    Height in cm measured by stadiometer

  5. Weight

    Time frame: Collected at week 1

    Weight in kg measured by a standard digital scale

  6. Body fat percentage

    Time frame: Collected at week 1

    Assessed by bioelectrical impedance analysis scale

  7. Body mass index

    Time frame: Collected at week 1

    Calculated from height, age, sex

  8. BMI percentile

    Time frame: Collected at week 1

    Calculated from height, weight, age and sex - according to the Center for Disease Control (CDC) standards

  9. BMI z-score

    Time frame: Collected at week 1

    Calculated from height, weight, age and sex - according to CDC standards

  10. Fat mass index

    Time frame: Collected at week 1

    Calculated from height, weight, age, sex

  11. Fat-free mass index

    Time frame: Collected at week 1

    Calculated from height, weight, age, sex

  12. Appetitive traits

    Time frame: Collected at week 1

    Parent-reported questionnaire of habitual eating styles in children

  13. Parental feeding strategies

    Time frame: Collected at week 1

    Parent-reported questionnaire of feeding practices

  14. Family demographics

    Time frame: Collected at week 1

    Parent-report questionnaire

  15. 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.

  16. 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

  17. Age

    Time frame: Collected at the week 1

    Age of participant

  18. Sex

    Time frame: collected at week 1

    sex of participant

  19. Parent height

    Time frame: collected at week 1

    height in cm of parent measured by a stadiometer

  20. Parent weight

    Time frame: collected at week 1

    weight in kg of parent measured by a standard digital scale

  21. parent body fat

    Time frame: collected at week 1

    measured by bioelectrical impedance

  22. Puberty Assessment Parental Report

    Time frame: Collected at week 1

    Parent report of pubertal status questionnaire

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Official study title

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

Acronym: DMK

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Aug 4, 2016
Registry last updated
Jan 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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