Pediatric Obesity Clinical Trial
| NCT number | NCT02788838 |
| Other study ID # | CommercialEating01 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 2016 |
| Est. completion date | May 2017 |
| Verified date | January 2021 |
| Source | Penn State University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this project is to examine the impact that television food advertisements have on brain responses and eating behavior in children. Food advertisements enhance children's liking and intake of foods that tend to be high in energy content and low in nutritional value. Although several studies have measured the differences in children's food intake after watching advertisements, none have shown the brain mechanisms associated with this change in behavior. In order to clarify the relationship between food advertising and eating behavior, the investigators have assembled a team with expertise in functional imaging, eating behaviors, and clinical pediatric research. First, the investigators will observe the differences in children's eating behaviors after being exposed to food commercials or non-food commercials. Second, the investigators will measure the difference in child brain response to high and low energy foods after being exposed to food commercials or non-food commercials. These data will allow us to identify which areas of the brain are specifically affected by exposure to food commercials and correlate activity in these areas with children's measured food intake in the laboratory. Children ages 7-9 will participate in this 5-visit study which will be completed over the course of 12 months. Understanding how food advertisements impact children's brain responses and subsequent eating behaviors will have implications for understanding why some children respond differently to these cues than others. These outcomes may also inform the development of more effective programs and policies to prevent childhood obesity.
| Status | Completed |
| Enrollment | 88 |
| Est. completion date | May 2017 |
| Est. primary completion date | May 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 7 Years to 9 Years |
| Eligibility | 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 - Claustrophobic - Medication usage that may alter brain activity or blood flow - Medical disorder that may impact comfort or safety in MRI scanner - Food allergies |
| Country | Name | City | State |
|---|---|---|---|
| United States | The Pennsylvania State University | University Park | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Penn State University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Appetitive traits | Parent-reported questionnaire of habitual eating styles in children | Collected at week 1 | |
| Other | Television and Internet use and exposure | Parent and child reported questionnaires of television and internet use and exposure to shows and commercials | Collected at week 1 | |
| Other | BMI-z score | BMI-z score calculated using age, sex, weight, and height | Collected at week 1 | |
| Other | Liking and Wanting of Foods | Ratings to how much child likes and wants specific foods used in the test meals on child friendly computerized rating scale | Collected at week 1 | |
| Other | Pubertal Development | Parent reported pubertal development through questionnaire | Collected at week 1 | |
| Other | Parental feeding strategies | Parent-reported measures of feeding practices | Collected at week 1 | |
| Other | Height | Height in cm measured by stadiometer | Collected at week 1 | |
| Other | Weight | Weight in kg measured by standard digital scale | Collected at week 1 | |
| Other | Body Fat Percentage | Body Fat Percentage assessed by Bio Electrical Impedance Scale | Collected at week 1 | |
| Other | BMI | Calculated from height and weight (kg/m^2) | Collected at week 1 | |
| Primary | Functional magnetic resonance imaging (fMRI), blood oxygen level dependent (BOLD) response to high and low energy foods following food commercial priming | Whole-brain response to food images varied by 2 levels of energy viewed in 2 conditions | Collected at fMRI scan at week 4 or 5 (randomized) | |
| Primary | Functional magnetic resonance imaging, blood oxygen level dependent (BOLD) response to high and low energy foods following toy commercial priming | Energy intake of foods consumed ad libitum at each laboratory test-meal in 3 conditions | Collected at fMRI scan at week 4 or 5 (randomized) | |
| Primary | Baseline Energy Intake | Energy intake of foods consumed ad libitum at laboratory test-meal with no priming stimulus | Collected at week 1 of the study | |
| Primary | Energy Intake following food commercials | Energy intake of foods consumed ad libitum at laboratory test-meal following food commercials priming | Collected at week 2 or 3 (randomized) of the study | |
| Primary | Energy Intake following toy commercials | Energy intake of foods consumed ad libitum at laboratory test-meal following toy priming stimulus | Collected at week 2 or 3 (randomized) of the study | |
| Secondary | Region of Interest (ROI)-response to food type by condition | Response in selected regions of interest to images varied by 2 levels of energy viewed in 2 conditions | Collected at fMRI scans at weeks 4 and 5 of study |
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