- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03338634
Pilot Testing of Food Images in Children
Study Overview
Status
Conditions
Detailed Description
The Pilot Test Session will take place in the Children's Metabolic Kitchen and Eating Behavior Lab in Chandlee Laboratory. Up to four hundred subjects (200 children and 200 parents) may be recruited.
Child Procedures: Both Child and parent's current height and weight will be obtained. After being seated at a computer, they will complete the Children's Anxiety Meter-State (CAMS) and a Freddy Fullness pictorial hunger score. Then their ability to discriminate between portion sizes will be assessed. They will be shown several pictures of macaroni and cheese on a standard white plate with a grey tablecloth background and asked to determine which picture had a larger amount of food. Finally, they will view 180 pictures of common foods and non-food objects (office supplies). After each picture, children will be instructed to answer questions about the image (what is this image, how happy does it make you feel and how excited does it make you feel). Children will then score their hunger again with a Freddy Fullness pictorial hunger score and take a Post-Scanning Questionnaire.
Parent Procedures: Parent's current height and weight will be obtained and he/she will complete a demographic questionnaire.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Pennsylvania
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University Park, Pennsylvania, United States, 16802
- Metabolic Kitchen and Children's Eating Behavior Lab
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Child is 6 to 10 years old
- Child is physically healthy and does not have a diagnosed learning disorder
Exclusion Criteria:
- Child is < 6 or > 10 years old
- Child is not physically healthy or has a diagnosed learning disorder
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Children 6 to 10
Children must be between the ages of 6-10 years-old at the time they participate.
All children will be physically healthy and without diagnosed learning disorders.
A parent or legal guardian must be able to accompany the child.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pilot Image Description by Children
Time Frame: baseline
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Once the child is comfortable in our lab and consent has been received, they will be shown a total of 150 - 200 pictures of foods and non-food objects (e.g. office supplies).
They will also be shown control images that are blurred or scrambled versions of the test images.
After each picture, children will be instructed answer questions about the image (ex.
what is this image, how much do you like it, how large is it, etc.)
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baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anthropometric Measures:weight
Time Frame: baseline
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The parent and child will be weighed in kg.
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baseline
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Anthropometric Measures:height
Time Frame: baseline
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The height of the parent and child will be measured in meters.
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baseline
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Demographic Questionnaire
Time Frame: baseline
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The parent will complete a fill-in the blank and multiple choice demographic questionnaire.
No scales are used.
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baseline
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Freddy Fullness Scale Rating
Time Frame: baseline
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The child will complete a pictorial scale of fullness using a Freddy Scale.
This is basically a vertical slider scale, with an empty stomach equaling 0 mm and a full stomach being 150 mm.
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baseline
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CAMS anxiety scale Rating
Time Frame: baseline
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The child will complete a CAMS anxiety scale questionnaire before viewing the images.
This scale resembles a sliding scale thermometer.
When the thermometer is empty, at zero, the child is calm and not nervous or worried.
When the thermometer is full, the child is very, very nervous or worried.
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baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Post-Scanning Questionnaire
Time Frame: baseline
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After viewing the images and answering questions, children will be interviewed by the researcher to find out if they liked the procedure and whether or not they would refer their friends (to determine if other children are likely to enjoy the experience).
There is no scale, the questions require a verbal answer.
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baseline
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Burger KS, Stice E. Variability in reward responsivity and obesity: evidence from brain imaging studies. Curr Drug Abuse Rev. 2011 Sep;4(3):182-9. doi: 10.2174/1874473711104030182.
- Bruce AS, Martin LE, Savage CR. Neural correlates of pediatric obesity. Prev Med. 2011 Jun;52 Suppl 1:S29-35. doi: 10.1016/j.ypmed.2011.01.018. Epub 2011 Feb 1.
- De Silva A, Salem V, Matthews PM, Dhillo WS. The use of functional MRI to study appetite control in the CNS. Exp Diabetes Res. 2012;2012:764017. doi: 10.1155/2012/764017. Epub 2012 May 8.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pilot Food Images
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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