Pilot Testing of Food Images in Children

Sponsor
Penn State University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03338634
Collaborator
(none)
400
1
68.7
5.8

Study Details

Study Description

Brief Summary

This is a single, un-replicated visit to the Children's Metabolic Kitchen and Eating Behavior Lab designed to gather data on children's responses to images used in MRI studies. Additionally, a demographic questionnaire for parents will be piloted.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Pilot Testing of Food Images in Children
    Actual Study Start Date :
    Oct 9, 2017
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Jul 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Pilot Image Description by Children [baseline]

      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.)

    Secondary Outcome Measures

    1. Anthropometric Measures:weight [baseline]

      The parent and child will be weighed in kg.

    2. Anthropometric Measures:height [baseline]

      The height of the parent and child will be measured in meters.

    3. Demographic Questionnaire [baseline]

      The parent will complete a fill-in the blank and multiple choice demographic questionnaire. No scales are used.

    4. Freddy Fullness Scale Rating [baseline]

      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.

    5. CAMS anxiety scale Rating [baseline]

      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.

    Other Outcome Measures

    1. Post-Scanning Questionnaire [baseline]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Metabolic Kitchen and Children's Eating Behavior Lab University Park Pennsylvania United States 16802

    Sponsors and Collaborators

    • Penn State University

    Investigators

    • Principal Investigator: Kathleen L Keller, Ph.D., Penn State University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Kathleen Loralee Keller, Assistant Professor, Department of Nutritional Sciences and Food Science, Penn State University
    ClinicalTrials.gov Identifier:
    NCT03338634
    Other Study ID Numbers:
    • Pilot Food Images
    First Posted:
    Nov 9, 2017
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kathleen Loralee Keller, Assistant Professor, Department of Nutritional Sciences and Food Science, Penn State University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 5, 2022