Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Testing of Food Images in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03338634
Recruitment Status : Active, not recruiting
First Posted : November 9, 2017
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Kathleen Loralee Keller, Penn State University

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
Childhood Obesity fMRI

Detailed Description:

The Pilot Test Session will take place in the Children's Metabolic Kitchen and Eating Behavior Lab in Chandlee Laboratory.

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Testing of Food Images in Children
Actual Study Start Date : October 9, 2017
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : July 2021

Group/Cohort
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.



Primary Outcome Measures :
  1. Pilot Image Description by Children [ Time Frame: 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 [ Time Frame: baseline ]
    The parent and child will be weighed in kg.

  2. Anthropometric Measures:height [ Time Frame: baseline ]
    The height of the parent and child will be measured in meters.

  3. Demographic Questionnaire [ Time Frame: baseline ]
    The parent will complete a fill-in the blank and multiple choice demographic questionnaire. No scales are used.

  4. Freddy Fullness Scale Rating [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Parents and their 6-10 year old children in Centre County, Pennsylvania and surrounding areas.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338634


Locations
Layout table for location information
United States, Pennsylvania
Metabolic Kitchen and Children's Eating Behavior Lab
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
Investigators
Layout table for investigator information
Principal Investigator: Kathleen L Keller, Ph.D. Penn State University
Additional Information:
Publications:
Layout table for additonal information
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: November 9, 2017    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: De-identified data will be shared with other investigators by special request made by email to the PI (Kathleen L. Keller klk37@psu.edu). For investigators who request use of the data, we will request acknowledgement of our research group and Penn State University in any public presentation of the results obtained from this study.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kathleen Loralee Keller, Penn State University:
Portion Size Effect
Childhood Obesity
fMRI
Additional relevant MeSH terms:
Layout table for MeSH terms
Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight