Pilot Testing of Food Images in Children

Childhood Obesity Clinical Trial

Official title:

Pilot Testing of Food Images in Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03338634
• Other study ID #: Pilot Food Images
• Status: Active, not recruiting
• Start date: October 9, 2017
• Est. completion date: July 2023

Study information

• Verified date: April 2022
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: July 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• fMRI
• Pediatric Obesity

Locations

Country	Name	City	State
United States	Metabolic Kitchen and Children's Eating Behavior Lab	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-Scanning Questionnaire	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.	baseline
Primary	Pilot Image Description by Children	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.)	baseline
Secondary	Anthropometric Measures:weight	The parent and child will be weighed in kg.	baseline
Secondary	Anthropometric Measures:height	The height of the parent and child will be measured in meters.	baseline
Secondary	Demographic Questionnaire	The parent will complete a fill-in the blank and multiple choice demographic questionnaire. No scales are used.	baseline
Secondary	Freddy Fullness Scale Rating	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.	baseline
Secondary	CAMS anxiety scale Rating	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.	baseline

External Links

•   Dr. Kathleen Keller's current research