Clinical trial NCT03338634: Pilot Testing of Food Images in Children
Official title: Pilot Testing of Food Images in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Childhood Obesity
fMRI
Keywords: Portion Size Effect
Childhood Obesity
fMRI
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents and their 6-10 year old children in Centre County, Pennsylvania and surrounding areas.

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.

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.

Eligibility 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

Primary outcomes:
measure: Pilot Image Description by Children
timeFrame: baseline
Secondary outcomes:
measure: Anthropometric Measures:weight
timeFrame: baseline
measure: Anthropometric Measures:height
timeFrame: baseline
measure: Demographic Questionnaire
timeFrame: baseline
measure: Freddy Fullness Scale Rating
timeFrame: baseline
measure: CAMS anxiety scale Rating
timeFrame: baseline
Other outcomes:
measure: Post-Scanning Questionnaire
timeFrame: baseline
Locations:
city: University Park
country: United States
facility: Metabolic Kitchen and Children's Eating Behavior Lab
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Kathleen L Keller, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.2174/1874473711104030182.
citation: 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.
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.