Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-31 @ 10:44 PM
Study NCT ID:
NCT03338634
Status:
UNKNOWN
Last Update Posted:
2022-04-05
First Post:
2017-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Testing of Food Images in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-04', 'studyFirstSubmitDate': '2017-10-11', 'studyFirstSubmitQcDate': '2017-11-07', 'lastUpdatePostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Post-Scanning Questionnaire', 'timeFrame': 'baseline', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Pilot Image Description by Children', 'timeFrame': 'baseline', 'description': '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.)'}], 'secondaryOutcomes': [{'measure': 'Anthropometric Measures:weight', 'timeFrame': 'baseline', 'description': 'The parent and child will be weighed in kg.'}, {'measure': 'Anthropometric Measures:height', 'timeFrame': 'baseline', 'description': 'The height of the parent and child will be measured in meters.'}, {'measure': 'Demographic Questionnaire', 'timeFrame': 'baseline', 'description': 'The parent will complete a fill-in the blank and multiple choice demographic questionnaire. No scales are used.'}, {'measure': 'Freddy Fullness Scale Rating', 'timeFrame': 'baseline', 'description': '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.'}, {'measure': 'CAMS anxiety scale Rating', 'timeFrame': 'baseline', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Portion Size Effect', 'Childhood Obesity', 'fMRI'], 'conditions': ['Childhood Obesity', 'fMRI']}, 'referencesModule': {'references': [{'pmid': '21999692', 'type': 'BACKGROUND', '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.'}, {'pmid': '21291906', 'type': 'BACKGROUND', '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.'}, {'pmid': '22719753', 'type': 'BACKGROUND', '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.'}], 'seeAlsoLinks': [{'url': 'http://nutrition.hhdev.psu.edu/childrens-eating-lab', 'label': "Dr. Kathleen Keller's current research"}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nChild 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.\n\nParent Procedures: Parent's current height and weight will be obtained and he/she will complete a demographic questionnaire."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Parents and their 6-10 year old children in Centre County, Pennsylvania and surrounding areas.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child is 6 to 10 years old\n* Child is physically healthy and does not have a diagnosed learning disorder\n\nExclusion Criteria:\n\n* Child is \\< 6 or \\> 10 years old\n* Child is not physically healthy or has a diagnosed learning disorder'}, 'identificationModule': {'nctId': 'NCT03338634', 'briefTitle': 'Pilot Testing of Food Images in Children', 'organization': {'class': 'OTHER', 'fullName': 'Penn State University'}, 'officialTitle': 'Pilot Testing of Food Images in Children', 'orgStudyIdInfo': {'id': 'Pilot Food Images'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children 6 to 10', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '16802', 'city': 'University Park', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Metabolic Kitchen and Children's Eating Behavior Lab", 'geoPoint': {'lat': 40.80201, 'lon': -77.85639}}], 'overallOfficials': [{'name': 'Kathleen L Keller, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Penn State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Department of Nutritional Sciences and Food Science', 'investigatorFullName': 'Kathleen Loralee Keller', 'investigatorAffiliation': 'Penn State University'}}}}