Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2026-03-08 @ 1:51 AM
Study NCT ID:
NCT02166892
Status:
COMPLETED
Last Update Posted:
2018-03-22
First Post:
2014-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Specially Designed Eating Plates Effects on Food Intake in Normal Weight and Overweight Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-21', 'studyFirstSubmitDate': '2014-06-09', 'studyFirstSubmitQcDate': '2014-06-16', 'lastUpdatePostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caloric intake', 'timeFrame': 'Up to 1 hour after food serving', 'description': 'The amount of food and drink consumed by the children will be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Childhood obesity', 'Plate', 'Food consumption'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'Previous studies demonstrated that children served themselves more food when using larger plates and bowels. The purpose of this study is to evaluate if self-served portions and caloric intake in normal weight and overweight children will be influenced by a specially designed eating plates compared to similar size normal plates.', 'detailedDescription': "40 normal weight and 40 overweight kindergarden and elementary school children will participate in this study.\n\nAnthropometric measurements: weight, height, BMI and BMI percentiles will be measured and calculated for each participant.\n\nThe participants will take part in two non-exercise activities at the 'sport and health center for children and adolescence'. At the end of each activity, a lunch buffet that contains all food ingredients will be served. During one meeting the children will be handed a regular plate and at the second meeting they will be handed a specially designed plate (with marking of the recommended meal composition and portion).\n\nThe amount and composition of food on the plates will be assessed by weighing and photography before and after eating and analysed to report macronutrient consumption by a dietitian. The meetings for normal weight children will be separated from the overweight children."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over weight / obese children\n* Normal weight children\n\nExclusion Criteria:\n\n* Organic disease that cause obesity\n* Underweight children (BMI percentiles \\< 5)'}, 'identificationModule': {'nctId': 'NCT02166892', 'briefTitle': 'Specially Designed Eating Plates Effects on Food Intake in Normal Weight and Overweight Children', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'The Effect of Specially Designed Eating Plates on Self-served Portions and Caloric Intake in Normal Weight and Overweight Children', 'orgStudyIdInfo': {'id': 'MeirMc0042-14CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Normal weight', 'description': 'Normal weight children will be served food in two different occasions using two sets of plates (same size). One set will be plane and the second is a specially designed plate that demonstrate the recommended food consumption and portion.', 'interventionNames': ['Other: Specially designed plates']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Overweight children', 'description': 'Overweight children will be served food in two different occasions using two sets of plates (same size). One set will be plane and the second is a specially designed plate that demonstrate the recommended food consumption and portion.', 'interventionNames': ['Other: Specially designed plates']}], 'interventions': [{'name': 'Specially designed plates', 'type': 'OTHER', 'armGroupLabels': ['Normal weight', 'Overweight children']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], 'overallOfficials': [{'name': 'Dan Nemet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meir Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dan Nemet, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dan Nemet. MD', 'investigatorFullName': 'Dan Nemet, MD', 'investigatorAffiliation': 'Meir Medical Center'}}}}