Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-01 @ 5:59 AM
Study NCT ID:
NCT03165604
Status:
COMPLETED
Last Update Posted:
2018-12-06
First Post:
2017-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Information on Physical Fitness Measures and Training in Overweight Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Subjects will be given the same drink (water) in different packaging'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-05', 'studyFirstSubmitDate': '2017-04-18', 'studyFirstSubmitQcDate': '2017-05-23', 'lastUpdatePostDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Running time (seconds)', 'timeFrame': 'up to 6 weeks', 'description': 'Overall running time during aerobic treadmill fitness test'}], 'secondaryOutcomes': [{'measure': 'Maximal heart rate (beats/min)', 'timeFrame': 'up to 6 weeks', 'description': 'Maximal heart rate during aerobic treadmill fitness test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physical fitness', 'Exercise', 'Childhood Obesity', 'Information'], 'conditions': ['Childhood Obesity']}, 'referencesModule': {'references': [{'pmid': '30630461', 'type': 'DERIVED', 'citation': 'Fanti-Oren S, Birenbaum-Carmeli D, Eliakim A, Pantanowitz M, Nemet D. The effect of placebo on endurance capacity in normal weight children - a randomized trial. BMC Pediatr. 2019 Jan 10;19(1):15. doi: 10.1186/s12887-019-1394-x.'}]}, 'descriptionModule': {'briefSummary': 'In the present study the investigators will examine the impact of varying information (positive compared to standard information) concerning a drink for improving physical fitness in overweight children.', 'detailedDescription': 'The present study will explore the short and medium term effects of receiving information concerning a drink (water) (positive compared to standard information) on the physical fitness in overweight children.\n\nStudy subjects will be 30 overweight children aged 6 to 13, new participates in a nutritional, behavioral sport program,The control group of 30 normal weight children.\n\nThe first stage of the study the investigators will examine the short-term influence of different types of information concerning water on subjects\' fitness which will be measured by treadmill performance. First, the water will be presented to the participants children as an ordinary water while in the second case it will be presented as an "energy drink".\n\nThe second stage of the study will examine the impact of varying information on the subjects\' sports participation/level of physical activity over a 6 week period of training, Study subjects will be 30 over-weight children aged 6 to 13, who participate in a nutritional, behavioral sport program. During this period, information on the type of drink will be changed every week. Children will be assessed in all training sessions and their level of activity will be monitored to examine whether the information on the drink led to a different exercise behavior.\n\nThe study hypothesis is that the use of these positive information will increase participants\' fitness and levels of activity compared to standard information.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pre pubertal children\n* Study group: BMI precentiles over 85 (overweight and obese children)\n* Control group: BMI precentiles between 5-85 (normal weight children)\n\nExclusion Criteria:\n\n* Children with organic Disease\n* Competitive athlete'}, 'identificationModule': {'nctId': 'NCT03165604', 'briefTitle': 'The Effect of Information on Physical Fitness Measures and Training in Overweight Children', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'The Effect of Information on Physical Fitness Measures and Training in Overweight Children', 'orgStudyIdInfo': {'id': 'MeirMc0017-17CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Normal weight', 'description': '30 normal weight children will receive 2 types of information: standard information and positive information regarding a water drink before physical exercise', 'interventionNames': ['Other: standard information', 'Other: positive information']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Over weight', 'description': '30 over weight children will receive 2 types of information: standard information and positive information regarding a water drink before physical exercise', 'interventionNames': ['Other: standard information', 'Other: positive information']}], 'interventions': [{'name': 'standard information', 'type': 'OTHER', 'description': 'The participates will be given a standard information regarding the water drink before physical activity', 'armGroupLabels': ['Normal weight', 'Over weight']}, {'name': 'positive information', 'type': 'OTHER', 'description': 'The participates will be given positive information (the drink will be presented as an "energy" drink) regarding the drink before physical activity', 'armGroupLabels': ['Normal weight', 'Over weight']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44281', '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'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}