Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT01041820
Status:
COMPLETED
Last Update Posted:
2019-11-25
First Post:
2009-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Critical Periods of Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-21', 'studyFirstSubmitDate': '2009-12-30', 'studyFirstSubmitQcDate': '2009-12-31', 'lastUpdatePostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between exercise and bone marrow adipose tissue in children 3-7 years', 'timeFrame': '10 weeks of exercise'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['exercise', 'bone marrow adipose tissue', 'bone mineral density', 'Children in the intervention condition will complete a supervised physical activity program 3 days/wk for 10 weeks', 'Control treatment will be provided no intervention', 'All participants will be instructed not to change their current dietary habits during the study period.'], 'conditions': ['Metabolism']}, 'descriptionModule': {'briefSummary': "Early childhood (\\~3-7 years of age) is an important window for determining body composition trajectory and may be a critical period for the development of tissue partitioning patterns that influence obesity risk. As adiposity accelerates during this critical period, deposition/ preservation of fat stores may be sustained at the 'expense' of other tissues; i.e. energy homeostasis may be inherently biased toward fat gain. The type and amount of tissue mass accrued in early childhood has implications for metabolic profile, glucose/insulin homeostasis, hormone profile and resting energy expenditure.\n\nThe interplay between fat and bone deposition represents a physiologic trait enabling the body to choose between shuttling 'energy' towards accrual of a particular tissue. Plausibly the phenotype underlying obesity and diabetes risk may be determined by the differentiation of cell type (adipocyte, osteocyte, etc.) during this early stage of growth and development. In vitro studies demonstrate transdifferentiation under the influence of specific external stimuli, which can switch phenotypes toward other cell lineages. Further, rodent models have demonstrated that exposure to stimuli (exercise) early in life may prevent excess fat mass accrual in adulthood, even when the stimulus is later removed (animals are no longer exercising). Children's early experiences (engagement in physical activity vs. sedentary behavior) may 'environmentally induce' alterations in body composition and predispose individuals to obesity throughout life.\n\nAim 1. To examine the associations between body composition via DXA and objectively-measured physical activity/inactivity.\n\n1. Hypothesis 1.1: There is a positive association between physical activity and bone mass.\n2. Hypothesis 1.2: There is a positive association between sedentary behavior and total fat mass.\n\n Aim2. To examine the associations between adipose tissue distribution via MRI and objectively-measured physical activity/inactivity.\n3. Hypothesis 2.1: There is an inverse association between physical activity and bone marrow adipose tissue.\n4. Hypothesis 2.2: There is a positive association between sedentary behavior and bone marrow adipose tissue."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children aged 3 to 7 years\n* healthy, not under the care of a doctor\n* not taking medications known to alter body composition or metabolism'}, 'identificationModule': {'nctId': 'NCT01041820', 'briefTitle': 'Critical Periods of Exercise', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Critical Periods of Exercise', 'orgStudyIdInfo': {'id': 'F090904001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise group', 'description': 'Children will participate in a 10-week moderate to vigorous exercise program', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'non-exercising', 'description': 'Participants will receive no intervention'}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'Children will be exposed to a 10-week exercise intervention', 'armGroupLabels': ['Exercise group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35210', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Family Care Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Krista R. Casazza PhD, RD/Assistant Professor, UAB', 'investigatorFullName': 'Krista Casazza', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}