Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-02-20 @ 6:35 PM
Study NCT ID:
NCT02227095
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2014-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise & Overweight Children's Cognition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-04', 'studyFirstSubmitDate': '2014-04-23', 'studyFirstSubmitQcDate': '2014-08-25', 'lastUpdatePostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in physical activity outside the program', 'timeFrame': 'Baseline, 8 months, one-year follow-up', 'description': 'Youth Risk Behavior Survey questions at all 3 timepoints, accelerometry at baseline and 8 months'}, {'measure': 'Attendance to the interventions', 'timeFrame': '8 months'}, {'measure': 'Average heart rate during the exercise intervention', 'timeFrame': '8 months', 'description': 'Polar heart rate monitors will be worn by each child in the exercise intervention and downloaded after each session. Average heart rate during the session will be recorded daily. The mean for each child over the intervention period will be computed.'}, {'measure': 'Points earned during the intervention', 'timeFrame': '8 months', 'description': 'Points earned for expected behavior will be recorded daily for each child that attends the intervention. Points are redeemed for small prizes weekly.'}], 'primaryOutcomes': [{'measure': 'Change in Planning Scale scores', 'timeFrame': 'Baseline, 8 months, one-year follow-up', 'description': 'The Cognitive Assessment System provides an individually administered standardized psychological assessment of executive function'}, {'measure': 'Change in functional MRI', 'timeFrame': 'Baseline, 8 months', 'description': 'Change in blood-oxygenation level dependent (BOLD) signal reflecting brain activation during executive function tasks'}], 'secondaryOutcomes': [{'measure': 'Change in BMI', 'timeFrame': 'Baseline, 8 months, one-year follow-up', 'description': 'BMI and BMI z-score, per current norms, will be calculated'}, {'measure': 'Change in adiposity', 'timeFrame': 'Baseline, 8 months, one-year follow-up', 'description': 'Percent fat via whole-body dual-energy x-ray absorptiometry'}, {'measure': 'Change in aerobic fitness', 'timeFrame': 'Baseline, 8 months, one-year follow-up', 'description': 'VO2 peak via treadmill test'}, {'measure': 'Change in Tower of London scores', 'timeFrame': 'Baseline, 8 months, one-year follow-up', 'description': 'Individually administered standardized psychological assessment of executive function'}, {'measure': 'Change in teacher ratings of classroom behavior', 'timeFrame': 'Baseline, 8 months', 'description': 'Behavior Rating Inventory for Executive Functions-Teacher form'}, {'measure': 'Change in academic achievement', 'timeFrame': 'Baseline, 8 months, one-year follow-up', 'description': 'Woodcock-Johnson Test of Achievement III'}, {'measure': 'Change in performance on executive function tasks', 'timeFrame': 'Baseline, 8 months', 'description': 'Antisaccade and flanker tasks - error rates, interference effect'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Overweight and Obesity']}, 'referencesModule': {'references': [{'pmid': '23788510', 'type': 'RESULT', 'citation': 'Krafft CE, Schwarz NF, Chi L, Weinberger AL, Schaeffer DJ, Pierce JE, Rodrigue AL, Yanasak NE, Miller PH, Tomporowski PD, Davis CL, McDowell JE. An 8-month randomized controlled exercise trial alters brain activation during cognitive tasks in overweight children. Obesity (Silver Spring). 2014 Jan;22(1):232-42. doi: 10.1002/oby.20518. Epub 2013 Sep 10.'}, {'pmid': '24096138', 'type': 'RESULT', 'citation': 'Krafft CE, Pierce JE, Schwarz NF, Chi L, Weinberger AL, Schaeffer DJ, Rodrigue AL, Camchong J, Allison JD, Yanasak NE, Liu T, Davis CL, McDowell JE. An eight month randomized controlled exercise intervention alters resting state synchrony in overweight children. Neuroscience. 2014 Jan 3;256:445-55. doi: 10.1016/j.neuroscience.2013.09.052. Epub 2013 Oct 3.'}, {'pmid': '24457421', 'type': 'RESULT', 'citation': 'Krafft CE, Schaeffer DJ, Schwarz NF, Chi L, Weinberger AL, Pierce JE, Rodrigue AL, Allison JD, Yanasak NE, Liu T, Davis CL, McDowell JE. Improved frontoparietal white matter integrity in overweight children is associated with attendance at an after-school exercise program. Dev Neurosci. 2014;36(1):1-9. doi: 10.1159/000356219. Epub 2014 Jan 21.'}, {'pmid': '24797659', 'type': 'RESULT', 'citation': 'Schaeffer DJ, Krafft CE, Schwarz NF, Chi L, Rodrigue AL, Pierce JE, Allison JD, Yanasak NE, Liu T, Davis CL, McDowell JE. An 8-month exercise intervention alters frontotemporal white matter integrity in overweight children. Psychophysiology. 2014 Aug;51(8):728-33. doi: 10.1111/psyp.12227. Epub 2014 May 5.'}, {'pmid': '24949818', 'type': 'RESULT', 'citation': 'Schaeffer DJ, Krafft CE, Schwarz NF, Chi L, Rodrigue AL, Pierce JE, Allison JD, Yanasak NE, Liu T, Davis CL, McDowell JE. The relationship between uncinate fasciculus white matter integrity and verbal memory proficiency in children. Neuroreport. 2014 Aug 20;25(12):921-5. doi: 10.1097/WNR.0000000000000204.'}, {'pmid': '31094443', 'type': 'DERIVED', 'citation': 'Williams CF, Bustamante EE, Waller JL, Davis CL. Exercise effects on quality of life, mood, and self-worth in overweight children: the SMART randomized controlled trial. Transl Behav Med. 2019 May 16;9(3):451-459. doi: 10.1093/tbm/ibz015.'}]}, 'descriptionModule': {'briefSummary': "This research focuses on overweight, sedentary children whose health, cognition, and academic performance are therefore at risk, and who may be particularly responsive to exercise interventions.\n\nThis study will determine whether regular exercise per se (i.e. compared to attention control, or placebo, condition) benefits children's cognition and achievement, and will provide insight into neural mechanisms. A substudy will examine exercise-induced changes in brain structure.\n\nProvision of comprehensive evidence for the benefits of exercise on children's health may reduce barriers to vigorous physical activity programs during a childhood obesity epidemic by persuading policymakers, schools and communities that time spent in physical activity enhances, rather than detracts from, learning.", 'detailedDescription': 'An ancillary study adding cardiometabolic outcome measures was added (R01HL087923-02S1, http://projectreporter.nih.gov/project\\_info\\_description.cfm?aid=7880457\\&icde=20104167)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 8-11 years of age\n* Overweight or obese (BMI-for-age \\>= 85th percentile)\n* Able to participate in exercise testing and intervention\n\nExclusion Criteria:\n\n* Medical condition or medications that would interfere with measurements\n* Participation in weight control or formal exercise program outside physical education that meets more than 1 day/week\n* T-score \\> 75 on the BRIEF Behavior Regulation scale to avoid program disruption'}, 'identificationModule': {'nctId': 'NCT02227095', 'acronym': 'SMART', 'briefTitle': "Exercise & Overweight Children's Cognition", 'organization': {'class': 'OTHER', 'fullName': 'Augusta University'}, 'officialTitle': "Exercise & Overweight Children's Cognition", 'orgStudyIdInfo': {'id': 'R01HL087923', 'link': 'https://reporter.nih.gov/quickSearch/R01HL087923', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01HL087923', 'link': 'https://reporter.nih.gov/quickSearch/R01HL087923', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'After-school exercise program', 'description': '40 min/day vigorous aerobic games after school', 'interventionNames': ['Behavioral: Exercise', 'Behavioral: After-school program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sedentary after-school program', 'description': 'Attention-control condition similar to experimental condition with the exception of exercise', 'interventionNames': ['Behavioral: After-school program']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'otherNames': ['Aerobic training'], 'description': 'Heart rate monitors worn by each child at each session', 'armGroupLabels': ['After-school exercise program']}, {'name': 'After-school program', 'type': 'BEHAVIORAL', 'description': 'Supervised recreational program with token economy', 'armGroupLabels': ['After-school exercise program', 'Sedentary after-school program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Prevention Institute', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}], 'overallOfficials': [{'name': 'Catherine L Davis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Georgia, Georgia Regents University'}, {'name': 'Jennifer E McDowell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Georgia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Augusta University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'University of Georgia', 'class': 'OTHER'}, {'name': 'San Francisco State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics, Physiology & Graduate Studies', 'investigatorFullName': 'Catherine Davis', 'investigatorAffiliation': 'Augusta University'}}}}