Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-27 @ 4:06 PM
Study NCT ID:
NCT01699295
Status:
COMPLETED
Last Update Posted:
2016-01-12
First Post:
2012-10-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity and Academic Achievement Across the Curriculum (A+PAAC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 584}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-09', 'studyFirstSubmitDate': '2012-10-01', 'studyFirstSubmitQcDate': '2012-10-01', 'lastUpdatePostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Academic Achievement in Elementary Students', 'timeFrame': 'Baseline to 3 Years', 'description': 'Changes in academic achievement between students in elementary schools that participate in a program that delivers academic lessons taught through MVPA (A+PAAC) to students in elementary schools that do not receive academic lessons taught through MVPA (CON)'}], 'secondaryOutcomes': [{'measure': 'Assessment of Cognitive Function', 'timeFrame': 'Baseline to 3 Years', 'description': 'Changes in attentional control and academic achievement'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'Baseline to 3 Years', 'description': 'Change in the BMI over course of the study.'}, {'measure': 'Cardiovascular (CV) Fitness and Daily Physical Activity (PA)', 'timeFrame': 'Baseline to 3 Years', 'description': 'Changes in CV Fitness and PA and its impact on cognitive control of attention and academic achievement'}, {'measure': 'Change in Attention-to-Task', 'timeFrame': 'Baseline to 3 Years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['academic achievement', 'elementary school', 'physical activity', 'exercise'], 'conditions': ['Intelligence', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '27392380', 'type': 'DERIVED', 'citation': 'Honas JJ, Willis EA, Herrmann SD, Greene JL, Washburn RA, Donnelly JE. Energy Expenditure and Intensity of Classroom Physical Activity in Elementary School Children. J Phys Act Health. 2016 Jun;13(6 Suppl 1):S53-6. doi: 10.1123/jpah.2015-0717.'}, {'pmid': '25647532', 'type': 'DERIVED', 'citation': 'Willis EA, Ptomey LT, Szabo-Reed AN, Honas JJ, Lee J, Washburn RA, Donnelly JE. Length of moderate-to-vigorous physical activity bouts and cardio-metabolic risk factors in elementary school children. Prev Med. 2015 Apr;73:76-80. doi: 10.1016/j.ypmed.2015.01.022. Epub 2015 Jan 31.'}, {'pmid': '24781896', 'type': 'DERIVED', 'citation': "Hansen DM, Herrmann SD, Lambourne K, Lee J, Donnelly JE. Linear/nonlinear relations of activity and fitness with children's academic achievement. Med Sci Sports Exerc. 2014 Dec;46(12):2279-85. doi: 10.1249/MSS.0000000000000362."}, {'pmid': '23565969', 'type': 'DERIVED', 'citation': 'Donnelly JE, Greene JL, Gibson CA, Sullivan DK, Hansen DM, Hillman CH, Poggio J, Mayo MS, Smith BK, Lambourne K, Herrmann SD, Scudder M, Betts JL, Honas JJ, Washburn RA. Physical activity and academic achievement across the curriculum (A + PAAC): rationale and design of a 3-year, cluster-randomized trial. BMC Public Health. 2013 Apr 8;13:307. doi: 10.1186/1471-2458-13-307.'}]}, 'descriptionModule': {'briefSummary': 'There is currently considerable interest in both improving academic achievement (No Child Left Behind) and reducing the rates of obesity and its associated negative health consequences in elementary school students. Increased physical activity (PA) offers a potential intervention to address both issues. Evidence is available which suggests an association of PA with both academic achievement and obesity, and an association between obesity and academic achievement.\n\nTo provide increased PA while maintaining academic instruction time, we developed a program we call "Physical Activity Across the Curriculum" (PAAC) in which regular classroom teachers were trained to deliver academic lessons using moderate to vigorous physical activity (MVPA) for 20 minutes/d, 5 days/wk. This study is looking to compare academic achievement between students in elementary schools that participate in academic lessons taught through MVPA (PAAC) to students that do not (CON).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Grade 2 or 3 Student at one of the randomly selected elementary schools\n* Students that agree to complete assessments\n* Signed parental consent form\n* Signed child assent form\n\nExclusion Criteria:\n\n* Students that do not agree to complete assessments'}, 'identificationModule': {'nctId': 'NCT01699295', 'acronym': 'A+PAAC', 'briefTitle': 'Physical Activity and Academic Achievement Across the Curriculum (A+PAAC)', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Physical Activity and Academic Achievement Across the Curriculum (A+PAAC)', 'orgStudyIdInfo': {'id': '13460'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A+PAAC', 'description': 'Lessons delivered using A+PAAC', 'interventionNames': ['Behavioral: A+PAAC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CON', 'description': 'Regular sedentary lessons', 'interventionNames': ['Behavioral: CON']}], 'interventions': [{'name': 'A+PAAC', 'type': 'BEHAVIORAL', 'description': 'academic lessons delivered by regular classroom teachers using moderate to vigorous physical activity (MVPA) for 20 minutes/day, 5 days/week.', 'armGroupLabels': ['A+PAAC']}, {'name': 'CON', 'type': 'BEHAVIORAL', 'description': 'lessons taught by regular classroom teachers using traditional/regular sedentary lessons', 'armGroupLabels': ['CON']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Joseph Donnelly, EDD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joseph Donnelly', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Joseph Donnelly', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}