Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-30 @ 12:26 PM
Study NCT ID:
NCT01264757
Status:
COMPLETED
Last Update Posted:
2016-02-05
First Post:
2010-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Steps Toward Adapting Physical Activity Guidelines for the Lower Mississippi Delta Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-04', 'studyFirstSubmitDate': '2010-12-03', 'studyFirstSubmitQcDate': '2010-12-20', 'lastUpdatePostDateStruct': {'date': '2016-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minutes spent in moderate-to-vigorous physical activity (MVPA)', 'timeFrame': 'The primary outcome is measured at baseline and after a 7-day intervention period (1 week)', 'description': 'A GT3X accelerometer is used to monitor each participants physical activity levels for seven consecutive days at baseline and again following a 7-day intervention period. The amount of time per day spent above a threshold of 2200 accelerometer counts/min is averaged over at least three days as the measure of MVPA.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pedometer', 'accelerometer', 'moderate-to-vigorous physical activity', 'adult', 'randomized trial'], 'conditions': ['Physical Inactivity']}, 'referencesModule': {'references': [{'pmid': '22046325', 'type': 'BACKGROUND', 'citation': 'Katzmarzyk PT, Champagne CM, Tudor-Locke C, Broyles ST, Harsha D, Kennedy BM, Johnson WD. A short-term physical activity randomized trial in the Lower Mississippi Delta. PLoS One. 2011;6(10):e26667. doi: 10.1371/journal.pone.0026667. Epub 2011 Oct 25.'}, {'pmid': '21854159', 'type': 'RESULT', 'citation': 'Harrington DM, Tudor-Locke C, Champagne CM, Broyles ST, Harsha DW, Kennedy BM, Johnson WD, Allen R, Katzmarzyk PT. Step-based translation of physical activity guidelines in the Lower Mississippi Delta. Appl Physiol Nutr Metab. 2011 Aug;36(4):583-5. doi: 10.1139/h11-053. Epub 2011 Aug 19.'}]}, 'descriptionModule': {'briefSummary': 'This feasibility study specifically addresses the issue of adapting US dietary guidelines physical activity recommendations to the population of the Lower Mississippi Delta. The hypothesis is that including a pedometer as a self-monitoring tool as part of adapted physical activity guidelines will result in greater immediate increases in physical activity (as monitored by an accelerometer) than an education program alone.', 'detailedDescription': 'The purpose of this study was to determine if a short-term pedometer-based intervention results in immediate increases in time spent in moderate-to-vigorous physical activity (MVPA) compared to a minimal educational intervention.A sample of 43 overweight adults 35 to 64 years of age participated in a one week pedometer-based feasibility trial monitored by accelerometry. Participants were randomized into a one-week education-only group or a group that also wore a pedometer. Accelerometer-measured MVPA was measured over 7 days at baseline and post-intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 35 to 64 years of age\n* body mass index (BMI) between 25 and 34.9 kg/m2\n* being able to walk without limitation\n\nExclusion Criteria:\n\n* cardiovascular, respiratory, gastrointestinal, neuromuscular, neurological, or psychiatric problems; musculoskeletal problems interfering with exercise\n* immunodeficiency problems\n* malignancies in the last 5 years\n* any other medical condition or life threatening disease that could be aggravated by exercise'}, 'identificationModule': {'nctId': 'NCT01264757', 'acronym': 'STEPS', 'briefTitle': 'Steps Toward Adapting Physical Activity Guidelines for the Lower Mississippi Delta Population', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'Steps Toward Adapting Physical Activity Guidelines for the Lower Mississippi Delta Population', 'orgStudyIdInfo': {'id': 'PBRC 29034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Education', 'description': 'Educational brochure about physical activity provided.', 'interventionNames': ['Behavioral: Physical Activity Educational Materials']}, {'type': 'EXPERIMENTAL', 'label': 'Pedometer', 'description': 'A pedometer was provided in addition to educational materials.', 'interventionNames': ['Behavioral: Pedometer']}], 'interventions': [{'name': 'Physical Activity Educational Materials', 'type': 'BEHAVIORAL', 'description': 'A brochure was provided to participants about the health benefits of physical activity and physical activity recommendations', 'armGroupLabels': ['Education']}, {'name': 'Pedometer', 'type': 'BEHAVIORAL', 'description': 'A pedometer was provided to participants in addition to educational materials about the health benefits of physical activity.', 'armGroupLabels': ['Pedometer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}], 'overallOfficials': [{'name': 'Peter T Katzmarzyk, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennington Biomedical Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Agriculture (USDA)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Executive Director for Population and Public Health', 'investigatorFullName': 'Peter T. Katzmarzyk', 'investigatorAffiliation': 'Pennington Biomedical Research Center'}}}}