Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2026-01-20 @ 11:03 PM
Study NCT ID:
NCT01886261
Status:
COMPLETED
Last Update Posted:
2014-12-05
First Post:
2013-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Objective Measures of Place-Based Physical Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D055652', 'term': 'Gray Platelet Syndrome'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-03', 'studyFirstSubmitDate': '2013-01-15', 'studyFirstSubmitQcDate': '2013-06-21', 'lastUpdatePostDateStruct': {'date': '2014-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Construct Validity', 'timeFrame': '7 days', 'description': 'Construct validity assesses the theoretical relationship of a measure (and resulting variables) with other variables. The multitrait-multimethod matrix (MTMM) is a procedure first developed by Campbell and Fiske to asses construct validity by creating a fully crossed method-by-measure matrix of associations among multiple constructs and multiple measurement methods. The resulting matrix of correlation coefficients gives a pattern of associations that informs the validity evidence of the measure and construct. We will use the following measures in the multitrait multimethod matrix: Neighborhood Physical Activity Questionnaire, the American Timeuse Survey, and PALMS based physical activity in location estimates.'}, {'measure': 'Usability', 'timeFrame': '1 day', 'description': 'Direct observation of research staff with no experience using the PALMS system.'}, {'measure': 'Added Value', 'timeFrame': 'baseline and 1 year', 'description': 'We will be assessing GPS tracks in participants in the Fe en Accion cohort to determine the effectiveness of the place-based intervention.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['validation', 'physical activity', 'place-based interventions', 'construct validity', 'divergent validity', 'usability', 'gps', 'PALMS'], 'conditions': ['Physical Activity']}, 'descriptionModule': {'briefSummary': 'Usability of the PALMS system, validity of the PALMS system and added value to an existing cohort study.\n\nHypothesis: Addition of GPS device and use of PALMS system will allow researchers to better examine place-based interventions.', 'detailedDescription': 'The Personal Activity Location Measurement System (PALMS) researchers at UCSD have created a web-based processing system for location (GPS) and physical activity (accelerometer) data. We will collect data on a pilot sample of 40 Hispanic persons to a) test the validity of PALMS assessments of transportation modes, and activity in different locations against an objective record of activities derived from images collected by Vicon Revue; b) compare PALMS assessments of transportation modes and activity locations to other self-report measures and interview measures; c) assess the construct validity of PALMS-based activity assessment.\n\nWe will be assessing the usability of PALMS in a research staff with no previous experience of using the PALMS system. We will be assessing the added value of using PALMS to examine a place-based intervention in an existing cohort study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Validation Study: We will be recruiting 40 primarily Spanish speaking, adults from various community locations throughout San Diego County.\n\nUsability Testing:\n\nRecruiting research staff member from the SDSU Fe en Accion research study to participate in usability testing.\n\nAdded Value Cohort: Fe en Accion Participants of the Fe en Accion cohort.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Validation Study\n\nInclusion Criteria:\n\n* Adults (18+ years old)\n* Self-identify as Hispanic/Latino(a)\n* Have a variety of primary transportation modes\n* Have a variety of physical activity levels both occupational and leisure\n* Commute different distances to the location\n\nExclusion Criteria:\n\n* Illness that prevents normal activities\n* Inability to ambulate\n* Unable to wear the devices for up to 7 days\n* Unable to complete two phone interviews in English or Spanish\n* Unable to complete a written survey in English or Spanish\n\nUsability Testing:\n\nResearch staff members of the SDSU Fe en Accion research study.\n\nAdded Value Cohort: Fe en Accion\n\nInclusion Criteria (Participants of the cohort):\n\n* Attend church weekly\n* Age: 18 - 65 years old\n* Must live in San Diego County\n* Live within 4 miles of their church\n* engage in less than 150 minutes of leisure time moderate and vigorous physical activity\n* Latina woman'}, 'identificationModule': {'nctId': 'NCT01886261', 'briefTitle': 'Validation of Objective Measures of Place-Based Physical Activity', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Validation of Objective Measures of Place-Based Physical Activity', 'orgStudyIdInfo': {'id': '111274/ 121378'}, 'secondaryIdInfos': [{'id': 'R01CA167693', 'link': 'https://reporter.nih.gov/quickSearch/R01CA167693', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Kevin Patrick, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'San Diego State University', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kevin Patrick, MD, MS', 'investigatorAffiliation': 'University of California, San Diego'}}}}