Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT03094858
Status:
WITHDRAWN
Last Update Posted:
2021-06-11
First Post:
2017-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Smartphone Intervention to Reduce Sedentary Behavior
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D040242', 'term': 'Risk Reduction Behavior'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'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'count': 0}}, 'statusModule': {'whyStopped': 'The smartwatches we planned to use were discontinued.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-10', 'studyFirstSubmitDate': '2017-02-16', 'studyFirstSubmitQcDate': '2017-03-23', 'lastUpdatePostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accelerometer-measured sedentary time', 'timeFrame': 'One week', 'description': 'Total accelerometer-measured time spent in sedentary activity'}], 'secondaryOutcomes': [{'measure': 'Accelerometer-measured sedentary breaks', 'timeFrame': '26 weeks', 'description': 'Accelerometer-measured time spent in sedentary activity'}, {'measure': 'Accelerometer-measured total active time', 'timeFrame': '26 weeks', 'description': 'Total active time'}, {'measure': 'Accelerometer-measured time spent in light, moderate, and vigorous activity', 'timeFrame': '26 weeks', 'description': 'Total time spent in light, moderate, and vigorous activity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Smartphone, sedentary behavior, smartphone intervention'], 'conditions': ['Risk Reduction Behavior']}, 'descriptionModule': {'briefSummary': 'Participants (N = 300) will be randomly assigned to: 1) an equipment-only comparison group that receives a smartphone and an activity monitor wristband but does not receive smartphone intervention prompts, or 2) the intervention group who will receive an activity monitor wristband that works in conjunction with a smartphone to reduce sedentary time via smartphone prompts during prolonged sedentary bouts. All participants will be provided with a Fitbit® wristband activity monitor and an Android smartphone on the same day of the week (i.e., Mondays). Participants will complete a 1-week baseline accelerometer and EMA period prior to the start of the intervention. Participants will be followed for 26 weeks after the intervention begins with follow-up visits at 6, 13, and 26 weeks. The primary outcome will be accelerometer-measured time spent in sedentary activity. Sedentary breaks, total active time, and time spent in light, moderate, and vigorous activity will be additionally evaluated as outcomes. Contextual variables and potential treatment mechanisms will be assessed via traditional questionnaire measurement and daily random EMAs at baseline and all follow-up visits. Brief smartphone-based daily diary assessments will be completed daily for the duration of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A score of ≥ 4 on the REALM-SF85 indicating \\> 6th grade English literacy level, must be at least 18 years of age\n* A BMI ≥ 25 (overweight/obese), not meeting current physical activity guidelines as measured by the 7-Day Physical Activity Recall\n* Do not have a contraindication for physical activity based on the Physical Activity Readiness Questionnaire (PAR-Q)\n* Able to attend all study visits, and possess a valid home address and a functioning telephone number.\n\nExclusion Criteria:\n\n* Participants who have physical disabilities that restrict lower limb function and/or reading skills below a 7th grade reading level.'}, 'identificationModule': {'nctId': 'NCT03094858', 'acronym': 'SMARTpath', 'briefTitle': 'Evaluation of a Smartphone Intervention to Reduce Sedentary Behavior', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Evaluation of a Smartphone Intervention to Reduce Sedentary Behavior', 'orgStudyIdInfo': {'id': '7092'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Comparison group', 'description': 'Equipment only comparison group will use Smartphone and Wristband to monitor sedentary behavior', 'interventionNames': ['Device: Wristband', 'Device: Smartphone']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Intervention group will receive prompts from Smartphone to reduce sedentary behavior using information from Wristband', 'interventionNames': ['Device: Smartphone with prompts', 'Device: Wristband']}], 'interventions': [{'name': 'Smartphone with prompts', 'type': 'DEVICE', 'otherNames': ['Android Smartphone'], 'description': 'Smartphone will be used to prompt randomly selected participants in intervention group to be active', 'armGroupLabels': ['Intervention group']}, {'name': 'Wristband', 'type': 'DEVICE', 'otherNames': ['Fitbit'], 'description': 'Wristband will monitor activity of all participants', 'armGroupLabels': ['Comparison group', 'Intervention group']}, {'name': 'Smartphone', 'type': 'DEVICE', 'otherNames': ['Android'], 'description': 'Smartphone will be used to monitor activity but prompts will not be given to randomly selected participants', 'armGroupLabels': ['Comparison group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Darla Kendzor, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}