Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT05124405
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-10
First Post:
2019-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monitoring Your Exercise-related Metrics Over Time Via Wearable Electronic Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-07', 'studyFirstSubmitDate': '2019-05-20', 'studyFirstSubmitQcDate': '2021-11-15', 'lastUpdatePostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the feasibility of the ( PA) Physical Activity intervention.', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The use of CGM through the following criteria: CGM-specific refusal rate \\<20% at the participant recruitment phase and protocol adherence rates \\>80% at the end of the monitoring period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer', 'Diabetes']}, 'referencesModule': {'references': [{'pmid': '40719638', 'type': 'DERIVED', 'citation': 'Liao Y, Brannon GE, Rethorst CD, Baum M, Bevers TB, Schembre SM, Basen-Engquist KM. Using Continuous Glucose Monitoring as a Biological Feedback Strategy to Motivate Physical Activity in Cancer Survivors: A Mixed-Methods Pilot Study. Cancer Control. 2025 Jan-Dec;32:10732748251359406. doi: 10.1177/10732748251359406. Epub 2025 Jul 28.'}], 'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'M D Anderson Cancer Center website'}]}, 'descriptionModule': {'briefSummary': 'To test the use of a continuous activity and heart rate tracker (Fitbit) and continuous glucose monitor (CGM) in monitoring daily exercise-related activities.', 'detailedDescription': 'Primary objective:\n\nTo evaluate the feasibility of a CGM-based physical activity intervention that includes the use of CGM and Fitbit®.\n\nSecondary objectives:\n\nTo examine changes in physical activity motivation and other related psychosocial variables (e.g., intention, perceived benefits, outcome expectancy) before and after the intervention.\n\nExploratory objective:\n\nExamine cancer-related biomarkers and their associations with daily glucose pattern.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women at least 18 years old\n* Body mass index (BMI) 25 kg/m2\n* Engage in less than 150 minutes of moderate-intensity PA per week in the past month\n* Capable of participating in moderate-vigorous unsupervised exercise (as determined by the Physical Activity Readiness Questionnaire (PARQ) or a medical release from their physician)\n* Self-reported ability to walk one block without pain or discomfort\n* Have a smart phone with daily internet access that is compatible with the LibreLink app\n* Ability to speak, read, and write in English\n* For the cancer survivor cohort (participant accession number #21 and beyond), individuals must have been diagnosed with stage I-III breast or colorectal cancer and completed adjuvant therapy (i.e., chemo and/or radiation therapy).\n\nExclusion Criteria:\n\n* Self-reported current diagnosis or history of type 1 diabetes or type 2 diabetes\n* Self-reported use of oral antidiabetic agents (OADs)\n* Previous or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness including gestational is allowed at the discretion for the investigator)\n* Current use of a continuous glucose monitor\n* Fasting glucose \\> 125 mg/dL\n* Pregnancy\n* Self-reported health issues that limit physical activity\n* On dialysis\n* Work overnight shifts\n* Unwilling to use CGM\n* Current participation in other wellness or weight loss-related program or intervention\n* Currently on a low-carb diet\n* Unable to receive REDCap survey through their mobile phones'}, 'identificationModule': {'nctId': 'NCT05124405', 'briefTitle': 'Monitoring Your Exercise-related Metrics Over Time Via Wearable Electronic Devices', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Monitoring Your Exercise-related Metrics Over Time Via Wearable Electronic Devices', 'orgStudyIdInfo': {'id': '2018-0299'}, 'secondaryIdInfos': [{'id': 'NCI-2019-02652', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Trials Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Heart Rate Tracker (Fitbit)', 'description': 'continuous heart rate activity', 'interventionNames': ['Other: Fitbit', 'Other: Continuous Glucose Monitor']}, {'type': 'EXPERIMENTAL', 'label': 'Continuous Glucose Monitor (CGM)', 'description': 'monitoring daily exercise-related activities', 'interventionNames': ['Other: Fitbit', 'Other: Continuous Glucose Monitor']}], 'interventions': [{'name': 'Fitbit', 'type': 'OTHER', 'description': 'wearable activity tracker', 'armGroupLabels': ['Continuous Glucose Monitor (CGM)', 'Heart Rate Tracker (Fitbit)']}, {'name': 'Continuous Glucose Monitor', 'type': 'OTHER', 'description': 'wearable activity tracker', 'armGroupLabels': ['Continuous Glucose Monitor (CGM)', 'Heart Rate Tracker (Fitbit)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Karen Basen-Engquist, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}