Viewing Study NCT05217108


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Ignite Modification Date: 2025-12-31 @ 1:07 PM
Study NCT ID: NCT05217108
Status: RECRUITING
Last Update Posted: 2025-11-14
First Post: 2022-01-05
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: A Mobile Phone Text-based Intervention to Reduce Sedentary Behavior and Engage Communities on the Importance of Healthy Lifestyles: the TEXT2MOVE Study
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2022-01-05', 'studyFirstSubmitQcDate': '2022-01-31', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily minutes in sedentary behavior based on Fitbit data.', 'timeFrame': 'through study completion, an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Life Style', 'Healthy Lifestyle']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'M D Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'To learn if an 8-week, phone-based texting intervention program will reduce sedentary (non-mobile) behavior.', 'detailedDescription': 'Primary Objective: To test the effect of two text messaging strategies, responsive texts and standard scheduled texts, on sedentary behavior in a racially and geographically diverse sample of adults.\n\nSecondary Objective: To assess participant engagement with the program and with the educational content delivered via text messaging.\n\nExploratory Objective: To determine whether two text messaging strategies, responsive texts and standard scheduled texts, increases physical activity in a racially and geographically diverse sample of adults.\n\nExploratory Objective: To determine whether two text messaging strategies, responsive texts and standard scheduled texts are associated with changes in corresponding patient attitudes as assessed by surveys of exploring sedentary behavior, readiness for exercise change, and physical functioning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. \\>18 years old\n2. owns a smart phone\n3. has access to WiFi or willing to use mobile data\n4. has an email address or willing to create an email address\n5. able to read and understand English;\n6. able to give informed consent;\n7. willing to receive text messages and complete brief questionnaires on their smart phone\n8. self-reports sedentary behavior (\\> 6 hours/day of sitting time).\n\nExclusion criteria:\n\n1. unwilling to have sedentary behavior and activity tracked\n2. unable to walk without ambulatory assistance device (i.e. cane or walker) or due to underlying medical condition\n3. MD Anderson employees that report to the Principal Investigators of this study\n4. family or household member already enrolled into study\n5. not sedentary based on \\< 6 hours/day of sitting time, and (6) currently participating in a weight management or exercise study or program'}, 'identificationModule': {'nctId': 'NCT05217108', 'briefTitle': 'A Mobile Phone Text-based Intervention to Reduce Sedentary Behavior and Engage Communities on the Importance of Healthy Lifestyles: the TEXT2MOVE Study', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'A Mobile Phone Text-based Intervention to Reduce Sedentary Behavior and Engage Communities on the Importance of Healthy Lifestyles: the TEXT2MOVE Study', 'orgStudyIdInfo': {'id': '2021-1014'}, 'secondaryIdInfos': [{'id': 'NCI-2022-00101', 'type': 'OTHER', 'domain': 'NCI CTRP Clinical Trials Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Fit Bit (Study Groups)', 'description': 'Participants wear a Fitbit every day for 8 weeks to record the number of steps you take', 'interventionNames': ['Device: FitBit']}], 'interventions': [{'name': 'FitBit', 'type': 'DEVICE', 'description': 'All participants in each study group will receive a Fitbit. Participants will be asked to wear a Fitbit every day for 8 weeks to record the number of steps you take', 'armGroupLabels': ['Fit Bit (Study Groups)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Karen Basen-Engquist, MD', 'role': 'CONTACT', 'email': 'kbasenen@mdanderson.org', 'phone': '713-745-3123'}, {'name': 'Karen Basen-Engquist, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Karen Basen-Engquist, MD', 'role': 'CONTACT', 'email': 'kbasenen@mdanderson.org', 'phone': '(713) 745-3123'}], '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'}}}}