Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-01-02 @ 9:24 AM
Study NCT ID:
NCT06641492
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-15
First Post:
2024-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A RCT Evaluating a Chatbot in Increasing Physical Activity Among Older Adults
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 278}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-12', 'studyFirstSubmitDate': '2024-10-12', 'studyFirstSubmitQcDate': '2024-10-12', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Meeting WHO recommended level of physical activity', 'timeFrame': '9 months', 'description': 'Prevalence of meeting WHO recommended level of physical activity (at least 150 minutes moderate-intensity aerobic physical activity every week) at T1 (after completion of intervention) and T2 (6 months after T1). Physical activity will be measured by self-reported data and using an accelerometer.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Physical Inactivity']}, 'referencesModule': {'references': [{'pmid': '40540737', 'type': 'DERIVED', 'citation': 'Liang X, Sun F, Zhang Q, Fang Y, Yu FY, Ye D, Zhang B, Liao Q, Mo PK, Wang Z. Chatbot-Delivered Stage of Change-Tailored Web-Based Intervention to Promote Physical Activity Among Inactive Community-Dwelling People Aged 65 years or More: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jun 20;14:e68796. doi: 10.2196/68796.'}]}, 'descriptionModule': {'briefSummary': "This study will compare the efficacy of a Chatbot-delivered stage of changes (SOC)-tailored online intervention (intervention group) versus a Chatbot-delivered non-SOC-tailored online intervention in increasing the prevalence of meeting WHO recommended physical activity level six months after completion of the intervention among inactive community-dwelling individuals aged ≥65 yeas. In the intervention group, the Chatbot will assess participants' physical activity level and SOC regarding PA and automatically deliver interventions tailor to their SOC every week for 12 weeks. In the control group, the Chatbot will not assess participants' SOC. It will assess participants' physical activity level and provides a standard intervention covering general information about physical activity for older adults, which is not tailoring to participants'SOC every week for 12 weeks. All participants will be followed up after completion of the interventions (T1) and six months after T1 (T2)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥65 years,\n* Having a Hong Kong ID,\n* Chinese speaking,\n* Not meet the WHO recommended level of MVPA\n* Willing to be followed by telephone at 3 and 9 months,\n* Having a smartphone\n* Able to send and read text/voice message via smartphone.\n* Willing to wear an accelerometer for a week at T0, T1 and T2.\n\nExclusion Criteria:\n\n* Blindness or deafness,\n* Having been diagnosed with major psychiatric illness (schizophrenia or bipolar disorder) or dementia,\n* Score ≥1 in the Chinese version of the Physical Activity Readiness Questionnaire (PAR-Q)\n* Score ≤16 in the validated telephone version of the Cantonese Mini-mental State Examination (T-CMMSE)'}, 'identificationModule': {'nctId': 'NCT06641492', 'briefTitle': 'A RCT Evaluating a Chatbot in Increasing Physical Activity Among Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'A Randomized Controlled Trial Evaluating a Trans-Theoretical-Model-based Online Intervention Delivered by Fully-automated Chatbot in Increasing Physical Activity Among Inactive Community-dwelling People Aged ≥65 Years', 'orgStudyIdInfo': {'id': '20210531'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': "The Chatbot will assess participants' physical activity level and stage of changes regarding physical activity and automatically deliver interventions tailor to their stage of changes every week for 12 weeks. The Chatbot will address questions related to physical activity raised by the participants.", 'interventionNames': ["Behavioral: Chatbot-delivered interventions tailored to one's stage of changes"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': "The Chatbot will not assess participants' stage of changes. It will assess participants' physical activity level and provides a standard intervention covering general information about physical activity for older adults, which is not tailoring to participants' stage of changes every week for 12 weeks. The Chatbot will address questions related to physical activity raised by the participants.", 'interventionNames': ['Behavioral: Chatbot-delivered standard interventions']}], 'interventions': [{'name': "Chatbot-delivered interventions tailored to one's stage of changes", 'type': 'BEHAVIORAL', 'description': "The Chatbot will assess participants' physical activity level and stage of changes regarding physical activity and automatically deliver interventions tailor to their stage of changes every week for 12 weeks. The Chatbot will address questions related to physical activity raised by the participants.", 'armGroupLabels': ['Intervention']}, {'name': 'Chatbot-delivered standard interventions', 'type': 'BEHAVIORAL', 'description': "The Chatbot will not assess participants' stage of changes. It will assess participants' physical activity level and provides a standard intervention covering general information about physical activity for older adults, which is not tailoring to participants' stage of changes every week for 12 weeks. The Chatbot will address questions related to physical activity raised by the participants.", 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '666888', 'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Centre for Health Behaviours Research, the Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Zixin Wang, Dr.', 'role': 'CONTACT', 'email': 'wangzx@cuhk.edu.hk', 'phone': '+852 22528740'}], 'overallOfficials': [{'name': 'Zixin Wang, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Health Behaviours Research, the Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Zixin Wang', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}