- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06641492
A RCT Evaluating a Chatbot in Increasing Physical Activity Among Older Adults
October 12, 2024 updated by: Zixin Wang, Chinese University of Hong Kong
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
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).
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
278
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zixin Wang, Dr.
- Phone Number: +852 22528740
- Email: wangzx@cuhk.edu.hk
Study Locations
-
-
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Hong Kong, Hong Kong, 666888
- Centre for Health Behaviours Research, the Chinese University of Hong Kong
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Aged ≥65 years,
- Having a Hong Kong ID,
- Chinese speaking,
- Not meet the WHO recommended level of MVPA
- Willing to be followed by telephone at 3 and 9 months,
- Having a smartphone
- Able to send and read text/voice message via smartphone.
- Willing to wear an accelerometer for a week at T0, T1 and T2.
Exclusion Criteria:
- Blindness or deafness,
- Having been diagnosed with major psychiatric illness (schizophrenia or bipolar disorder) or dementia,
- Score ≥1 in the Chinese version of the Physical Activity Readiness Questionnaire (PAR-Q)
- Score ≤16 in the validated telephone version of the Cantonese Mini-mental State Examination (T-CMMSE)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
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.
|
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.
|
|
Active Comparator: Control
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Meeting WHO recommended level of physical activity
Time Frame: 9 months
|
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.
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zixin Wang, Dr., Centre for Health Behaviours Research, the Chinese University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 1, 2024
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
October 12, 2024
First Submitted That Met QC Criteria
October 12, 2024
First Posted (Actual)
October 15, 2024
Study Record Updates
Last Update Posted (Actual)
October 15, 2024
Last Update Submitted That Met QC Criteria
October 12, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 20210531
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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