Physical InactivityNCT06641492
A RCT Evaluating a Chatbot in Increasing Physical Activity Among Older Adults
A study testing Chatbot-delivered interventions tailored to one's stage of changes and Chatbot-delivered standard interventions in people with Physical Inactivity, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Chatbot-delivered interventions tailored to one's stage of changes and Chatbot-delivered standard interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
Centre for Health Behaviours Research, the Chinese University of Hong Kong
Hong Kong, 666888
About this study
Official title: 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).
- Conditions
- Physical Inactivity
- Being tested
- Chatbot-delivered interventions tailored to one's stage of changes, Chatbot-delivered standard interventions
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chatbot-delivered interventions tailored to one's stage of changesBehavioural
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.
Chatbot-delivered standard interventionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Chatbot-delivered interventions tailored to one's stage of changes |
| Control | Active comparator | 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. Receives: Behavioral: Chatbot-delivered standard interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meeting WHO recommended level of physical activity
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zixin Wang, Chinese University of Hong Kong
- Investigators
- Zixin Wang, Dr., Principal investigator, Centre for Health Behaviours Research, the Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641492
- Sponsor's protocol ID
- 20210531
- Status last verified
- Oct 2024
- First submitted
- 12 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40540737
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06641492
- Acronym / sponsor ID
- 20210531
- Conditions
- Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Chatbot-delivered interventions tailored to one's stage of changesThe 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. |
| Control | Active comparator | Behavioral: Chatbot-delivered standard interventionsThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chatbot-delivered interventions tailored to one's stage of changesThe 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. | Behavioural | Intervention |
| Chatbot-delivered standard interventionsThe 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. | Behavioural | Control |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 40540737Liang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zixin Wang, Dr. principal investigator
Centre for Health Behaviours Research, the Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chatbot-delivered interventions tailored to one's stage of changes and Chatbot-delivered standard interventions in people with Physical Inactivity, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zixin Wang, Dr. (+852 22528740, wangzx@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meeting WHO recommended level of physical activity (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06641492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.