- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06901037
A Pilot Randomized Controlled Trial of Chatbot Use in Older Adults for Lifestyle Change
September 8, 2025 updated by: Arkers, Wong, The Hong Kong Polytechnic University
The Acceptability and Preliminary Effectiveness of Using A Smartphone-delivered AI-Based Chatbot in Older Adults for Lifestyle Modification: A Pilot Randomized Controlled Trial
The purpose of this study is to evaluate the acceptability and preliminary effectiveness of a smartphone-delivered AI-based chatbot in promoting healthy dietary behavior and physical activity participation among older adults.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to evaluate the preliminary effectiveness of a smartphone-delivered AI-based chatbot in promoting healthy dietary behavior and physical activity participation among older adults.
It is a preliminary study with two arms.
Study Type
Interventional
Enrollment (Estimated)
84
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: Arkers Wong, PhD
- Phone Number: +85234003805
- Email: arkers.wong@polyu.edu.hk
Study Contact Backup
- Name: Qian Zhang, MSc
- Phone Number: +85264321063
- Email: melissa440.zhang@connect.polyu.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- The Hong Kong Polytechnic University
-
Contact:
- Arkers Wong, PhD
- Phone Number: +85234003805
- Email: arkers.wong@polyu.edu.hk
-
-
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
Yes
Description
Inclusion Criteria:
- aged 65 or above.
- are community-dwelling.
- are proficient in Mandarin.
- have an Internet connection.
- have at least one instant messaging app on the smartphone or agree to download one.
Exclusion Criteria:
- have any neurocognitive disorders.
- are unable to engage in moderate-intensity level of physical activity due to a preexisting medical condition.
- live with another participant who will participate in this study.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Chatbot-based intervention
Participants will immediately receive access to a 2-month chatbot-based intervention
|
A smartphone-delivered AI-based chatbot program designed to provide personalized physical activity and dietary recommendations
|
|
Other: Waitlist
Participants will be placed on a waiting list before accessing the intervention
|
A smartphone-delivered AI-based chatbot program designed to provide personalized physical activity and dietary recommendations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The acceptance of the chatbot among older adults, as measured by a 14-item simplified version of the Senior Technology Acceptance Model questionnaire
Time Frame: End of study (2 months)
|
The 14-item questionnaire uses a 10-point Likert scale, ranging from 0 (strongly disagree, very poor, very uneasy, and very unsatisfied) to 10 (strongly agree, very good, very easy, and very satisfied)
|
End of study (2 months)
|
|
The Usability of the chatbot, as measured by the System Usability Scale
Time Frame: End of study (2 months)
|
The System Usability Scale (SUS) is a 10-item Likert scale questionnaire.
The result of this survey is called SUS score, which ranges from 0 to 100 and provides information about overall customer satisfaction and usability.
A higher score indicates better usability, while a lower score may suggest usability issues.
|
End of study (2 months)
|
|
The user experience, as measured by 10 open-ended questions
Time Frame: End of study (2 months)
|
A qualitative interview will be provided to the participants for asking their experience in using chatbot.
|
End of study (2 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of dietary behavior, as measured by the intake of fruits and vegetables over the last seven days
Time Frame: Baseline, end of study (2 months)
|
We will ask them the amount of fruit and vegetable intake at baseline and end of study.
|
Baseline, end of study (2 months)
|
|
Change of walking, as measured by the Community Health Activities Model Program for Seniors questionnaire
Time Frame: Baseline, end of study (2 months)
|
The Community Health Activities Model Program for Seniors questionnaires (CHAMPS-Q) measures weekly frequency and duration of walking
|
Baseline, end of study (2 months)
|
|
Change of total activity and moderate and more vigorous physical activity variables, as measured by the CHAMPS-Q
Time Frame: Baseline, end of study (2 months)
|
The CHAMPS-Q measures weekly frequency and duration of a variety of lifestyle physical activities
|
Baseline, end of study (2 months)
|
|
Change of quality of life, as measured by the Hong Kong Quality of Life for Older Persons Scale
Time Frame: Baseline, end of study (2 months)
|
The Hong Kong Quality of Life for Older Persons Scale (HKQoLOCP) comprises a total of 21 items that can be categorized into different domains: subjective well-being, consisting of 4 items; health, comprising 5 items; interpersonal relationships, including 6 items; achievement-recognition, with 4 items; and finance and living conditions (1 item each)
|
Baseline, end of study (2 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Arkers Wong, PhD, The Hong Kong Polytechnic University
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 (Actual)
May 1, 2025
Primary Completion (Estimated)
October 30, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
March 23, 2025
First Submitted That Met QC Criteria
March 23, 2025
First Posted (Actual)
March 28, 2025
Study Record Updates
Last Update Posted (Estimated)
September 15, 2025
Last Update Submitted That Met QC Criteria
September 8, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HSEARS20250305010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No sharing of data except reasonable request.
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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