A Pilot Randomized Controlled Trial of Chatbot Use in Older Adults for Lifestyle Change

September 14, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Hong Kong Polytechnic University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Chatbot-based intervention
Participants will immediately receive access to a 2-month chatbot-based intervention
Other: A 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
Other: A chatbot-based 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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