Health Behavior ChangeNCT06423014
Smart mHealth Strategy for Physical Activity and Health Promotion
A study testing Wearable devices only, Wearable devices with the 1st behavior change technique and Wearable devices with the 2nd behavior change technique in people with Health Behavior Change and Wearable Technology, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
The purpose of this study is to develop a Smart mHealth Strategy that delivers behavior change techniques through wearable physical activity trackers and social media chatbots, including self-monitoring, real-time feedback and reminders, goal-setting, competition and rewards, social support, and health coaching. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior Change, Wearable Technology, Chatbot
- What is being tested?
- Wearable devices only, Wearable devices with the 1st behavior change technique and Wearable devices with the 2nd behavior change technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2023to Dec 2026
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults who is the age of majority, with insufficient physical activity, and a sedentary lifestyle who have smartphones
Who cannot join
- Individuals' health conditions may affect physical activity in daily living and the experiment, such as disability, serious health problems
- There are unconventional life plans during the experiment, such as going abroad for vacation, pregnancy, and surgery.
- Individuals have using experiences in any wearable physical activity trackers in the past six months ④ People who have ever had severe allergies to any wearable device ⑤ Professional athletes or student-athletes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University
Taipei, 110
Hsin-Yen Yen, PhD, 886-2-2736-1661 ext. 6326, kenji@tmu.edu.tw
About this study
Official title: Smart mHealth Strategy in the Delivery of Behavior Change Techniques for Physical Activity and Health Promotion
The purpose of this study is to develop a Smart mHealth Strategy that delivers behavior change techniques through wearable physical activity trackers and social media chatbots, including self-monitoring, real-time feedback and reminders, goal-setting, competition and rewards, social support, and health coaching. This study also aims to explore the effect of the Smart mHealth Strategy on the behavioral outcomes and psychological factors of physical activity, and physical and mental health. The study design is a three-stage randomized controlled trial. In each stage, 120 are recruited and randomly assigned to control and experimental groups. Participants are adults with insufficient physical activity and a sedentary lifestyle. The Smart mHealth Strategy uses smartwatches and self-developed chatbots. The constrained dialogue content is designed to finally deliver the six behavior change techniques. Data are collected in the pre-, mid-, and post-tests. The measurement includes self-administered questionnaires, Actigraphy GT9X, Inbody 270S, OMRON HEM-7130, and heart rate variability monitors.
- Being tested
- Wearable devices only, Wearable devices with the 1st behavior change technique, Wearable devices with the 2nd behavior change technique, Wearable devices with the 3rd behavior change technique, Wearable devices with the 4th behavior change technique
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable devices onlyBehavioural
self-monitoring
Wearable devices with the 1st behavior change techniqueBehavioural
reminder
Wearable devices with the 2nd behavior change techniqueBehavioural
social support
Wearable devices with the 3rd behavior change techniqueBehavioural
Competition
Wearable devices with the 4th behavior change techniqueBehavioural
Goal-setting
Wearable devices with the 5th behavior change techniqueBehavioural
health coach
Wearable devices with all behavior change techniquesBehavioural
Self-monitoring, health coach, goal-setting, competition, social support, and reminder
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Wearable devices only | Active comparator | Not described Receives: Behavioral: Wearable devices only; Behavioral: Wearable devices with the 1st behavior change technique; Behavioral: Wearable devices with the 2nd behavior change technique; Behavioral: Wearable devices with the 3rd behavior change technique; Behavioral: Wearable devices with the 4th behavior change technique; Behavioral: Wearable devices with the 5th behavior change technique; Behavioral: Wearable devices with all behavior change techniques |
| Wearable devices with the 1st behavior change technique | Experimental | Not described Receives: Behavioral: Wearable devices only; Behavioral: Wearable devices with all behavior change techniques |
| Wearable devices with the 2nd behavior change technique | Experimental | Not described Receives: Behavioral: Wearable devices only; Behavioral: Wearable devices with all behavior change techniques |
| Wearable devices with the 3rd behavior change technique | Experimental | Not described Receives: Behavioral: Wearable devices only; Behavioral: Wearable devices with all behavior change techniques |
| Wearable devices with the 4th behavior change technique | Experimental | Not described Receives: Behavioral: Wearable devices only; Behavioral: Wearable devices with all behavior change techniques |
| Wearable devices with the 5th behavior change technique | Experimental | Not described Receives: Behavioral: Wearable devices only; Behavioral: Wearable devices with all behavior change techniques |
| Wearable devices with all behavior change techniques | Experimental | Not described Receives: Behavioral: Wearable devices only; Behavioral: Wearable devices with all behavior change techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective physical activity
International Physical Activity Questionnaire (IPAQ-SF, MET-minute/week)
Measured: up to 12 weeks
Objective physical activity
Actigraphy GT9X and GT3X (MET-minute/week)
Measured: up to 12 weeks
Exercise Benefits/Barriers Scale-Concise (EBBS-C)
Higher score higher benefits and barriers
Measured: up to 12 weeks
Exercise self-efficacy scale (EXSE)
Higher score higher self-efficacy
Measured: up to 12 weeks
Physical Activity Self-Regulation Scale (PASR)
Higher score higher Self-Regulation
Measured: up to 12 weeks
Behavioural Regulation in Exercise Questionnaire (BREQ-3)
Higher score higher Behavioural Regulation
Measured: up to 12 weeks
Secondary outcomes (5)
body composition (Inbody)
Body mass index (BMI, kg/m^2), skeletal muscle index (SMI, kg/m^2), body fat percentage (%), body fat mass (kg), and fat-free mass (kg)
Measured: up to 12 weeks
blood pressure
Systolic and diastolic blood pressure (mmHg)
Measured: up to 12 weeks
heart rate variability
Total power (TP, 0-0.5 Hz), low-frequency power (LF, 0.04-0.15 Hz), high-frequency power (HF, 0.15-0.40 Hz), the ratio of low frequency to high frequency (LF/HF), and the standard deviation of all normal-to-normal intervals (SDNN)
Measured: up to 12 weeks
Depression Anxiety Stress Scale (DASS)
Higher score worse mental health
Measured: up to 12 weeks
World Health Organization Quality of Life Scale (WHOQOL-BREF)
Higher score higher Quality of Life
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 May 2023
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Behavior ChangeStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423014
- Sponsor's protocol ID
- N202303041
- Status last verified
- Mar 2024
- First submitted
- 8 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart mHealth Strategy in the Delivery of Behavior Change Techniques for Physical Activity and Health Promotion
- ClinicalTrials.gov ID
- NCT06423014
- Acronym / sponsor ID
- N202303041
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 May 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.
The purpose of this study is to develop a Smart mHealth Strategy that delivers behavior change techniques through wearable physical activity trackers and social media chatbots, including self-monitoring, real-time feedback and reminders, goal-setting, competition and rewards, social support, and health coaching. This study also aims to explore the effect of the Smart mHealth Strategy on the behavioral outcomes and psychological factors of physical activity, and physical and mental health. The study design is a three-stage randomized controlled trial. In each stage, 120 are recruited and randomly assigned to control and experimental groups. Participants are adults with insufficient physical activity and a sedentary lifestyle. The Smart mHealth Strategy uses smartwatches and self-developed chatbots. The constrained dialogue content is designed to finally deliver the six behavior change techniques. Data are collected in the pre-, mid-, and post-tests. The measurement includes self-administered questionnaires, Actigraphy GT9X, Inbody 270S, OMRON HEM-7130, and heart rate variability monitors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Wearable devices only | Active comparator | Behavioral: Wearable devices only, Behavioral: Wearable devices with the 1st behavior change technique, Behavioral: Wearable devices with the 2nd behavior change technique, Behavioral: Wearable devices with the 3rd behavior change technique, Behavioral: Wearable devices with the 4th behavior change technique, Behavioral: Wearable devices with the 5th behavior change technique, Behavioral: Wearable devices with all behavior change techniques |
| Wearable devices with the 1st behavior change technique | Experimental | Behavioral: Wearable devices only, Behavioral: Wearable devices with all behavior change techniques |
| Wearable devices with the 2nd behavior change technique | Experimental | Behavioral: Wearable devices only, Behavioral: Wearable devices with all behavior change techniques |
| Wearable devices with the 3rd behavior change technique | Experimental | Behavioral: Wearable devices only, Behavioral: Wearable devices with all behavior change techniques |
| Wearable devices with the 4th behavior change technique | Experimental | Behavioral: Wearable devices only, Behavioral: Wearable devices with all behavior change techniques |
| Wearable devices with the 5th behavior change technique | Experimental | Behavioral: Wearable devices only, Behavioral: Wearable devices with all behavior change techniques |
| Wearable devices with all behavior change techniques | Experimental | Behavioral: Wearable devices only, Behavioral: Wearable devices with all behavior change techniques |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults who is the age of majority, with insufficient physical activity, and a sedentary lifestyle who have smartphones
Key exclusion criteria (3 listed)
- Individuals' health conditions may affect physical activity in daily living and the experiment, such as disability, serious health problems
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 |
|---|---|---|
| Wearable devices onlyself-monitoring | Behavioural | Wearable devices only, Wearable devices with all behavior change techniques, Wearable devices with the 1st behavior change technique, Wearable devices with the 2nd behavior change technique, Wearable devices with the 3rd behavior change technique, Wearable devices with the 4th behavior change technique, Wearable devices with the 5th behavior change technique |
| Wearable devices with the 1st behavior change techniquereminder | Behavioural | Wearable devices only |
| Wearable devices with the 2nd behavior change techniquesocial support | Behavioural | Wearable devices only |
| Wearable devices with the 3rd behavior change techniqueCompetition | Behavioural | Wearable devices only |
| Wearable devices with the 4th behavior change techniqueGoal-setting | Behavioural | Wearable devices only |
| Wearable devices with the 5th behavior change techniquehealth coach | Behavioural | Wearable devices only |
| Wearable devices with all behavior change techniquesSelf-monitoring, health coach, goal-setting, competition, social support, and reminder | Behavioural | Wearable devices only, Wearable devices with all behavior change techniques, Wearable devices with the 1st behavior change technique, Wearable devices with the 2nd behavior change technique, Wearable devices with the 3rd behavior change technique, Wearable devices with the 4th behavior change technique, Wearable devices with the 5th behavior change technique |
Primary outcome
Subjective physical activity
Time frame: up to 12 weeks
International Physical Activity Questionnaire (IPAQ-SF, MET-minute/week)
Objective physical activity
Time frame: up to 12 weeks
Actigraphy GT9X and GT3X (MET-minute/week)
Exercise Benefits/Barriers Scale-Concise (EBBS-C)
Time frame: up to 12 weeks
Higher score higher benefits and barriers
Exercise self-efficacy scale (EXSE)
Time frame: up to 12 weeks
Higher score higher self-efficacy
Physical Activity Self-Regulation Scale (PASR)
Time frame: up to 12 weeks
Higher score higher Self-Regulation
Behavioural Regulation in Exercise Questionnaire (BREQ-3)
Time frame: up to 12 weeks
Higher score higher Behavioural Regulation
5 secondary outcomes
body composition (Inbody)
Time frame: up to 12 weeks
blood pressure
Time frame: up to 12 weeks
heart rate variability
Time frame: up to 12 weeks
Depression Anxiety Stress Scale (DASS)
Time frame: up to 12 weeks
World Health Organization Quality of Life Scale (WHOQOL-BREF)
Time frame: up to 12 weeks
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 21 May 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable devices only, Wearable devices with the 1st behavior change technique and Wearable devices with the 2nd behavior change technique in people with Health Behavior Change and Wearable Technology, run by Taipei Medical University at 1 site in Taiwan.
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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 21 May 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 Taiwan. 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 Hsin-Yen Yen, PhD (886-2-2736-1661 ext. 6326, kenji@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective physical activity (time frame: up to 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2024.