NurseNCT06814886
Effects of Wearable Devices Initiates Behavioral Change Intervention on Body Composition, Physical Activity, Sleep Quality and Stress of Nurses in Hospital Working Place
A study testing wearable devices to initiate behavioral intervention and 12 week wearable devices monitor in people with Nurse and Healthy Adult, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
Background: Physically inactive and poor sleep quality are at increased risk for non-communicable diseases. Nurses were the most vulnerable inactive healthcare personnel who may not meet global physical activity recommendations because of complicated rotation shifts and heavy working loading. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nurse, Healthy Adult
- What is being tested?
- wearable devices to initiate behavioral intervention and 12 week wearable devices monitor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2025to 1 Mar 2027
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals who give informed consent for this study and are 20 years old or older.
- Those who own a smartphone and are willing to join the study's LINE group.
- Individuals whose mobile application (APP) can synchronize with the Fitbit Charge 6 wearable device.
- Nurses who hold a nursing license and are working in a clinical setting.
Who cannot join
- Individuals unable to provide informed consent for this study and are younger than 20 years old.
- Those who do not own a smartphone.
- Individuals who do not have a nursing license or are not employed in a clinical setting as a nurse.
- Participants who are already involved in other health promotion or exercise training studies.
- Nurses who are currently pregnant.
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
Tri-Service General Hospital
Taipei, Taiwan, 114
YIPANG LO, PhD candidate, 886-988-082940, winfly1017@hotmail.com
About this study
Official title: Effects of Wearable Devices Initiates Behavioral Change Intervention on Body Composition, Physical Activity, Sleep Quality and Stress of Nurses in Hospital Working Place: A Randomized Controlled Trial
Background: Physically inactive and poor sleep quality are at increased risk for non-communicable diseases. Nurses were the most vulnerable inactive healthcare personnel who may not meet global physical activity recommendations because of complicated rotation shifts and heavy working loading. Wearable devices initiate behavior intervention combined with smartphone applications could offer new opportunities for social connection by a convenient way for nurses to improve physical activity and sleep quality.
Objectives: To evaluate the effects of wearable devices initiate behavioral intervention on body composition, physical activity, sleep quality and stress of nurses in hospital working place.
Method: This is a randomized controlled trial that will recruit 120 nurses and randomly assign them into two groups from a hospital working place. The nurses in the intervention group will receive 12-week wearable devices to initiate behavioral intervention. The nurses in the comparison group will only receive 12-week wearable devices monitoring. Data will be collected at baseline and 12-week and 24-week follow-up. The body composition will be measured by bioelectrical impedance analysis (BIA). The physical activity and sleep quality will be monitored by the Fitbit wearable device and application. The mediator parameter of the stress will be measured by salivary amylase activity (SAA). We will control the internal validity to assure the quality of training, treatment fidelity, identify barriers and facilitators of implementation, and assess participants' satisfaction. General estimating equations (GEE) will be applied to examine the effects of time and group interaction.
- Conditions
- Nurse, Healthy Adult
- Being tested
- wearable devices to initiate behavioral intervention, 12 week wearable devices monitor
- Keywords
- wearable device, behavioral change intervention, nurse, working place
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearable devices to initiate behavioral interventionBehavioural
12 week wearable devices to initiate behavioral intervention including line APP recruited participants and give some behavior change advises, also give a APP-based motivational interviewing 15 minutes per week.
12 week wearable devices monitorBehavioural
12 week wearable devices monitor physical activity and sleep quality only
| Study group | Role | What they receive |
|---|---|---|
| Intervention group(wearable devices to initiate behavioral intervention) | Experimental | 12 week wearable devices to initiate behavioral intervention including line APP recruited participants and give some behavior change advises, also give a APP-based motivational interviewing 15 minutes per week. Receives: Behavioral: wearable devices to initiate behavioral intervention |
| comparison group (wearable devices monitor only) | Active comparator | 12 week wearable devices just monitor Receives: Behavioral: 12 week wearable devices monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity (subjective)
Measurement Tool: International Physical Activity Questionnaire short form - Taiwan version
Measured: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up
Physical activity (objective)
Measurement Tool: Wearing Fitbit Charge 6 HR to collect physical activity and sleep quality related data.
Measured: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up
Secondary outcomes (4)
Sleep quality (objective)
Measurement Tool: Wearing Fitbit Charge 6 HR to collect physical activity and sleep quality related data.
Measured: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up
sleep quality (subjective)
Measurement Tool:Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)
Measured: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up
Body composition
Measurement Tool: Inbody 270 Body Composition Analyzer
Measured: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up
Stress
Measurement Tool: Nipro Salivary Amylase Activity Monitor and enzyme-linked immunosorbent assay (ELISA) will be utilized to quantify the levels of irisin, IL-6, and BDNF in serum samples, allowing for the assessment of immune stress values.
Measured: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 May 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NurseStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LO, YIPANG, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814886
- Sponsor's protocol ID
- A202405171
- Status last verified
- Jun 2025
- First submitted
- 21 Dec 2024
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Background: Physically inactive and poor sleep quality are at increased risk for non-communicable diseases. Nurses were the most vulnerable inactive healthcare personnel who may not meet global physical activity recommendations because of complicated rotation shifts and heavy working loading. Wearable devices initiate behavior intervention combined with smartphone applications could offer new opportunities for social connection by a convenient way for nurses to improve physical activity and sleep quality. Objectives: To evaluate the effects of wearable devices initiate behavioral intervention on body composition, physical activity, sleep quality and stress of nurses in hospital working place. Method: This is a randomized controlled trial that will recruit 120 nurses and randomly assign them into two groups from a hospital working place. The nurses in the intervention group will receive 12-week wearable devices to initiate behavioral intervention. The nurses in the comparison group will
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Wearable Devices Initiates Behavioral Change Intervention on Body Composition, Physical Activity, Sleep Quality and Stress of Nurses in Hospital Working Place: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06814886
- Acronym / sponsor ID
- A202405171
- Conditions
- Nurse, Healthy Adult
- Keywords
- wearable device, behavioral change intervention, nurse, working place
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 7 Feb 2025 (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.
Background: Physically inactive and poor sleep quality are at increased risk for non-communicable diseases. Nurses were the most vulnerable inactive healthcare personnel who may not meet global physical activity recommendations because of complicated rotation shifts and heavy working loading. Wearable devices initiate behavior intervention combined with smartphone applications could offer new opportunities for social connection by a convenient way for nurses to improve physical activity and sleep quality.
Objectives: To evaluate the effects of wearable devices initiate behavioral intervention on body composition, physical activity, sleep quality and stress of nurses in hospital working place.
Method: This is a randomized controlled trial that will recruit 120 nurses and randomly assign them into two groups from a hospital working place. The nurses in the intervention group will receive 12-week wearable devices to initiate behavioral intervention. The nurses in the comparison group will only receive 12-week wearable devices monitoring. Data will be collected at baseline and 12-week and 24-week follow-up. The body composition will be measured by bioelectrical impedance analysis (BIA). The physical activity and sleep quality will be monitored by the Fitbit wearable device and application. The mediator parameter of the stress will be measured by salivary amylase activity (SAA). We will control the internal validity to assure the quality of training, treatment fidelity, identify barriers and facilitators of implementation, and assess participants' satisfaction. General estimating equations (GEE) will be applied to examine the effects of time and group interaction.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group(wearable devices to initiate behavioral intervention) | Experimental | Behavioral: wearable devices to initiate behavioral intervention12 week wearable devices to initiate behavioral intervention including line APP recruited participants and give some behavior change advises, also give a APP-based motivational interviewing 15 minutes per week. |
| comparison group (wearable devices monitor only) | Active comparator | Behavioral: 12 week wearable devices monitor12 week wearable devices just monitor |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals who give informed consent for this study and are 20 years old or older.
- Those who own a smartphone and are willing to join the study's LINE group.
- Individuals whose mobile application (APP) can synchronize with the Fitbit Charge 6 wearable device.
- Nurses who hold a nursing license and are working in a clinical setting.
Key exclusion criteria (5 listed)
- Individuals unable to provide informed consent for this study and are younger than 20 years old.
- Those who do not own a smartphone.
- Individuals who do not have a nursing license or are not employed in a clinical setting as a nurse.
- Participants who are already involved in other health promotion or exercise training studies.
- Nurses who are currently pregnant.
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 to initiate behavioral intervention12 week wearable devices to initiate behavioral intervention including line APP recruited participants and give some behavior change advises, also give a APP-based motivational interviewing 15 minutes per week. | Behavioural | Intervention group(wearable devices to initiate behavioral intervention) |
| 12 week wearable devices monitor12 week wearable devices monitor physical activity and sleep quality only | Behavioural | comparison group (wearable devices monitor only) |
Primary outcome
Physical activity (subjective)
Time frame: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up
Measurement Tool: International Physical Activity Questionnaire short form - Taiwan version
Physical activity (objective)
Time frame: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up
Measurement Tool: Wearing Fitbit Charge 6 HR to collect physical activity and sleep quality related data.
4 secondary outcomes
Sleep quality (objective)
Time frame: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up
sleep quality (subjective)
Time frame: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up
Body composition
Time frame: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up
Stress
Time frame: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up
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 24 Jun 2025.
- Individual participant dataSharing planned: Yes. Background: Physically inactive and poor sleep quality are at increased risk for non-communicable diseases. Nurses were the most vulnerable inactive healthcare personnel who may not meet global physical activity recommendations because of complicated rotation shifts and heavy working loading. Wearable devices initiate behavior intervention combined with smartphone applications could offer new opportunities for social connection by a convenient way for nurses to improve physical activity and sleep quality. Objectives: To evaluate the effects of wearable devices initiate behavioral intervention on body composition, physical activity, sleep quality and stress of nurses in hospital working place. Method: This is a randomized controlled trial that will recruit 120 nurses and randomly assign them into two groups from a hospital working place. The nurses in the intervention group will receive 12-week wearable devices to initiate behavioral intervention. The nurses in the comparison group will
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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 to initiate behavioral intervention and 12 week wearable devices monitor in people with Nurse and Healthy Adult, run by Tri-Service General Hospital (TSGH) 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 4 inclusion and 5 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 24 Jun 2025. 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 YIPANG LO, PhD candidate (886-988-082940, winfly1017@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (subjective) (time frame: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up). The study lists 2 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 24 Jun 2025.