An interventional study of wearable devices to initiate behavioral intervention and 12 week wearable devices monitor in Nurse and Healthy Adult, sponsored by Tri-Service General Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by Tri-Service General Hospital · Not applicable, Interventional, and Health services research
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.
Tri-Service General Hospital is the lead sponsor of 108 studies on the registry; 11 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: wearable devices to initiate behavioral intervention
12 week wearable devices just monitor
Behavioral: 12 week wearable devices monitor
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 monitor physical activity and sleep quality only
Physical activity (subjective)
Measurement Tool: International Physical Activity Questionnaire short form - Taiwan version
Time frame: 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.
Time frame: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up
Sleep quality (objective)
Measurement Tool: Wearing Fitbit Charge 6 HR to collect physical activity and sleep quality related data.
Time frame: 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)
Time frame: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up
Body composition
Measurement Tool: Inbody 270 Body Composition Analyzer
Time frame: 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.
Time frame: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up
Plan to share: 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
Supporting information: Study protocol
Time frame: 2025/3/1 will be available and end in 2027/3/1
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