Clinical trial NCT06814886: Effects of Wearable Devices Initiates Behavioral Change Intervention on Body Composition, Physical Activity, Sleep Quality and Stress of Nurses in Hospital Working Place
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nurse
Healthy Adult
Keywords: wearable device
behavioral change intervention
nurse
working place
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Physical activity (subjective)
timeFrame: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up
measure: Physical activity (objective)
timeFrame: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up
Secondary outcomes:
measure: Sleep quality (objective)
timeFrame: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up
measure: sleep quality (subjective)
timeFrame: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up
measure: Body composition
timeFrame: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up
measure: Stress
timeFrame: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
References: