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NCT Number: NCT06814886

Effects of Wearable Devices Initiates Behavioral Change Intervention on Body Composition, Physical Activity, Sleep Quality and Stress of Nurses in Hospital Working Place

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.

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Key information

Conditions

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tri-Service General Hospital

Taipei, Taiwan, 114

Location status: Recruiting

Location contact

YIPANG LO, PhD candidate

CONTACT

[email protected]

886-988-082940

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

wearable devices to initiate behavioral intervention

Behavioral

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

Behavioral

12 week wearable devices monitor physical activity and sleep quality only

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. Sleep quality (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.

  2. sleep quality (subjective)

    Time frame: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up

    Measurement Tool:Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)

  3. Body composition

    Time frame: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up

    Measurement Tool: Inbody 270 Body Composition Analyzer

  4. Stress

    Time frame: From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

YIPANG LO, PhD candidate

CONTACT

[email protected]

886-988-082940

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 7, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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