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

June 18, 2025 updated by: LO, YIPANG, Tri-Service General Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei City, Taiwan, 114
        • Recruiting
        • Tri-Service General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group(wearable devices to initiate behavioral intervention)
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 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.
Active Comparator: comparison group (wearable devices monitor only)
12 week wearable devices just monitor
Behavioral: 12 week wearable devices monitor
12 week wearable devices monitor physical activity and sleep quality only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up
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.
From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Measurement Tool:Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)
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
Measurement Tool: Inbody 270 Body Composition Analyzer
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
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.
From enrollment to the end of treatment at 12 weeks, and 24 weeks follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tri-Service General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

December 21, 2024

First Submitted That Met QC Criteria

February 2, 2025

First Posted (Actual)

February 7, 2025

Study Record Updates

Last Update Posted (Actual)

June 24, 2025

Last Update Submitted That Met QC Criteria

June 18, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A202405171

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

2025/3/1 will be available and end in 2027/3/1

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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