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

NCT06814886 | Recruiting

• 1 other identifier: A202405171
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Nurse; Healthy Adult

Keywords

wearable device; behavioral change intervention; nurse; working place

Outcome Measures

Primary Outcomes (2)

• Physical activity (subjective)

  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)

  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 Outcomes (4)

• Sleep quality (objective)

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

• sleep quality (subjective)

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

• Body composition

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

• Stress

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

Study Arms (2)

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.

Behavioral: wearable devices to initiate behavioral intervention

comparison group (wearable devices monitor only)

ACTIVE COMPARATOR

12 week wearable devices just monitor

Behavioral: 12 week wearable devices monitor

Interventions

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.

Intervention group(wearable devices to initiate behavioral intervention)

12 week wearable devices monitor BEHAVIORAL

12 week wearable devices monitor physical activity and sleep quality only

comparison group (wearable devices monitor only)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, Taiwan, 114, Taiwan

RECRUITING

Central Study Contacts

YIPANG LO, PhD candidate

CONTACT

886-988-082940; winfly1017@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Nurse in emergency department, SongShan Branch

Study Record Dates

• First Submitted: December 21, 2024
• First Posted: February 7, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2025/3/1 will be available and end in 2027/3/1

Locations

TW (1)