- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06739876
Effects of a Wearable Device and Social Media-Based Intervention on Physical Activity and Sleep Quality in Adults
Effects of a Wearable Device and Social Media-Based Intervention on Physical Activity and Sleep Quality in Adults: A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
The present study aims to study sedentary breaks and sleep quality in Taiwanese adults.
This is a three-arm randomized controlled trial, exploring the effects of a one-month wearable device-based intervention (Garmin tracker) in increasing physical activity and improving sleep quality in adults (Target n = 75 ). The one-month follow-up assessment will be conducted to examine the remaining effects of the intervention.
The main questions it aims to answer are:
Does using a wearable device improve physical activity and improve sleep quality among adults?
Does the inclusion of motivational support provided via social media promote even greater effects in increasing physical activity and improvements in sleep quality?
Researchers will compare groups wearing a device and receiving motivational support via social media (intervention group 1) or wearing a device but without support (intervention 2) to a control condition (participants who do not wear a device and do not receive support) to see whether a wearable device could increase physical activity and improve sleep.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Taichung, Taiwan, 402
- National Chung Hsing University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Those who have not used a wearable-device before.
Exclusion Criteria:
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: No wearable device: Control
The control group will not wear the device at times other than completing assessments at baseline, post-intervention, and follow-up.
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Experimental: Intervention: Device and motivational support via social media
Participants in the Device and motivational support group will wear the device (Garmin tracker) for a month.
In addition, they will receive motivational support via social media.
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The wearable device-based intervention aims to reduce sedentary behavior as the Move alert function may facilitate the management of one's physical activity.
Motivational support will be provided via an online community created using LINE platform.
The platform serve for the following purposes: a) providing psychoeduation prior to the intervention; b) providing a place for participants to motivate and encourage each other; c) provide health knowledge to participants weekly, to motivate behavioral change; d) encouraging participants to upload their daily step count to the community page to motivate each other's progress; e) based on participant's performance, research assistants will provide tailored support using Line stickers designed for the present intervention; f) research assistants will monitor participants' step counts and provide prizes (vouchers) for those who had the most step counts and made the most improvements.
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Experimental: Intervention: Device
Participants in the Device group will wear the device (Garmin tracker) for a month.
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The wearable device-based intervention aims to reduce sedentary behavior as the Move alert function may facilitate the management of one's physical activity.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in Physical Activity
Time Frame: Baseline, and post-assessment (immediately after the intervention), one month follow-up
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Change in physical activity will be assessed by self-report measure on sedentary breaks and behaviour (the measure was developed by the investigator in a previous study).
In addition, it will also be assessed by a measurable device (physical activity-related parameters assessed by Garmin monitor).
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Baseline, and post-assessment (immediately after the intervention), one month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in Sedentary Behavior
Time Frame: Baseline, and post-assessment (immediately after the intervention), one month follow-up
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All participants randomized to each group with available sedentary behavior questionnaire data were included in this analysis.
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Baseline, and post-assessment (immediately after the intervention), one month follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Satisfaction with life
Time Frame: Time Frame: Baseline, and post-assessment (immediately after the intervention), one month follow-up
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Satisfaction with life will be measured by the Satisfaction With Life Scale.
The total score will be used, ranging from the minimum value of 5 to the maximum value of 35.
Higher scores indicate higher satisfaction.
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Time Frame: Baseline, and post-assessment (immediately after the intervention), one month follow-up
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Stress
Time Frame: Time Frame: Baseline, and post-assessment (immediately after the intervention), one month follow-up
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Stress will be measured by the Perceived Stress Scale.
The total score will be used, ranging from the minimum value of 0 to 56.
A score of 0-28 indicate normal perceived stress levels, 29-42 indicate relatively high stress; a score of43-56 indicate high perceived stress.
Greater values indicate greater levels of stress.
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Time Frame: Baseline, and post-assessment (immediately after the intervention), one month follow-up
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Depressive symptoms
Time Frame: Time Frame: Baseline, and post-assessment (immediately after the intervention), one month follow-up
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Depressive symptoms will be measured by the Center for Epidemiologic Studies Depression Scale.
The total score will be used, ranging from the minimum value of 0 to the maximum value of 30.
A score of 10 or above indicate depressive symptoms.
Higher scores indicate higher levels of depressive symptoms.
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Time Frame: Baseline, and post-assessment (immediately after the intervention), one month follow-up
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCUEREC-110-082
- 111-2410-H-005-055-MY3 (Other Identifier: National Science and Technology Council)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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