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| ID | Type | Description | Link |
|---|---|---|---|
| 111-2410-H-005-055-MY3 | Other Identifier | National Science and Technology Council |
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The goal of this randomized controlled trial is to examine whether the use of a wearable device and social media based intention increases physical activity and enhance sleep quality among adults.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No wearable device: Control | No Intervention | The control group will not wear the device at times other than completing assessments at baseline, post-intervention, and follow-up. | |
| Intervention: Device and motivational support via social media | Experimental | 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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| Intervention: Device | Experimental | Participants in the Device group will wear the device (Garmin tracker) for a month. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable device-based intervention (with motivational support via social media) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Physical Activity | 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). | Baseline, and post-assessment (immediately after the intervention), one month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Sedentary Behavior | All participants randomized to each group with available sedentary behavior questionnaire data were included in this analysis. | Baseline, and post-assessment (immediately after the intervention), one month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Chung Hsing University | Taichung | 402 | Taiwan |
Individual participant data will not be shared with other researchers. The informed consent form signed by participants did not include provisions for data sharing outside of the study team. Therefore, we are not authorized to make the individual-level data available for secondary use.
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Eligible participants provided informed consent prior to participation. Baseline information, including demographic characteristics, physical activity levels, and sleep quality measures, was collected before group assignment. Participants were then assigned to the intervention or control group according to the study design.
Participants were recruited using a convenience sampling approach from students and staff aged 18 years or older at National Chung Hsing University through campus announcements and study advertisements.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Intervention: Device and Motivational Support Via Social Media |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2025 |
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Participants in the intervention group will wear a device and will either receive motivational support via social media or not. The control group will not wear a device during the intervention phase.
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| Wearable device-based intervention (without support) | Behavioral | 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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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.
| FG002 | Intervention: Device | Participants in the Device group will wear the device (Garmin tracker) for a month. |
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The analysis population includes all 75 participants who were randomized into the three study arms (Arm 1, Arm 2, and Arm 3) at baseline. An Intention-to-Treat (ITT) approach was employed, ensuring that all randomized individuals were accounted for in the primary and secondary outcome evaluations to minimize bias.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Intervention: Device | Participants in the Device group will wear the device (Garmin tracker) for a month. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | This summary represents the mean age and standard deviation across the three study groups to characterize the study population. | The analysis population includes all 75 participants who were randomized into the three study arms (Arm 1, Arm 2, and Arm 3) at baseline. An Intention-to-Treat (ITT) approach was employed, ensuring that all randomized individuals were accounted for in the primary and secondary outcome evaluations to minimize bias. | Mean | Standard Deviation | Years |
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| Sex: Female, Male | The gender distribution was evaluated across all three study arms prior to the one-month intervention to ensure balanced baseline characteristics. | The analysis population includes all 75 participants who were randomized into the three study arms (Arm 1, Arm 2, and Arm 3) at baseline. An Intention-to-Treat (ITT) approach was employed, ensuring that all randomized individuals were accounted for in the primary and secondary outcome evaluations to minimize bias. | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | This table summarizes the geographical distribution to confirm that the study population resides within the central Taiwan urban area. | The analysis population includes all 75 participants who were randomized into the three study arms (Arm 1, Arm 2, and Arm 3) at baseline. An Intention-to-Treat (ITT) approach was employed, ensuring that all randomized individuals were accounted for in the primary and secondary outcome evaluations to minimize bias. | Number | Participants |
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| Baseline Measurements of Participants | This baseline measurement represents the average daily sedentary time (in hours) recorded during the 1-week pre-intervention assessment period, using a Garmin wearable device. | This baseline measurement represents the average daily sedentary time, measured in hours, using a Garmin wearable device over a 1-week pre-intervention assessment period. All 75 randomized participants across the three study arms were included to establish initial sedentary behavior levels. | Mean | Standard Deviation | hours / day |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Physical Activity | 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). | All enrolled participants were included in the analysis. | Posted | Mean | Standard Deviation | steps/day | Baseline, and post-assessment (immediately after the intervention), one month follow-up |
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| Secondary | Changes in Sedentary Behavior | All participants randomized to each group with available sedentary behavior questionnaire data were included in this analysis. | Sedentary behavior was assessed using a self-reported questionnaire. The outcome represents the average sedentary time per day (hours / day) reported by participants. | Posted | Mean | Standard Deviation | hours / day | Baseline, and post-assessment (immediately after the intervention), one month follow-up |
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From enrollment to the end of the 4-week intervention period.
Adverse events were tracked during scheduled assessment points (T1 and T2), concerning on potential skin irritation from device use and musculoskeletal discomfort related to increased physical activity.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG001 | 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. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Intervention: Device | Participants in the Device group will wear the device (Garmin tracker) for a month. | 0 | 25 | 0 | 25 | 0 | 25 |
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The study was conducted at a single university using convenience sampling. The relatively small sample size and short intervention period may limit the generalizability of the findings.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Po-Wen Ku | Naitonal Chung Hsing University | +886 4 22840845 | 703 | powen.ku@nchu.edu.yw |
| Mar 17, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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