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This proposed study involves human participants who will be prospectively randomized into either 1) intervention group with a activity tracker or 2) control group without an activity tracker. In addition, the proposed study is designed to evaluate the effect of using an activity tracker on cardiovascular health in the study participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Participants in the intervention group were provided with a Fitbit wrist-worn device (Inspire 2® activity tracker) at baseline. |
|
| Control group | No Intervention | Participants in the control group did not receive a wearable device but were instructed to carry their smartphones throughout the day to enable step tracking via the MobileTrack feature. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitbit wrist-worn Inspire 2® activity tracker (Fitbit Inc., San Francisco, CA, USA) | Device | Visual feedback of the physical activity level |
|
| Measure | Description | Time Frame |
|---|---|---|
| Step Counts | Daily step counts (steps/day) were collected using the activity tracker and mobile app. | 4 weeks |
| Walking distance | Daily walking distance (meters/day) was collected using the activity tracker and mobile app. | 4 weeks |
| Energy expenditure | Daily energy expenditure (calories/day) was collected using the activity tracker and mobile app. | 4 weeks |
| Time spent in physical activity and sedentary behaviors | Time (hours : minutes) spent in physical activity and sedentary behaviors in a week was collected using the Global Physical Activity Questionnaire (GPAQ). The GPAQ consists of 16 questions designed to estimate an individual's level of physical activity in 3 domains (work, transport, and recreational activities) and time spent in sedentary behavior. | 4 weeks |
| Blood pressure | Brachial systolic and diastolic blood pressure (mmHg) was collected using an automated sphygmomanometer. Pulse pressure and mean arterial pressure were calculated from systolic and diastolic blood pressure. | 4 weeks |
| Augmentation index | Augmentation index (%), as an indicator of arterial stiffness, was assessed using applanation tonometry (SphygmoCor®, AtCor Medical, Sydney, Australia). | 4 weeks |
| Pulse wave velocity |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic measures | Fasting glucose level | 4 weeks |
| Body mass index | Body weight (kilograms) and height (meters) were measured and used to calculate body mass index (kg/m^2). |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life via survey | The quality of life was assessed using the 36-Item Short Form Health Survey (SF-36). The SF-36 consists of eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pei Tzu Wu | Pacific University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific University | Hillsboro | Oregon | 97123 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27234480 | Background | Azar KM, Koliwad S, Poon T, Xiao L, Lv N, Griggs R, Ma J. The Electronic CardioMetabolic Program (eCMP) for Patients With Cardiometabolic Risk: A Randomized Controlled Trial. J Med Internet Res. 2016 May 27;18(5):e134. doi: 10.2196/jmir.5143. | |
| 32891527 | Background | Lystrup R, Carlsen D, Sharon DJ, Crawford P. Wearable and interactive technology to share fitness goals results in weight loss but not improved diabetes outcomes. Obes Res Clin Pract. 2020 Sep-Oct;14(5):443-448. doi: 10.1016/j.orcp.2020.08.006. Epub 2020 Sep 3. |
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The study protocol and statistical analysis plan will be shared.
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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: Wearable Device on Health Promotion in Diabetes | Dec 1, 2023 | Aug 3, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Pulse wave velocity (meter/second), as an arterial stiffness indicator, was assessed using applanation tonometry (SphygmoCor®, AtCor Medical, Sydney, Australia).
| 4 weeks |
| Subendocardial viability ratio | The subendocardial viability ratio (SEVR) was measured as an index of myocardial perfusion and coronary supply-demand balance, using applanation tonometry (SphygmoCor®, AtCor Medical, Sydney, Australia). | 4 weeks |
| 4 weeks |
| Waist-to-hip ratio | Waist and hip circumferences (centimeters) were measured and used to calculate the waist-to-hip ratio. | 4 weeks |
| 4 weeks |
| 34283229 | Background | Hodkinson A, Kontopantelis E, Adeniji C, van Marwijk H, McMillian B, Bower P, Panagioti M. Interventions Using Wearable Physical Activity Trackers Among Adults With Cardiometabolic Conditions: A Systematic Review and Meta-analysis. JAMA Netw Open. 2021 Jul 1;4(7):e2116382. doi: 10.1001/jamanetworkopen.2021.16382. |