Diabetes (DM)
Conditions
Brief summary
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.
Interventions
DEVICEFitbit wrist-worn Inspire 2® activity tracker (Fitbit Inc., San Francisco, CA, USA)
Visual feedback of the physical activity level
Sponsors
Pacific University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older 2. diagnosed with type 2 diabetes (HbA1c ≥ 6.5% or fasting plasma glucose ≥ 126 mg/dL) 3. willing to link a fitness tracker (Fitbit®) App to their own smartphone
Exclusion criteria
1. are unable to walk without assistive devices, 2. are current smokers, 3. are pregnant or breastfeeding, 4. already engage in ≥ 150 minutes of moderate-to-vigorous physical activity per week, 5. have any medical conditions (e.g., musculoskeletal diseases, cognitive dysfunction) that will interfere with physical activity, 6. undergo any insulin treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subendocardial viability ratio | 4 weeks | 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). |
| Time spent in physical activity and sedentary behaviors | 4 weeks | 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. |
| Blood pressure | 4 weeks | 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. |
| Augmentation index | 4 weeks | Augmentation index (%), as an indicator of arterial stiffness, was assessed using applanation tonometry (SphygmoCor®, AtCor Medical, Sydney, Australia). |
| Pulse wave velocity | 4 weeks | Pulse wave velocity (meter/second), as an arterial stiffness indicator, was assessed using applanation tonometry (SphygmoCor®, AtCor Medical, Sydney, Australia). |
| Step Counts | 4 weeks | Daily step counts (steps/day) were collected using the activity tracker and mobile app. |
| Walking distance | 4 weeks | Daily walking distance (meters/day) was collected using the activity tracker and mobile app. |
| Energy expenditure | 4 weeks | Daily energy expenditure (calories/day) was collected using the activity tracker and mobile app. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic measures | 4 weeks | Fasting glucose level |
| Body mass index | 4 weeks | Body weight (kilograms) and height (meters) were measured and used to calculate body mass index (kg/m\^2). |
| Waist-to-hip ratio | 4 weeks | Waist and hip circumferences (centimeters) were measured and used to calculate the waist-to-hip ratio. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of life via survey | 4 weeks | 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. |
Countries
United States
Outcome results
None listed