Wearable Devices on Health Promotion in Diabetes

Pacific University9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Diabetes (DM)

Interventions

Fitbit wrist-worn Inspire 2® activity tracker (Fitbit Inc., San Francisco, CA, USA)DEVICE

Visual feedback of the physical activity level

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Pacific University

Hillsboro, Oregon, United States

Outcomes

Primary Outcomes

Step Counts

Daily step counts (steps/day) were collected using the activity tracker and mobile app.

Time frame: 4 weeks

Walking distance

Daily walking distance (meters/day) was collected using the activity tracker and mobile app.

Time frame: 4 weeks

Energy expenditure

Daily energy expenditure (calories/day) was collected using the activity tracker and mobile app.

Time frame: 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.

Time frame: 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.

Time frame: 4 weeks

Augmentation index

Augmentation index (%), as an indicator of arterial stiffness, was assessed using applanation tonometry (SphygmoCor®, AtCor Medical, Sydney, Australia).

Time frame: 4 weeks

Pulse wave velocity

Pulse wave velocity (meter/second), as an arterial stiffness indicator, was assessed using applanation tonometry (SphygmoCor®, AtCor Medical, Sydney, Australia).

Time frame: 4 weeks

Data from ClinicalTrials.gov

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Wearable Devices on Health Promotion in Diabetes

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes