Physical Activity, Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes Mellitus, Physical Activity, Personal health record, Intervention
Brief summary
In this study, investigators measured the number of steps, blood pressure, blood glucose, and weight in daily life through the smartphone personal health record application for patients with type 2 diabetes. The efficacy of text message intervention, which encourages an increase in the number of steps per week for 12 weeks, on an increase in the number of daily steps and changes in glucose levels, weight, and blood pressure will be investigated. Also, the durability of intervention will be checked after 12 weeks of intervention ending.
Detailed description
This clinical study is a single institution, randomized, prospective study and monitors the average daily number of steps per week using a smartphone personal health record application developed by Samsung Medical Center for patients with type 2 diabetes. The study subjects were divided into five groups such as 1) basal activity (\<2500 steps/day), 2) limited activity (2500-4999 steps/day), 3) low activity (5000-7499 steps/day), 4) somewhat active (7500-9999 steps/day), 5) active (10000-12499 steps/day), 6) highly active (≥12500 steps/day)according to the average number of steps per day. During the 12-week period, the intervention group receives the text messages that encourage step-by-step increments every week, and the control group does not receive text messages. The effect of 12-week step monitoring and education on the change in daily step count will be analyzed. Also, the effect of change in daily step count on glucose level, body weight, and blood pressure will be studied.
Interventions
OTHERText messages
Text messages which encourage the increment of daily step count
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Send text messages which encourage step-by-step increment of daily step count
Eligibility
Sex/Gender
ALL
Age
20 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Patients with Type 2 diabetes aged 20-69 years * Patients with a HbA1c of less than 8.5% measured during screening (may be replaced by a test value within 3 months of screening visit ) * Patients who have not been prescribed diabetic medication for the past 4 weeks or who have taken more than one oral hypoglycemic agent for more than 12 weeks at a certain dose * BMI ≥ 23 kg/m2 * Available for use Samsung Galaxy S4 or later Android smartphone and wireless internet * Patients who voluntarily agreed to participate in this clinical study
Exclusion criteria
* Diabetes other than type 2 diabetes, including type 1 diabetes, gestational diabetes * Patients who are taking insulin or GLP-1 agonist other than oral hypoglycemic agent * Patients with uncontrolled chronic liver disease * Patients with acute kidney injury * Patients with psychological disorder * Patients who are taking weight lowering agent * Patients with alcohol or drug addiction within the last 3 * Patients who are taking systemic steroid * Patients who are breastfeeding or pregnant * Patients who did not voluntarily agree to the study * Patients who are unsuitable for participation in clinical research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in daily step count after 12 weeks of intervention | Week 12 | change in daily step count after 12 weeks of intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the proportion of patients who reach participant-day during the 12 weeks of intervention | Week 12 | the proportion of patients who reach participant-day during the 12 weeks of intervention The participant-day means the day the participant reach thier upper group of daily step count |
| mean daily step count at Week 24 | Week 24 | mean daily step count at Week 24 |
| the proportion of patients who reach participant-day during the Week 13-24 | Week 24 | the proportion of patients who reach participant-day during the Week 13-24 |
| the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia | Week 12 | the proportion of patients whose HbA1c levels \<6.5% without severe hypoglycemia |
| HbA1c levels | Week 12 | HbA1c levels (%) |
| Fasting glucose levels | Week 12 | Fasting glucose levels (mg/dL) |
| Body weight | Week 12 | Body weight (kg) |
| mean daily step count after 12 weeks of intervention | Week 12 | mean daily step count after 12 weeks of intervention |
| IPAQ (international physical activity questionnaire) score | Week 12 | IPAQ (international physical activity questionnaire) score are consisted of 7 questions regarding frequency of exercise, intensity of exercise, and duration of exercise. Using its automatic report, the results can be calculated as weekly physical activity level (low, intermediate, high). |
| number of recordings on personal health record application | Week 12 | number of recordings on personal health record application |
| Total cholesterol | Week 12 | Total cholesterol (mg/dL) |
| High-density lipoprotein cholesterol | Week 12 | High-density lipoprotein cholesterol (mg/dL) |
| Triglycerides | Week 12 | Triglycerides (mg/dL) |
| low-density lipoprotein cholesterol | Week 12 | low-density lipoprotein cholesterol (mg/dL) |
| Blood pressure | Week 12 | Blood pressure (mmHg) |
Countries
South Korea
Outcome results
None listed