Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Active Comparator | Intervention group receives weekly text messages which encourage the increment of daily step count |
|
| Control group | No Intervention | Control group does not receive text message |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text messages | Other | Text messages which encourage the increment of daily step count |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in daily step count after 12 weeks of intervention | change in daily step count after 12 weeks of intervention | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| mean daily step count after 12 weeks of intervention | mean daily step count after 12 weeks of intervention | Week 12 |
| the proportion of patients who reach participant-day during the 12 weeks of intervention |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38693528 | Derived | Kim G, Kim S, Lee YB, Jin SM, Hur KY, Kim JH. A randomized controlled trial of an app-based intervention on physical activity and glycemic control in people with type 2 diabetes. BMC Med. 2024 May 1;22(1):185. doi: 10.1186/s12916-024-03408-w. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Send text messages which encourage step-by-step increment of daily step count
Not provided
Not provided
Not provided
Not provided
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
| Week 12 |
| mean daily step count at Week 24 | mean daily step count at Week 24 | Week 24 |
| the proportion of patients who reach participant-day during the Week 13-24 | the proportion of patients who reach participant-day during the Week 13-24 | Week 24 |
| the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia | 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 | the proportion of patients whose HbA1c levels <6.5% without severe hypoglycemia | Week 24 |
| HbA1c levels | HbA1c levels (%) | Week 12 |
| HbA1c levels | HbA1c levels (%) | Week 24 |
| Fasting glucose levels | Fasting glucose levels (mg/dL) | Week 12 |
| Fasting glucose levels | Fasting glucose levels (mg/dL) | Week 24 |
| Body weight | Body weight (kg) | Week 12 |
| Body weight | Body weight (kg) | Week 24 |
| Blood pressure | Blood pressure (mmHg) | Week 12 |
| Blood pressure | Blood pressure (mmHg) | Week 24 |
| IPAQ (international physical activity questionnaire) score | 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). | Week 12 |
| IPAQ (international physical activity questionnaire) score | 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). | Week 24 |
| number of recordings on personal health record application | number of recordings on personal health record application | Week 12 |
| number of recordings on personal health record application | number of recordings on personal health record application | Week 24 |
| Total cholesterol | Total cholesterol (mg/dL) | Week 12 |
| Total cholesterol | Total cholesterol (mg/dL) | Week 24 |
| High-density lipoprotein cholesterol | High-density lipoprotein cholesterol (mg/dL) | Week 12 |
| High-density lipoprotein cholesterol | High-density lipoprotein cholesterol (mg/dL) | Week 24 |
| Triglycerides | Triglycerides (mg/dL) | Week 12 |
| Triglycerides | Triglycerides (mg/dL) | Week 24 |
| low-density lipoprotein cholesterol | low-density lipoprotein cholesterol (mg/dL) | Week 12 |
| low-density lipoprotein cholesterol | low-density lipoprotein cholesterol (mg/dL) | Week 24 |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |