Effect of Monitoring of Step Number on Diabetes

NCT ID: NCT03407222

Last Updated: 2019-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2019-11-30

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.

Conditions

Type 2 Diabetes Mellitus; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

Intervention group receives weekly text messages which encourage the increment of daily step count

Group Type: ACTIVE_COMPARATOR

Text messages

Intervention Type: OTHER

Text messages which encourage the increment of daily step count

Control group

Control group does not receive text message

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Text messages

Text messages which encourage the increment of daily step count

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jae Hyeon Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 38693528 (View on PubMed)

Other Identifiers

2017-12-052

Identifier Type: -

Identifier Source: org_study_id