Effects of a Supportive Mobile Health for Life Style Modification on Blood Pressure and Insulin Resistance Improvement in People With Metabolic Abnormalities

Study Overview
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Brief Summary
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The purpose of this randomized study is to assess the efficacy of a mobile application for the improvement of blood pressure and insulin resistance in people with metabolic abnormalities.

Detailed Description
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The purpose of this randomized study is to assess the efficacy of a mobile application for the improvement of blood pressure and insulin resistance in people with metabolic syndrome. This study is a 24 week follow up randomized prevention trial. Participants visit for a screening test, then eligible participants are randomly assigned for one of the following arms; 1 intervention group using a mobile application to monitor their life style behaviors, 1 intervention group using a mobile application for personal coaching on purpose of improving their life style behavior, and 1 control group providing education about managing life style behaviors.

Official Title
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Effects of a Supportive Mobile Health for Life Style Modification on Blood Pressure and Insulin Resistance Improvement in People With Metabolic Abnormalities

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Other: Mobile application for self monitoring
* Other: Education
* Other: Mobile application for personal coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Etiologic study on cardiovascular and metabolic diseases: prospective cohort study (Severance Hospital IRB No. 4-2013-0661) participants Smartphone user Metabolic abnormality. Having 2 or more components of metabolic syndrome described below: Central obesity : waist circumference ≥ 90cm in male, ≥ 80cm in female Systolic/diastolic blood pressure ≥ 130/85 mmHg Serum triglyceride ≥ 150 mg/dL Serum high density lipoprotein cholesterol < 40 mg/dL in male, 50 mg/dL in female Fasting glucose ≥ 100mg/dL Exclusion Criteria: Presently or planning for pregnant/breastfeeding during the study. Or confirmed pregnancy by a urine test. Currently taking medication (including insulin injection) for hypertension, dyslipidemia, or diabetes. Presently using a mobile application for lifestyle modification

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to either the experimental conditions (mobile application), or the usual condition (education).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: No intervention (Education)<br>Participants in this group is provided education. Education includes information of metabolic syndrome, methods to manage lifestyle (diet, physical activity). | Other: Education<br>* Participants in this group is provided education. Education includes information of metabolic syndrome, methods to manage lifestyle (diet, physical activity).<br>|
| Experimental: Mobile Application (Self monitoring)<br>Participants in this group will be introduced to use a mobile application to self record and monitor their life style behaviors. They will be also be provided education same as the control group. | Other: Mobile application for self monitoring<br>* Participants in this group will be introduced to use a mobile application to self record and monitor their life style behaviors. They will be also be provided education same as the control group.<br>|
| Experimental: Mobile Application (Personal coaching)<br>Participants in this group will be introduced to use a mobile application. Personal coaches such as dietitian, sports manager encourage to improve their life style behaviors. They will be also be provided education same as the control group. | Other: Mobile application for personal coaching<br>* Participants in this group will be introduced to use a mobile application. Personal coaches such as dietitian, sports manager encourage to improve their life style behaviors. They will be also be provided education same as the control group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic/diastolic blood pressures | Change of systolic/diastolic blood pressures and insulin resistance are the differences between the last visit and baseline (screening visit). | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the eligibility criteria for metabolic syndrome | Change of metabolic profiles are the differences between the last visit and baseline (screening visit). | 24 weeks |