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

Yonsei University129 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

129

Conditions

Metabolic Syndrome

Interventions

Mobile application for self monitoringOTHER

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.

EducationOTHER

Participants in this group is provided education. Education includes information of metabolic syndrome, methods to manage lifestyle (diet, physical activity).

Mobile application for personal coachingOTHER

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: 1. Central obesity : waist circumference ≥ 90cm in male, ≥ 80cm in female 2. Systolic/diastolic blood pressure ≥ 130/85 mmHg 3. Serum triglyceride ≥ 150 mg/dL 4. Serum high density lipoprotein cholesterol \< 40 mg/dL in male, 50 mg/dL in female 5. 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

Locations (1)

Yonsei University College of Medicine

Seoul, South Korea

Outcomes

Primary Outcomes

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).

Time frame: 24 weeks

Secondary Outcomes

Change in the eligibility criteria for metabolic syndrome

Change of metabolic profiles are the differences between the last visit and baseline (screening visit).

Time frame: 24 weeks

Data from ClinicalTrials.gov

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