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Clinical Trials/NCT03300271
NCT03300271
Completed
Not Applicable

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

Yonsei University1 site in 1 country129 target enrollmentOctober 28, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metabolic Syndrome
Sponsor
Yonsei University
Enrollment
129
Locations
1
Primary Endpoint
Change in systolic/diastolic blood pressures
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
October 28, 2017
End Date
August 2, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in systolic/diastolic blood pressures

Time Frame: 24 weeks

Change of systolic/diastolic blood pressures and insulin resistance are the differences between the last visit and baseline (screening visit).

Secondary Outcomes

  • Change in the eligibility criteria for metabolic syndrome(24 weeks)

Study Sites (1)

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