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OpenTrials
Completed

NCT Number: NCT03300271

Effects of a Supportive Mobile Health for Life Style Modification on Blood Pressure and Insulin Resistance Improvement 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 abnormalities.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University College of Medicine

Seoul, 03722, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile application for self monitoring

Other

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.

Education

Other

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

Mobile application for personal coaching

Other

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.

Primary outcomes

  1. 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

  1. Change in the eligibility criteria for metabolic syndrome

    Time frame: 24 weeks

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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 3, 2017
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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