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

Yonsei University

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Other: Education; Other: Mobile application for personal coaching; Other: Mobile application for self monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT03300271

4-2017-0666

Details and patient eligibility

About

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.

Full 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.

Enrollment: 129 patients

Sex: All

Ages: 30 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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129 participants in 3 patient groups

No intervention (Education)

Other group

Description:

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

Treatment:

Other: Education

Mobile Application (Self monitoring)

Experimental group

Description:

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.

Treatment:

Other: Mobile application for self monitoring

Mobile Application (Personal coaching)

Experimental group

Description:

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.

Treatment:

Other: Mobile application for personal coaching