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

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Other: Mobile application for personal coaching; Other: Education; Other: Mobile application for self monitoring

• Registration Number: NCT03300271
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study First Submitted: 2017-09-24
• Study First Submitted QC: 2017-09-27
• Study First Posted: 2017-10-03
• Study Start: 2017-10-28
• Primary Completion: 2018-08-02
• Study Completion: 2018-08-02
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobile Application (Personal coaching)	Mobile application for personal coaching	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.
No intervention (Education)	Education	Participants in this group is provided education. Education includes information of metabolic syndrome, methods to manage lifestyle (diet, physical activity).
Mobile Application (Self monitoring)	Mobile application for self monitoring	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.

Primary Outcome Measures

Name	Time	Method
Change in systolic/diastolic blood pressures	24 weeks	Change of systolic/diastolic blood pressures and insulin resistance are the differences between the last visit and baseline (screening visit).

Secondary Outcome Measures

Name	Time	Method
Change in the eligibility criteria for metabolic syndrome	24 weeks	Change of metabolic profiles are the differences between the last visit and baseline (screening visit).

Trial Locations

Locations (1)

Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of