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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03300271
• Other study ID #: 4-2017-0666
• Status: Completed
• Phase: N/A
• Start date: October 28, 2017
• Est. completion date: August 2, 2018

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: August 2, 2018
• Est. primary completion date: August 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Other:
• 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.
• Education
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
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.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	24 weeks
Secondary	Change in the eligibility criteria for metabolic syndrome	Change of metabolic profiles are the differences between the last visit and baseline (screening visit).	24 weeks