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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT03300271

Collaborator

(none)

129

Enrollment

Location

Arms

9.1

Actual Duration (Months)

14.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Other: Mobile application for self monitoring Other: Education Other: Mobile application for personal coaching	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

129 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomly assigned to either the experimental conditions (mobile application), or the usual condition (education).Participants will be randomly assigned to either the experimental conditions (mobile application), or the usual condition (education).

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

A designated researcher will be responsible for the random allocation and mask the results, so the investigators and the outcomes assessor do know the which group the participants are been allocated in.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 28, 2017

Actual Primary Completion Date :

Aug 2, 2018

Actual Study Completion Date :

Aug 2, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: No intervention (Education) Participants in this group is provided education. Education includes information of metabolic syndrome, methods to manage lifestyle (diet, physical activity).	Other: Education Participants in this group is provided education. Education includes information of metabolic syndrome, methods to manage lifestyle (diet, physical activity).
Experimental: Mobile Application (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.	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.
Experimental: Mobile Application (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.	Other: 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.

Arm

Intervention/Treatment

Other: No intervention (Education)

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

Other: Education

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

Experimental: Mobile Application (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.

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.

Experimental: Mobile Application (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.

Other: Mobile application for personal coaching

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei University College of Medicine	Seoul		Korea, Republic of	03722

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT03300271

Other Study ID Numbers:

4-2017-0666

First Posted:

Oct 3, 2017

Last Update Posted:

Jan 11, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Metabolic Syndrome

Insulin Resistance

Study Results

No Results Posted as of Jan 11, 2019