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

NCT ID: NCT03300271

Last Updated: 2019-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-28

Study Completion Date

2018-08-02

Brief Summary

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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

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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.

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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No intervention (Education)

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

Group Type OTHER

Education

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Mobile application for self monitoring

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Mobile application for personal coaching

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Education

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Cho SMJ, Lee JH, Shim JS, Yeom H, Lee SJ, Jeon YW, Kim HC. Effect of Smartphone-Based Lifestyle Coaching App on Community-Dwelling Population With Moderate Metabolic Abnormalities: Randomized Controlled Trial. J Med Internet Res. 2020 Oct 9;22(10):e17435. doi: 10.2196/17435.

Reference Type DERIVED
PMID: 33034564 (View on PubMed)

Other Identifiers

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4-2017-0666

Identifier Type: -

Identifier Source: org_study_id

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