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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mobile application for self monitoring
Education
Mobile application for personal coaching
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome

Eligibility Criteria

30 Years - 59 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

No intervention (Education)

Mobile Application (Self monitoring)

Mobile Application (Personal coaching)

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
September 24, 2017
Last Updated
January 9, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03300271
Brief Title
Effects of a Supportive Mobile Health for Life Style Modification on Blood Pressure and Insulin Resistance Improvement in People With Metabolic Abnormalities
Official Title
Effects of a Supportive Mobile Health for Life Style Modification on Blood Pressure and Insulin Resistance Improvement in People With Metabolic Abnormalities
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 28, 2017 (Actual)
Primary Completion Date
August 2, 2018 (Actual)
Study Completion Date
August 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to either the experimental conditions (mobile application), or the usual condition (education).
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No intervention (Education)
Arm Type
Other
Arm Description
Participants in this group is provided education. Education includes information of metabolic syndrome, methods to manage lifestyle (diet, physical activity).
Arm Title
Mobile Application (Self monitoring)
Arm Type
Experimental
Arm 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.
Arm Title
Mobile Application (Personal coaching)
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Mobile application for self monitoring
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Participants in this group is provided education. Education includes information of metabolic syndrome, methods to manage lifestyle (diet, physical activity).
Intervention Type
Other
Intervention Name(s)
Mobile application for personal coaching
Intervention 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.
Primary Outcome Measure Information:
Title
Change in systolic/diastolic blood pressures
Description
Change of systolic/diastolic blood pressures and insulin resistance are the differences between the last visit and baseline (screening visit).
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in the eligibility criteria for metabolic syndrome
Description
Change of metabolic profiles are the differences between the last visit and baseline (screening visit).
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33034564
Citation
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.
Results Reference
derived

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

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