Metabolic SyndromeNCT03300271
Effects of a Supportive Mobile Health for Life Style Modification on Blood Pressure and Insulin Resistance Improvement in People With Metabolic Abnormalities
A study testing Mobile application for self monitoring, Education and Mobile application for personal coaching in people with Metabolic Syndrome, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 30 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Mobile application for self monitoring, Education and Mobile application for personal coaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Oct 2017to 2 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- "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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Mobile application for self monitoring, Education, Mobile application for personal coaching
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile application for self monitoringOther
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.
EducationOther
Participants in this group is provided education. Education includes information of metabolic syndrome, methods to manage lifestyle (diet, physical activity).
Mobile application for personal coachingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| No intervention (Education) | Other | Participants in this group is provided education. Education includes information of metabolic syndrome, methods to manage lifestyle (diet, physical activity). Receives: Other: Education |
| Mobile Application (Self monitoring) | Experimental | 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. Receives: Other: Mobile application for self monitoring |
| Mobile Application (Personal coaching) | Experimental | 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. Receives: Other: Mobile application for personal coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 weeks
Secondary outcomes (1)
Change in the eligibility criteria for metabolic syndrome
Change of metabolic profiles are the differences between the last visit and baseline (screening visit).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start28 Oct 2017
- Primary completion2 Aug 2018
- Study completion2 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the experimental conditions (mobile application), or the usual condition (education).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300271
- Sponsor's protocol ID
- 4-2017-0666
- Status last verified
- Jan 2019
- First submitted
- 24 Sep 2017
- Last updated
- 11 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33034564
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Supportive Mobile Health for Life Style Modification on Blood Pressure and Insulin Resistance Improvement in People With Metabolic Abnormalities
- ClinicalTrials.gov ID
- NCT03300271
- Acronym / sponsor ID
- 4-2017-0666
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 28 Oct 2017 (actual)
- Primary completion
- 2 Aug 2018 (actual)
- Study completion
- 2 Aug 2018 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to either the experimental conditions (mobile application), or the usual condition (education).
| Arm | Type | Receives |
|---|---|---|
| No intervention (Education) | Other | Other: EducationParticipants in this group is provided education. Education includes information of metabolic syndrome, methods to manage lifestyle (diet, physical activity). |
| Mobile Application (Self monitoring) | Experimental | Other: Mobile application for self monitoringParticipants 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) | Experimental | Other: Mobile application for personal coachingParticipants 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. |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- "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:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile application for self monitoringParticipants 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 (Self monitoring) |
| EducationParticipants in this group is provided education. Education includes information of metabolic syndrome, methods to manage lifestyle (diet, physical activity). | Other | No intervention (Education) |
| Mobile application for personal coachingParticipants 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 (Personal coaching) |
Primary outcome
Change in systolic/diastolic blood pressures
Time frame: 24 weeks
Change of systolic/diastolic blood pressures and insulin resistance are the differences between the last visit and baseline (screening visit).
1 secondary outcome
Change in the eligibility criteria for metabolic syndrome
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Derived from this study: PubMed 33034564Cho 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application for self monitoring, Education and Mobile application for personal coaching in people with Metabolic Syndrome, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic/diastolic blood pressures (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03300271, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.