Effects of a Supportive Mobile Health for Life Style Modification on Blood Pressure and Insulin Resistance Improvement in People With Metabolic Abnormalities
1 other identifier
interventional
129
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2017
CompletedFirst Posted
Study publicly available on registry
October 3, 2017
CompletedStudy Start
First participant enrolled
October 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 2, 2018
CompletedJanuary 11, 2019
January 1, 2019
9 months
September 24, 2017
January 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change in the eligibility criteria for metabolic syndrome
24 weeks
Study Arms (3)
No intervention (Education)
OTHERParticipants in this group is provided education. Education includes information of metabolic syndrome, methods to manage lifestyle (diet, physical activity).
Mobile Application (Self monitoring)
EXPERIMENTALParticipants 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)
EXPERIMENTALParticipants 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
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 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. 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.
Eligibility Criteria
You may qualify if:
- "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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yonsei University College of Medicine
Seoul, 03722, South Korea
Related Publications (1)
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.
PMID: 33034564DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2017
First Posted
October 3, 2017
Study Start
October 28, 2017
Primary Completion
August 2, 2018
Study Completion
August 2, 2018
Last Updated
January 11, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share