Metabolic Syndrome
Conditions
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.
Interventions
OTHERMobile 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.
OTHEREducation
Participants in this group is provided education. Education includes information of metabolic syndrome, methods to manage lifestyle (diet, physical activity).
OTHERMobile 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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
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.
Intervention model description
Participants will be randomly assigned to either the experimental conditions (mobile application), or the usual condition (education).
Eligibility
Sex/Gender
ALL
Age
30 Years to 59 Years
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: 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
South Korea
Outcome results
None listed