Clinical trial NCT03300271: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 129
Sex: ALL
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either the experimental conditions (mobile application), or the usual condition (education).
Primary purpose: PREVENTION

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.

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:

  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

Primary outcomes:
measure: Change in systolic/diastolic blood pressures
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in the eligibility criteria for metabolic syndrome
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
References:
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.