Tackle Obesity and Metabolic syndrome Outcome by Diet, Activities and Checking BW Intervention (RJ-TOMODACHI)
Not Applicable
- Conditions
- Men and women aged 25-60 years old with overweight/obesity (BMI 27-37 kg/m2)
- Registration Number
- JPRN-UMIN000033792
- Lead Sponsor
- Federal State Institution <National Medical Research Center for Preventive Medicine> of the Ministry of Healthcare of the Russian Federation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
1. Verified CAD. 2. AH of the 3 degree. 3. AVCC, TIA in history. 4. Chronic diseases in the acute stage, acute diseases. 5. Diseases requiring a special diet. 6. Type 1 and type 2 diabetes. 7. Oncological disease. 8. Chronic heart failure "II-IV", according to NYHA classification 9. Hyperthyroidism, hypothyroidism. 10. Mental diseases. 11. Disability groups for any disease. 12. Availability of medical electronic implants (pacemaker). 13. Bariatric surgery history. 14. Taking medications that can affect body weight changes (a 12). 15. Frequent business trips (more than 28 days in 6 months). 16. Night work/ daily work schedule
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effectiveness of a comprehensive program to reduce excess body weight (by 3-5%) with the inclusion of Japanese preventive technology of remote monitoring compared with dietary counseling.
- Secondary Outcome Measures
Name Time Method Physical examinations: measurement of blood pressure (BP), heart rate, anthropometric measurements such as height, weight, waist circumference, consultation with a therapist or cardiologist. Laboratory parameters in the blood and Urine: Complete blood count: Hemoglobin, Erythrocytes, Color index, Leukocytes, erythrocyte sedimentation rate. Urine analysis: Protein, Glucose, Ketones. Lipid profile: Total cholesterol, VLDL Cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides. Biochemical analysis of blood: Plasma glucose, fasting Glycated hemoglobin, Creatinine, Uric acid, Total protein, ALT, AST, TSH.