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Tackle Obesity and Metabolic syndrome Outcome by Diet, Activities and Checking BW Intervention (RJ-TOMODACHI)

Tackle Obesity and Metabolic syndrome Outcome by Diet, Activities and Checking BW Intervention (RJ-TOMODACHI) - RJ-TOMODACHI Project

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000033792
Enrollment
200
Registered
2018-08-18
Start date
2018-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Men and women aged 25-60 years old with overweight/obesity (BMI 27-37 kg/m2)

Interventions

High Intensity intervention 1)Using self-monitoring devices (scales, blood pressure monitor, fitness-tracker) 2)Weekly monitoring and support (by phone, at visit, by e-mail, by messenger): The analy

Sponsors

Federal State Institution <National Medical Research Center for Preventive Medicine> of the Ministry of Healthcare of the Russian Federation
Lead Sponsor
Comprehensive Health Science Center, Aichi Health Promotion Public Interest Foundation Shiga University of Medical Science National Cerebral and Cardiovascular Center
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Men and women aged 25-60 years old with overweight/obesity (BMI 27-37 kg/m2). 2. Accommodation in Moscow and Moscow region. 3. Signing of informed consent. 4. Availability of Internet access (use of e-mail). 5. Use of mobile (cellular) communication.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Europe

Contacts

Public ContactYulia Balanova

<National Medical Research Center for Preventive Medicine> of the Ministry of Healthcare (Russia) Department of Epidemiology of Chronic Non-Communicable Diseases

JBalanova@gnicpm.ru+7(495)7907172

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026