UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039896 |
|---|---|
| Receipt number | R000045502 |
| Scientific Title | Remote Monitoring of Body Weight - RJ-Region multicenter Russian-Japanese project |
| Date of disclosure of the study information | 2021/05/24 |
| Last modified on | 2021/05/25 21:14:34 |
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Basic information
Public title
Remote Monitoring of Body Weight - RJ-Region
multicenter Russian-Japanese project
Acronym
RJ-Region Project
Scientific Title
Remote Monitoring of Body Weight - RJ-Region
multicenter Russian-Japanese project
Scientific Title:Acronym
RJ-Region Project
Region
| Europe |
Condition
Condition
Men and women aged 18 -60 years old with overweight/obesity (BMI 27-37 kg/m2(inclusive).
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of Japanese preventive technology adapted to domestic health conditionsand aimed at reducing overweight and obesity based on personalized preventive counseling and remote control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Reducing overweight and obesity(by 3-5 %)from baseline body mass during 3-6 month follow up
Key secondary outcomes
waist circumference (cm), body mass index (kg/m2), blood pressure level (mm Hg)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
High Intensity intervention
1) Using self-monitoring devices (scales, blood pressure monitor, fitness-tracker)
2) Weekly monitoring and support (by mobile applicationandduring 2 interim visits): The analysis of the participants`remotely transmitted data, nutrition diary, blood pressure level, weight and dataphysical activity leve. Support / behavior correction, taking into account the acquired data on nutrition, self-monitoring devices
Interventions/Control_2
Low intensity intervention
1) Using self-monitoring devices (scales, blood pressure monitor, fitness-tracker)
2) Weekly monitoring and support (by mobile application only): The analysis of the participants`remotely transmitted data: nutrition diary, blood pressure level, weight and physical activity level.Support / behavior correction, taking into account the acquired data on nutrition, self-monitoring
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Men and women aged 18 -60 years old with overweight/obesity (BMI 27-37 kg/m2).
Signedinformed consent.
Internet access and a personal smartphone with Android operating system version 4.0 and higher.
Signed documents on acceptance and obligation to return all handed devices at the end of the project.
Key exclusion criteria
Verified CAD.
AH of the 3 degree.
AVCC, TIA in history.
Type 1 and type 2 diabetes.
Oncological disease.
Chronic heart failure III-IV functional class, according to NYHA classification
Hyperthyroidism, hypothyroidism.
Mental diseases.
Chronic alcoholism
Implanted medical electronic devices(pacemaker).
Bariatric surgery history.
Taking medications that can affect body weight changes.
Pregnancy
Frequent or long-term business trips/vacations during the planned period of follow-up.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Anna |
| Middle name | V |
| Last name | Kontsevaya |
Organization
Federal State Institution National Medical Research Center for Terapy and Preventive Medicine
Division name
Department of Primary Prevention of Chronic Non-Communicable Diseases in the Healthcare System
Zip code
101990
Address
Petroverigskii per., 10, Moscow, Russia
TEL
+7(495)7907177
AKontsevaya@gnicpm.ru
Public contact
Name of contact person
| 1st name | Boris |
| Middle name | E |
| Last name | Gornyy |
Organization
Federal State Institution National Medical Research Center for Terapy and Preventive Medicine
Division name
Department of Primary Prevention of Chronic Non-Communicable Diseases in the Healthcare System
Zip code
101990
Address
Petroverigskii per., 10, Moscow, Russia
TEL
+7(495)7907177
Homepage URL
http://www.gnicpm.ru
bgornyy@gnicpm.ru
Sponsor or person
Institute
Federal State Institution National Medical Research Center for Terapy and Preventive Medicine
Institute
Department
Personal name
Funding Source
Organization
Federal State Institution National Medical Research Center for Terapy and Preventive Medicine
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Russia
Other related organizations
Co-sponsor
Comprehensive Health Science Center, Aichi Health Promotion Public Interest Foundation
ShigaUniversityofMedicalScience
National Cerebral and Cardiovascular Center
Name of secondary funder(s)
MHLW(Japan)
IRB Contact (For public release)
Organization
Federal State Institution National Medical Research Center for Terapy and Preventive Medicine
Address
Petroverigskii per., 10, Moscow, Russia
Tel
+7(499)553-67-77
AKontsevaya@gnicpm.ru
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Health Center of the Medical Prevention Center(Orenburg Region);
College of Medicine + Offices of general medical practice (Sverdlovsk Region);
Department for medical prevention of City Clinic (Tyumen Region);
Central Clinical Medical Unit + Health Center of the Medical Prevention Center + Regional Clinical Hospital (Ulyanovsk Region);
Medical Prevention Center(Yamal-Nenets Autonomous District);
Clinic of Tver State Medical University + Medical Prevention Center(Tver Region).
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2020 | Year | 03 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 21 | Day |
Last modified on
| 2021 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045502
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