UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045818 |
|---|---|
| Receipt number | R000052075 |
| Scientific Title | Mindfulness Eating for Raising Fitness and Control: randomized control trial |
| Date of disclosure of the study information | 2021/10/21 |
| Last modified on | 2024/04/23 13:37:34 |
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Basic information
Public title
Mindfulness Eating for Raising Fitness and Control: randomized control trial
Acronym
MERCI-RCT
Scientific Title
Mindfulness Eating for Raising Fitness and Control: randomized control trial
Scientific Title:Acronym
MERCI-RCT
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Medicine in general | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the effectiveness of online mindfulness-based group program for weight reduction among workers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean change of body weight (from baseline to 3 and 6 months)
Key secondary outcomes
Mean Change from Baseline to 4 visits and after 3 and 6 months
1:Five Facet Mindfulness Questionnaire
2:EuroQoL-5Dimension-5L
3: Dutch Eating Behavior Questionnaire
4:K6
5:Periodic Health Examination Questionnaire Items
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Counseling
Mindfulness Eating for Raising Fitness and Control
60min.per visit,4 session (8 weeks)
Follow-up
Interventions/Control_2
waiting group
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Those who have undergone a regular medical checkup during the year of participation in the test
2. Those who are expected to participate in the program at least three times
3. Those who are willing to administer each questionnaire (baseline , after 3 months, and after 6 months)
4. Those who submitted written informed consent
Key exclusion criteria
1. Those who are judged by the principal investigator to have difficulty in understanding the contents of this program and interacting with other participants due to some kind of physical, mental, or cognitive disability
2. Those who clearly have difficulty in attending the program four times every other week and following up for one month.
3:Other relevant reason decided by the investigato
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Yamaichi |
Organization
Keio University School of Medicine,
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
Tokyo shinjyuku shinanomachi 35
TEL
03-3353-1211
ichidai@keio.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Yamaichi |
Organization
Keio University School of Medicine,
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
Tokyo shinjyuku shinanomachi 35
TEL
03-3353-1211
Homepage URL
ichidai@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine, Ethics Committee
Address
35 Shinanomachi, Shinjuku, Tokyo, JAPAN
Tel
03-5363-3638
med-rinri-jimu@adst.keio.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 21 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 21 | Day |
Last modified on
| 2024 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052075
