UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041846 |
|---|---|
| Receipt number | R000046596 |
| Scientific Title | Development of mindfulness-based program for prevention of anorexia nervosa |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2021/03/18 15:59:26 |
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Basic information
Public title
Development of mindfulness-based program for prevention of anorexia nervosa
Acronym
Mindfulness program for prevention of anorexia nervosa
Scientific Title
Development of mindfulness-based program for prevention of anorexia nervosa
Scientific Title:Acronym
Mindfulness program for prevention of anorexia nervosa
Region
| Japan |
Condition
Condition
anorexia nervosa
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop an emotional regulation improvement program with mindfulness-based meditation for healthy female who are aged 20-25 year old and underweight, and to examine its effect
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Head MRI images, and psychological tests related with eating behavior and emotion regulation function at the time point of pre and post intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Emotion regulation improvement program with mindfulness-based meditation
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy female aged 20 - 25 years old with BMI ranging from 14.2 - 17.6
Key exclusion criteria
Those who are diagnosed with or history of being diagnosed with psychiatric illnesses, those who have a neurological disorder, those who have a disease that affects the metabolism of the central nervous system, those who have a history of significant head injury, those who have cancer or those who have physical illnesses such as digestive system diseases, those who do not have sufficient consent ability due to intellectual disabilities, etc. In addition, the following individuals are excluded because MRI examination is difficult. Those who are pregnant, those who have metal medical devices embedded in their bodies, those who have implants in the oral cavity, those who have tattoos or permanent makeup, those who have claustrophobia.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | MASANORI |
| Middle name | |
| Last name | ISOBE |
Organization
Kyoto University, Graduate school of Medicine
Division name
Department of Psychiatry
Zip code
606-8507
Address
54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto
TEL
075-751-4947
masaniso@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | TOMOMI |
| Middle name | |
| Last name | NODA |
Organization
Kyoto University, Graduate school of Medicine
Division name
Department of Psychiatry
Zip code
606-8507
Address
54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto
TEL
075-751-4947
Homepage URL
tomomi.noda.smile@gmail.com
Sponsor or person
Institute
Kyoto 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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 01 | 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 | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2020 | Year | 09 | Month | 19 | Day |
Last modified on
| 2021 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046596
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
