UMIN-CTR Clinical Trial

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
Email	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
Email	tomomi.noda.smile@gmail.com

Sponsor
Institute	Kyoto University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046596