UMIN-CTR Clinical Trial

Basic information
Public title	Effects of a Mindfulness-Based Eating Awareness Training online intervention in adults of obesity: A randomized controlled trials
Acronym	Online Mindfulness-Based Eating Awareness Training for obesity.
Scientific Title	Effects of a Mindfulness-Based Eating Awareness Training online intervention in adults of obesity: A randomized controlled trials
Scientific Title:Acronym	Online Mindfulness-Based Eating Awareness Training for obesity.
Region	Japan

Condition
Condition	Obesity
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to examine the effectiveness of Mindfulness-Based Eating Awareness Training online intervention for obesity comparing Health Education group that receive health education information on the Internet by a randomized controlled trials
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Mean Change from Baseline of Hunger Score in TFEQ subscale (Time Frame: Baseline, 14visits and after 6 months (Self-Reported Questionnaire)
Key secondary outcomes	Mean Change from Baseline to 14 visits, and after 6 months (1) Body Mass Index (2)Weight loss rate (3)Three-Factor Eating Questionnaire(Total Score, Disinhibition subscale, Cognitive Restraint subscale) (4)Beck Depression Inventory (5)State-Trait Anxiety Inventory (6)Rosenberg Self-Esteem Scale (7)Barratt Impulsiveness Scale. (8)Positive and Negative Affect Schedule. (9)Binge Eating Scale. (10)Five Facet Mindfulness Questionnaire. (11)Mindfulness Attention Awareness Scale. (12)Self-Compassion Scale. (13)Exercise frequency(Meditation,Yoga,Number of steps) (14)Drug name of concomitant drug and daily dose. Mean Change from Baseline to 14 visits. (15)Serum protein(Leptin, Adiponectin, BDNF, Cortisol) Mean Change from Baseline to 6 months later. Changes in brain function and structure due to resting images, diffusion tensor images, and morphological brain images Secondary Outcome of Safety Adverse Events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Mindfulness-Based Eating Awareness Training/ 90min.per visit,14 weeks Follow-up
Interventions/Control_2	Health Education Email delivery once every two weeks,7 times Follow-up
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)Primary diagnosis of Obesity with a BMI of 30 or higher 2)The age between 18 to 65. 3)Patients with full consent of participation in the study. 4)Possible to communicate in Japanese. 5)Patients who have an internet environment at home and have a personal computer or tablet device. 6)No addition of weight loss drug or appetite suppressant during the study 7)Possible to understand Mindfulness-Based Eating Awareness Training and have mental and physical condition that can be participate the session for at least 6 months. 8)If Obesity is primary diagnosed, patients with Depressive Disorder and Anxiety Disorder will not be excluded from the study. 9)Patients who agree not to use weight loss drugs (Sanorex) for about 6 months until the end of the study. 10)Patients who agree not to undergo Bariatric surgery for about 6 months until the end of the study
Key exclusion criteria	1)Pregnant, lactating or less than 6 months after giving birth. 2)Patients who taking weight loss drugs or appetite suppressants. 3)Patients who plan undergo Bariatric surgery. 4)Patients who have Org anic brain disorder (including Dementia), Psychosis, Substance abuse or dependence, other severe mental disorders. 5)Active suicidality 6)Repetitive anti-social behavior 7)Severe physical condition 8)IQ under 80 by evaluating the JART25 (Japanese Adult Reading Test25) or IQ under 70 by Wechsler Adult Intelligence Scale. 9)Patients with Autism Spectrum Disorder. 10)Patients who cannot contact with the study organizer. 11)Other relevant reason decided by the investigato
Target sample size	32

Research contact person
Name of lead principal investigator	1st name Hiraku Middle name Last name Ono
Organization	Chiba University Hospital
Division name	Diabetes / Metabolism / Endocrinology
Zip code	260-8677
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL	0432227171
Email	hono@chiba-u.jp

Public contact
Name of contact person	1st name Junko Middle name Last name Matsumoto
Organization	Chiba University
Division name	Cognitive behavioral physiology
Zip code	260-8677
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL	0432262975
Homepage URL
Email	matsujun@chiba-u.jp

Sponsor
Institute	Chiba 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	Chiba University Hospital Certified Clinical Research Ethics Review Board
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan
Tel	0432227171
Email	prc-jim@chiba-u.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	2020 Year 10 Month 28 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 08 Month 15 Day
Date of IRB	2020 Year 06 Month 15 Day
Anticipated trial start date	2020 Year 10 Month 28 Day
Last follow-up date	2021 Year 10 Month 28 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 10 Month 27 Day
Last modified on	2020 Year 10 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048249