UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042260 |
|---|---|
| Receipt number | R000048249 |
| Scientific Title | Effects of a Mindfulness-Based Eating Awareness Training online intervention in adults of obesity: A randomized controlled trials |
| Date of disclosure of the study information | 2020/10/28 |
| Last modified on | 2020/10/27 18:38:17 |
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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
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
matsujun@chiba-u.jp
Sponsor or person
Institute
Chiba 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
Chiba University Hospital Certified Clinical Research Ethics Review Board
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
Tel
0432227171
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048249
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| Registered date | File name |
| Research case data | |
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