UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025568 |
|---|---|
| Receipt number | R000029424 |
| Scientific Title | The effective of mindfulness program for appetite regulation |
| Date of disclosure of the study information | 2017/01/17 |
| Last modified on | 2017/01/17 11:17:50 |
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Basic information
Public title
The effective of mindfulness program for appetite regulation
Acronym
Mindfulness for appetite regulation
Scientific Title
The effective of mindfulness program for appetite regulation
Scientific Title:Acronym
Mindfulness for appetite regulation
Region
| Japan |
Condition
Condition
obesity
Classification by specialty
| Endocrinology and Metabolism | Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of mindfulness meditation on appetite regulation and weight reduction in obese subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight, BMI, appetite(Baseline and 8 weeks after starting intervention)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Mindfulness mediation
group session: 1day(60 min) per week
8 weeks
Interventions/Control_2
Education on diet and exercise
providing information: 1 times per week
8 weeks
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Obesity: BMI>=25kg/m2
Healthy control: 18.5 kg/m2<BMI<=25 kg/m2
Key exclusion criteria
serious psychiatric/neurological/internal disease, experience of head trauma, taken any medication or supplement, pregnant women, those who have schedule of pregnancy, under any treatment for weight reduction, under meditation training
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin Fukudo |
Organization
Tohoku University
Division name
Department of Behavioral Medicine
Zip code
Address
2-1 Seiryo, Aoba-Ku, Sendai
TEL
022-717-8214
sfukudo@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiko Muratsubaki |
Organization
Tohoku University
Division name
Department of Behavioral Medicine
Zip code
Address
2-1 Seiryo, Aoba-Ku, Sendai
TEL
022-717-8162
Homepage URL
t-mura@med.tohoku.ac.jp
Sponsor or person
Institute
Department of Behavioral Medicine, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Young Scientists (B)
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
Address
Tel
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
| 2017 | Year | 01 | Month | 17 | 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
| 2016 | Year | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 06 | Day |
Last modified on
| 2017 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029424
