UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effective of mindfulness program for appetite regulation
Title of the study (Brief title)	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	Shin Fukudo
Organization	Tohoku University
Division name	Department of Behavioral Medicine
Address	2-1 Seiryo, Aoba-Ku, Sendai
TEL	022-717-8214
Email	sfukudo@med.tohoku.ac.jp

Public contact
Name of contact person	Tomohiko Muratsubaki
Organization	Tohoku University
Division name	Department of Behavioral Medicine
Address	2-1 Seiryo, Aoba-Ku, Sendai
TEL	022-717-8162
Homepage URL
Email	t-mura@med.tohoku.ac.jp

Sponsor
Institute	Department of Behavioral Medicine, Tohoku University
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 12 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029424