UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of relaxation (Autogenic Training) on weight reduction in obese/overweight male workers
Title of the study (Brief title)	Effect of relaxation on weight reduction in obese/overweight male workers
Region	Japan

Condition
Condition	obesity
Classification by specialty	Medicine in general Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of study is to examine the effect of relaxation on weight reduction in obese male workers.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Weight(weight reduction, weight regain)
Key secondary outcomes	Autonomic nervous system function. Blood Pressure(24hr-ABPM). Blood sample (obese-related hormones, metabolic markers, and inflammation markers). Self-recorded questionnaire (stress, psychological state and sleep state).

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	The subjects of intervention group are required to perform Autogenic Training (AT) procedure twice a day for three months. Meanwhile control group participants are waiting.
Interventions/Control_2	The subjects of both intervention and control groups lose weight through the three-month weight loss program supported by health fitness programmer, nuturitionist and medical doctor. Intervention group participants continue AT during the weight loss program.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	65 years-old >
Gender	Male
Key inclusion criteria	Workers. Overweight/obese people (BMI >= 25kg/m2).
Key exclusion criteria	Shift workers. People who are not naive to Autogenic Training. Patients who are not allowed to participate the study by their home doctors. Patients who start or change their medical treatments during the study.
Target sample size	50

Research contact person
Name of lead principal investigator	Fumio Kobayashi
Organization	Aichi Medical University School of Medicine
Division name	Department of Health and Psychosocial Medicine
Address	1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan
TEL	0561-62-3311(2312)
Email	fumio@aichi-med.u.ac.jp

Public contact
Name of contact person	Tomomi Hasegawa
Organization	Aichi Medical University School of Medicine
Division name	Department of Health and Psychosocial Medicine
Address	1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan
TEL	0561-62-3311(2312)
Homepage URL
Email	tommyh627@gmail.com

Sponsor
Institute	Department of Health and Psychosocial Medicine, Aichi Medical University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Grants-in-Aid for Scientific Research (25460820) from the Ministry of Education, Culture, Sports, Science and Technology of Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Institute of Physical Fitness, Sports Medicine and Rehabilitation, Aichi Medical University
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	愛知医科大学運動療育センター（愛知県） (Institute of Physical Fitness, Sports Medicine and Rehabilitation, Aichi Medical University, Aichi, Japan)

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 08 Month 30 Day
Anticipated trial start date	2011 Year 08 Month 30 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	2016 Year 06 Month 09 Day
Last modified on	2016 Year 06 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026128