UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022675 |
|---|---|
| Receipt number | R000026128 |
| Scientific Title | Effect of relaxation (Autogenic Training) on weight reduction in obese/overweight male workers |
| Date of disclosure of the study information | 2016/06/10 |
| Last modified on | 2016/06/09 09:38:26 |
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Basic information
Public title
Effect of relaxation (Autogenic Training) on weight reduction in obese/overweight male workers
Acronym
Effect of relaxation on weight reduction in obese/overweight male workers
Scientific Title
Effect of relaxation (Autogenic Training) on weight reduction in obese/overweight male workers
Scientific Title:Acronym
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).
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
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
| 1st name | |
| Middle name | |
| Last name | Fumio Kobayashi |
Organization
Aichi Medical University School of Medicine
Division name
Department of Health and Psychosocial Medicine
Zip code
Address
1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan
TEL
0561-62-3311(2312)
fumio@aichi-med.u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomomi Hasegawa |
Organization
Aichi Medical University School of Medicine
Division name
Department of Health and Psychosocial Medicine
Zip code
Address
1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan
TEL
0561-62-3311(2312)
Homepage URL
tommyh627@gmail.com
Sponsor or person
Institute
Department of Health and Psychosocial Medicine, Aichi Medical University School of Medicine
Institute
Department
Personal name
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)
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
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 |
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
Completed
Date of protocol fixation
| 2011 | Year | 08 | Month | 30 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026128
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
