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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025987
Receipt No. R000029868
Scientific Title Effect of laughter for prevention of development or exacerbation of lifestyle diseases: Intervention study
Date of disclosure of the study information 2017/03/31
Last modified on 2017/02/03

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Basic information
Public title Effect of laughter for prevention of development or exacerbation of lifestyle diseases: Intervention study
Acronym Effect of laughter for prevention of lifestyle diseases: randomized controlled trial
Scientific Title Effect of laughter for prevention of development or exacerbation of lifestyle diseases: Intervention study
Scientific Title:Acronym Effect of laughter for prevention of lifestyle diseases: randomized controlled trial
Region
Japan

Condition
Condition Lifestyle disease (metabolic syndrome, diabetes mellitus, hypertension)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of laughter on HbA1c, blood pressure, and stress markers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HbA1c (rapid determination)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Same intervention program is conducted on 0-3 month for early intervention group and 4-6 month for later intervention group. Intervention program is 90 minutes each, once a week, 10 times and the contents are as follows.
1. Small lecture about laughter and health and diabetes
2. Increasing the chance of laughter in the program of Laughter yoga and sit-down comedy
3. Increasing the chance of laughter trough communication with other participants in the program
4. Increasing the chance of laughter through introducing the event, movie, books regarding laughter.
*Laughter yoga is the combination health management methods of laughter as an exercise and breathing of yoga. People are able to experience laughter without laughable emotion. We applied laughter yoga since it is easy to practice for public.

Interventions/Control_2 Participants live as usual for another half of the research period.
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
40 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1. Those who live around Okayama city and able to participate in the program
2. Those who have metabolic syndrome or suspicious to have it.
3. Those who are able to do light physical activity
4. Those who understand and consent with participation to the study after the enough explanation of the study purpose and contents.
Key exclusion criteria Those who have history of stroke or coronary heart disease (They are able to participate if primary doctor allow the participation)
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eri Eguchi
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Public health
Zip code
Address Shikata cho 2-5-1
TEL 086-235-7184
Email eri_eguchi@okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eri Eguchi
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Public health
Zip code
Address Shikata cho 2-5-1
TEL 086-235-7184
Homepage URL
Email eri_eguchi@okayama-u.ac.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development : AMED
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
Email

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 03 Month 31 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 Open public recruiting
Date of protocol fixation
2017 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 04 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 02 Month 03 Day
Last modified on
2017 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029868

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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