UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of laughter for prevention of development or exacerbation of lifestyle diseases: Intervention study
Title of the study (Brief title)	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	Eri Eguchi
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Public health
Address	Shikata cho 2-5-1
TEL	086-235-7184
Email	eri_eguchi@okayama-u.ac.jp

Public contact
Name of contact person	Eri Eguchi
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Public health
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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