UMIN-CTR Clinical Trial

Basic information
Public title	Effect of behavior change program for improvement of lifestyle habits on health and beauty images
Acronym	Effect of behavior change program on health and beauty images
Scientific Title	Effect of behavior change program on health and beauty images
Scientific Title:Acronym	Effect of behavior change program on health and beauty images
Region	Japan

Condition
Condition	Metabolic syndrome
Classification by specialty	Medicine in general Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of behavior change program for improvement of lifestyle habits on health and beauty images
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	diagnosis for metabolic syndrome after 12-weeks of intervention
Key secondary outcomes	1. beauty images 2. body composition 3. eating behavior 4. health competence 5. health literacy 6. quality of sleep 7. physical activity 8. health knowledge 9. depression 10. poor circulation

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention group: behavior change program for 12 weeks and health education once a month (total 3 times)
Interventions/Control_2	Control group: health education once a month (total 3 times)
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	30 years-old <=
Age-upper limit	64 years-old >=
Gender	Male and Female
Key inclusion criteria	1. age between 20 years or older and 64 years or younger 2. with a BMI equal to or more than 25 or person who have been diagnosed with metabolic syndrome within past 1 year 3. agree to participation in the study
Key exclusion criteria	1. medication for diabetes, high blood pressure, and/or dyslipidemia 2. medical history of cerebral vascular disease or heart disease 3. weight loss of 5% of previous body weight in past 3 months 4. pregnant woman 5. experience of bad health by abdominal compression 6. allergy to chemical fiber 7. person who was judged by the investigator to be unsuitable for study participation 8. person who participated in another clinical trial within past 1 year
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kazushige Middle name Last name Ihara
Organization	Hirosaki University
Division name	Graduate School of Medicine
Zip code	0368562
Address	5 Zaifucho, Hirosaki, Aomori 0368562
TEL	0172395041
Email	ihara@hirosaki-u.ac.jp

Public contact
Name of contact person	1st name Hiroko Middle name Last name Matsubara
Organization	Hirosaki University
Division name	Graduate School of Medicine
Zip code	0368562
Address	5 Zaifucho, Hirosaki, Aomori 0368562
TEL	0172395041
Homepage URL
Email	matsubara@hirosaki-u.ac.jp

Sponsor
Institute	Hirosaki University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology (MEXT)
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	Hirosaki University
Address	5 Zaifucho, Hirosaki, Aomori
Tel	+81172395041
Email	ihara@hirosaki-u.ac.jp

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	2020 Year 08 Month 05 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	No longer recruiting
Date of protocol fixation	2020 Year 08 Month 05 Day
Date of IRB	2020 Year 08 Month 05 Day
Anticipated trial start date	2020 Year 08 Month 05 Day
Last follow-up date	2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	UMIN registration ID for pilot study: 000036107

Management information
Registered date	2020 Year 08 Month 05 Day
Last modified on	2020 Year 11 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047181