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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041327
Receipt No. R000047181
Scientific Title Effect of behavior change program on health and beauty images
Date of disclosure of the study information 2020/08/05
Last modified on 2020/08/05

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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 Open public 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 08 Month 05 Day


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

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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