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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036107
Receipt No. R000041132
Scientific Title Effect of behavior change program for improvement of lifestyle habit on health and beauty images
Date of disclosure of the study information 2019/03/06
Last modified on 2019/06/19

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

Condition
Condition Overweight, obesity
Classification by specialty
Medicine in general Endocrinology and Metabolism Not applicable
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 1. Risk factor related to metabolic syndrome
2. Beauty images
Key secondary outcomes 1. Health Literacy
2. Health Competence
3. Sleep Quality
4. Physical Activity
5. Eating Behavior
6. Stress
7. Depression
8. Low Back Pain

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
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: 3-month of behavior change program and health education in 1 time per month (total 3 times).
Interventions/Control_2 Control group: health education in 1 time per 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

Not applicable
Gender Male and Female
Key inclusion criteria 1. City hall officials
2. Without regular exercise habits (Moderate-intensity exercise >= 2 day/week, or >= 150 min/week)
3. Without weight loss of diet and disease within the past 6 months
4. Did not intake supplements within 1 month
5. Without a patient receiving therapeutic agents for diabetes.
6. Did not participate in other clinical trials within 1 year
7. Agree with informed consent
Key exclusion criteria 1. Waist circumference was < 85 cm in men, < 90 cm in female, or < 25 kg/m2 of BMI
2. Pregnant or is planning to become pregnant
3. Medical history of neurological disorder of abdomen
4. Medical history of cerebrovascular disease and heart disease
5. Medication for fat metabolism and weight control
6. Medical history of orthopedic disease or operation within 1 year
7. Artificial joints or other type of metal objects in body
8. The sense of pressure of the abdomen
9. Chemical fiber allergy
Target sample size 60

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 036-8562
Address 5 Zaihu, Hirosaki, Aomori 036-8562 Japane
TEL 0172-39-5041
Email ihara@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name Songee
Middle name
Last name Jung
Organization Hirosaki University
Division name Graduate School of Medicine
Zip code 036-8562
Address 5 Zaihu, Hirosaki, Aomori 036-8562 Japane
TEL 0172-39-5041
Homepage URL
Email jonsoni@hirosaki-u.ac.jp

Sponsor
Institute Hirosaki University
Institute
Department

Funding Source
Organization MEXT(Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hirosaki University
Address 5 Zaihu, Hirosaki, Aomori 036-8562 Japane
Tel 0172-39-5041
Email hara@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 弘前大学(青森県)/Hirosaki University(Aomori)

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 06 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
2019 Year 02 Month 27 Day
Date of IRB
2019 Year 02 Month 22 Day
Anticipated trial start date
2019 Year 04 Month 22 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 06 Day
Last modified on
2019 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041132

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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