UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036107 |
|---|---|
| Receipt number | 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 | 2020/11/05 15:17:20 |
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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
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
036-8562
Address
5 Zaihu, Hirosaki, Aomori 036-8562 Japane
TEL
0172-39-5041
Homepage URL
matsubara@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University
Institute
Department
Personal name
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
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
| 2020 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2022 | 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
| 2020 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041132
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
