UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041327 |
|---|---|
| Receipt number | 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 | 2020/11/05 15:20:05 |
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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
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
matsubara@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047181
| Research Plan | |
|---|---|
| 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 |
