UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052936 |
|---|---|
| Receipt number | R000060399 |
| Scientific Title | Effects of Health Education on Lifestyle and Bone Density in Postmenopausal Women |
| Date of disclosure of the study information | 2023/11/28 |
| Last modified on | 2023/11/28 21:16:20 |
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Basic information
Public title
Effects of Health Education on Lifestyle and Bone Density in Postmenopausal Women
Acronym
Effects of Health Education on Lifestyle and Bone Density in Postmenopausal Women
Scientific Title
Effects of Health Education on Lifestyle and Bone Density in Postmenopausal Women
Scientific Title:Acronym
Effects of Health Education on Lifestyle and Bone Density in Postmenopausal Women
Region
| Japan |
Condition
Condition
Postmenopausal women
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether an active learning health education intervention for postmenopausal women will result in lifestyle changes and improved bone mineral density.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Calcium intake 6 months after health education intervention
Key secondary outcomes
Vitamin K intake, vitamin D intake, physical activity in leisure time, physical activity at home, physical activity at work, physical activity on the move, and self-efficacy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Two active learning health education sessions over a six-month period.
Interventions/Control_2
Distribution of pamphlets summarizing health education content
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Women over 60 years old
Key exclusion criteria
Women with a Mini-COG score of 2 or less
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | |
| Last name | Nagahashi |
Organization
Nagasaki University
Division name
Institute of Biomedical Sciences
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197950
miyuki-a@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Nagahashi |
Organization
Nagasaki University
Division name
Institute of Biomedical Sciences
Zip code
8528520
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197950
Homepage URL
miyuki-a@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University
Address
1-12-4 Sakamoto, Nagasaki
Tel
0958197198
gakujutu_gakuji@ml.nagasaki-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
| 2023 | Year | 11 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 07 | 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
| 2023 | Year | 11 | Month | 28 | Day |
Last modified on
| 2023 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060399
| 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 |
