UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048205 |
|---|---|
| Receipt number | R000054913 |
| Scientific Title | An exploratory intervention study on the effects of health information on undernutrition among women in the workplace and its potential for social implementation |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2026/01/19 17:54:45 |
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Basic information
Public title
An intervention study on the effect of health information on women's health in the workplace
Acronym
An intervention study on the effect of health information on women's health in the workplace
Scientific Title
An exploratory intervention study on the effects of health information on undernutrition among women in the workplace and its potential for social implementation
Scientific Title:Acronym
An exploratory intervention study on the effects of health information on undernutrition among women in the workplace and its potential for social implementation
Region
| Japan |
Condition
Condition
Underweight
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct an exploratory study of the effectiveness and feasibility of providing health information to underweight women at the time of their workplace health examinations.
Basic objectives2
Others
Basic objectives -Others
To examine the costs and relevance of the intervention program, as well as the possibilities and challenges of social implementation
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Lifestyle attitudes and behaviors 3 months after intervention (using the Health Literacy Scale for Preconception short version)
Key secondary outcomes
Body image, presenteeism/absenteeism, quality of life, mental health
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Providing health information according to the participant's situation after beseline survey as an intervention group
Interventions/Control_2
Providing health information according to the participant's situation after endline survey as a control group
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
1. women between the ages of 20 and 60
2. women who had a regular health checkup at their workplace between September 2021 and March 2022
3. women whose BMI was less than 18.5 as a result of the medical checkup
4. women who are using a health portal site operated by the research contractor
Key exclusion criteria
1. BMI less than 16.0
2. weight loss of 10% or more from the previous year (only if the previous year's medical checkup data is available)
3. have been diagnosed with an eating disorder (ICD-10: F50) within the past 5 years (determined by the name of the disease on the receipt data)
4. diagnosed and treated for malignant tumor/cancer within the past 5 years (as determined by the ICD-10 C code on the receipt data)
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Takehara |
Organization
National Center for Child Health and Development
Division name
Department of Health Policy
Zip code
157-8535
Address
2-10-1 Okura, Setagaya, Tokyo
TEL
0334160181(ext.4250)
takehara-k@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Maeda |
Organization
National Center for Child Health and Development
Division name
Department of Health Policy
Zip code
157-8535
Address
2-10-1 Okura, Setagaya, Tokyo
TEL
0334160181(ext.4273)
Homepage URL
maeda-ak@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
National Center for Child Health and Development
Address
2-10-1 Okura, Setagaya, Tokyo
Tel
03-3416-0181(ext.5126)
rinri@ncchd.go.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
（株）JMDCが健診・レセプトデータを取り扱っている健康保険組合
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
https://www.mhlw.go.jp/content/10900000/001309249.pdf
Number of participants that the trial has enrolled
1921
Results
The primary and secondary outcome measures at baseline, including the lifestyle literacy scale scores, showed no significant differences between groups. Psychological distress (K6) at the one-month follow-up also showed no difference between groups. At the three-month follow-up, the proportion reporting "a gap appears" in the lower leg muscle mass (ring test) was significantly higher in the intervention group.
Results date posted
| 2026 | Year | 01 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age (SD: standard deviation) of the participants in this study was 44.6 (SD:9.5) years in the intervention group and 43.2 (SD:9.8) years in the control group. The BMI distribution (16.0 or higher but less than 17.0, 17.0 or higher but less than 18.0, 18.0 or higher but less than 18.5) was 19.9%, 45.2%, and 34.9% in the intervention group, and 22.3%, 44.5%, and 33.2% in the control group, showing no significant differences.
Participant flow
The 1,921 individuals who responded to the baseline survey were assigned to either the intervention group (1,008) or the control group (913). At the one-month follow-up, 788 individuals in the intervention group and 734 in the control group responded. At the three-month follow-up, 805 individuals (79.9%) from the intervention group and 681 individuals (74.6%) from the control group responded. Participants in the control group received the educational awareness tool and the intervention program after the three-month follow-up survey.
Adverse events
None
Outcome measures
Health Literacy Scale for preconception short version
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 30 | Day |
Last modified on
| 2026 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054913
