UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060651 |
|---|---|
| Receipt number | R000069368 |
| Scientific Title | Development of a Self-Care Enhancement Program through the "Health Lab for Women of Child-Rearing Age" Utilizing On-Campus Practical Training Stations |
| Date of disclosure of the study information | 2026/02/12 |
| Last modified on | 2026/02/12 07:05:07 |
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Basic information
Public title
Development of a Self-Care Enhancement Program Using the Health Lab for Women in the Child-Rearing Generation
Acronym
CARE-LAB Study
Scientific Title
Development of a Self-Care Enhancement Program through the "Health Lab for Women of Child-Rearing Age" Utilizing On-Campus Practical Training Stations
Scientific Title:Acronym
CARE-LAB Study
Region
| Japan |
Condition
Condition
Women under 45 years of age raising children
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine and pilot a "Health Lab" program that provides parenting women with opportunities and environments to learn about physical, psychological, and lifestyle-related health to promote self-care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective Well-Being Inventory (SUBI) At 2 months post-program
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The Health Lab-based self-care enhancement program will be conducted in two sessions held one week apart.
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
Women aged under 45 years with a firstborn child who has not yet entered elementary school
Key exclusion criteria
Inability to visit Kanagawa University of Human Services in person
Inability to participate in the two-day program
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ryoko |
| Middle name | |
| Last name | Higuchi |
Organization
Kanabawa University of Human Services
Division name
Faculty of Health & Social Services School of Nutrition & Dietetics
Zip code
2388522
Address
1-10-1 Heiseicho,Yokosuka ,Kanagawa,Japan
TEL
0468282652
higuchi-nk3@kuhs.ac.jp
Public contact
Name of contact person
| 1st name | Ryoko |
| Middle name | |
| Last name | Higuchi |
Organization
Kanabawa University of Human Services
Division name
Faculty of Health & Social Services School of Nutrition & Dietetics
Zip code
2388522
Address
1-10-1 Heiseicho,Yokosuka ,Kanagawa,Japan
TEL
0468282652
Homepage URL
higuchi-nk3@kuhs.ac.jp
Sponsor or person
Institute
Kanabawa University of Human Services
Institute
Department
Personal name
Funding Source
Organization
Kanabawa University of Human Services
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
Kanabawa University of Human Services
Address
1-10-1 Heiseicho,Yokosuka ,Kanagawa,Japan
Tel
0468282652
higuchi-nk3@kuhs.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
| 2026 | Year | 02 | Month | 12 | 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
| 2026 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 02 | Month | 12 | Day |
Last modified on
| 2026 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069368
