UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053744 |
|---|---|
| Receipt number | R000061333 |
| Scientific Title | Development of an ICT-based breastfeeding support program during pregnancy and verification of its effectiveness |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2025/03/02 10:30:57 |
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Basic information
Public title
Development of an ICT-based breastfeeding support program during pregnancy and verification of its effectiveness
Acronym
Development of an ICT-based breastfeeding support program during pregnancy and verification of its effectiveness
Scientific Title
Development of an ICT-based breastfeeding support program during pregnancy and verification of its effectiveness
Scientific Title:Acronym
Development of an ICT-based breastfeeding support program during pregnancy and verification of its effectiveness
Region
| Japan |
Condition
Condition
Healthy pregnant woman
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop and verify the effectiveness of an ICT-based breastfeeding support program during pregnancy to help women who wish to breastfeed increase their sense of self-efficacy, make breastfeeding decisions, and continue breastfeeding.
This program is expected to increase the self-efficacy of women who wish to breastfeed during pregnancy, enable them to make breastfeeding decisions, reduce the sense of lack of breast milk and the burden of breastfeeding after delivery, and reduce the risk of early discontinuation of breastfeeding.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measuring the effectiveness of the intervention by desire to breastfeed in the last trimester of pregnancy and breastfeeding rate within 3 months postpartum
Key secondary outcomes
1) Program utilization status and breastfeeding desire during the last trimester of pregnancy, and evaluation using the Japanese version of the Breastfeeding Self-Efficacy Scale
(2) Within 3 months postpartum, program usage and breastfeeding status from pregnancy to now, and evaluation using the Japanese version of the Breastfeeding Self-Efficacy Scale and the Japanese version of the Breastfeeding Insufficiency Scale.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The program consists of educational materials distributed through social networking sites and, if desired, online individual counseling related to the educational materials with midwives who specialize in breastfeeding (30 minutes per meeting, free of charge and unlimited number of times upon application).
The course materials are 9 courses, based on The Ten Steps to Successful Breastfeeding (WHO, 2018), based on medical evidence, and supervised by experts in breastfeeding support The course time per material is about 5 to 10 minutes, and can be taken with a smartphone or tablet device. There is no limit to the time required to take the course, and it can be viewed by scrolling through the screen on a smartphone or tablet device.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Pregnant women aged 20 years or older (regardless of the number of births or breastfeeding history) who have undergone antenatal checkups at cooperating facilities and have a good pregnancy progress from 24 to 32 weeks gestation.
Key exclusion criteria
If it is known that the mother will not breastfeed after delivery for medical reasons, etc.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Chiharu |
| Middle name | |
| Last name | INADA |
Organization
Japanese Red Cross College of Nursing
Division name
Graduate School of Nursing Global Health Care and Midwifery
Zip code
150-0012
Address
4-1-3 Hiroo Shibuya-ku Tokyo
TEL
03-3409-0839
c-inada@redcross.ac.jp
Public contact
Name of contact person
| 1st name | Chiharu |
| Middle name | |
| Last name | INADA |
Organization
Japanese Red Cross College of Nursing
Division name
Graduate School of Nursing Global Health Care and Midwifery
Zip code
150-0012
Address
4-1-3 Hiroo Shibuya-ku Tokyo
TEL
03-3409-0839
Homepage URL
soumu@redcross.ac.jp
Sponsor or person
Institute
Japanese Red Cross College of Nursing
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Japanese Red Cross of Nursing
Address
4-1-3 Hiroo Shibuya-ku Tokyo
Tel
03-3409-0875
soumu@redcross.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
日本赤十字社医療センター（東京都）
つくばセントラル病院（茨城県）
国立成育医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 01 | 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
| 2024 | Year | 02 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 04 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 01 | Day |
Last modified on
| 2025 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061333
