UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053377 |
|---|---|
| Receipt number | R000059072 |
| Scientific Title | Development and evaluation of a support program based on mothers' information needs regarding breastfeeding continuation or termination: to reduce mothers' decisional conflict |
| Date of disclosure of the study information | 2024/01/17 |
| Last modified on | 2025/02/17 15:55:21 |
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Basic information
Public title
Development and evaluation of a support program based on mothers' information needs regarding breastfeeding continuation or termination: to reduce mothers' decisional conflict
Acronym
Development and evaluation of a support program based on mothers' information needs regarding breastfeeding continuation or termination: to reduce mothers' decisional conflict
Scientific Title
Development and evaluation of a support program based on mothers' information needs regarding breastfeeding continuation or termination: to reduce mothers' decisional conflict
Scientific Title:Acronym
Development and evaluation of a support program based on mothers' information needs regarding breastfeeding continuation or termination
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a support program based on mothers' information needs regarding continuation or termination of breastfeeding.
In addition, to evaluate a support program to reduce mothers' decisional conflict regarding continuation or termination of breastfeeding through a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Decisional conflict regarding continuation or termination of breastfeeding
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Other |
Interventions/Control_1
A support program based on mothers' information needs regarding continuation or termination of breastfeeding will be implemented for breastfeeding mothers after 6 months postpartum.
The support program will provide information according to a booklet that summarizes information on continuation and termination of breastfeeding. The support program will be conducted in an online format using the Zoom web conferencing system, and will be conducted once for about one hour.
Interventions/Control_2
The control group will not receive the support program, but will receive a booklet with information on continuation and termination during breastfeeding after all surveys are completed. In addition, after all surveys are completed, those who wish to participate will be offered the same program as the intervention 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
| Not applicable |
Gender
Female
Key inclusion criteria
Those who are breastfeeding at the time of recruitment
Those who are 6 months postpartum or later
Those who are breastfeeding a single child (not twins, triplets, etc.)
Those who have decisional conflicts regarding continuation or termination of breastfeeding and wish to participate in this program
Those who are able to communicate in Japanese
Those who are able to use the Zoom web conferencing system
Key exclusion criteria
Those who plan to terminate breastfeeding for medical reasons, such as medical treatment of the mother or child
Those who are received breastfeeding support from a professional regarding continuation or termination of breastfeeding at the time of recruitment
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | MORIMOTO |
Organization
Osaka Metropolitan University
Division name
Graduate School of Nursing Department of Nursing, School of Nursing Department of Nursing
Zip code
583-8555
Address
3-7-30 Habikino, Habikino-city, Osaka, Japan.
TEL
072-950-2902
morimoto@omu.ac.jp
Public contact
Name of contact person
| 1st name | Risako |
| Middle name | |
| Last name | HAYASHI |
Organization
Osaka Prefecture University
Division name
Graduate School of Nursing Department of Nursing
Zip code
583-8555
Address
3-7-30 Habikino, Habikino-city, Osaka, Japan.
TEL
072-950-2111
Homepage URL
de601003@st.osakafu-u.ac.jp
Sponsor or person
Institute
Osaka Prefecture University
Institute
Department
Personal name
Funding Source
Organization
Osaka Metropolitan 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
Osaka Prefecture University Graduate School of Nursing Institutional Review Board
Address
3-7-30 Habikino, Habikino-city, Osaka 583-8555, Japan
Tel
072-950-2111
gr-hab-rinri@omu.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
| 2024 | Year | 01 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 17 | Day |
Last modified on
| 2025 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059072
