UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023322 |
|---|---|
| Receipt number | R000026869 |
| Scientific Title | Benefits of breastfeeding vs Risks of formula To improve nurses' attitudes towards breastfeeding |
| Date of disclosure of the study information | 2016/08/05 |
| Last modified on | 2023/05/11 17:26:53 |
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Basic information
Public title
Benefits of breastfeeding vs Risks of formula
To improve nurses' attitudes towards breastfeeding
Acronym
Nurses' attitudes towards breastfeeding in Japan
Scientific Title
Benefits of breastfeeding vs Risks of formula
To improve nurses' attitudes towards breastfeeding
Scientific Title:Acronym
Nurses' attitudes towards breastfeeding in Japan
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Obstetrics and Gynecology | Pediatrics | Nursing |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of benefits of breastfeeding and risks of formula messages on breastfeeding attitudes among Japanese nurses.
Basic objectives2
Others
Basic objectives -Others
To examine the association between the impression of the intervention and nurses attitudes towards breastfeeding.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Japanese version of the Iowa Infant Feeding Attitude Scale
Key secondary outcomes
Socio-demographic characteristics
Questions about impressions towards the interventions in the post-test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Benefits of breastfeeding was developed by Wallace and Taylor in 2011 for their research. Prior to revising the messages, we checked WHO and American Academics of Pediatrics statements and the latest systematic reviews for the latest findings. After we translated the messages into Japanese, we back-translated them into English. Through this process, we ensured that the messages were comprehensible and the meanings had not been changed. Then to confirm relevance of them, advice from a pediatrician with breastfeeding and formula-feeding knowledge was obtained. Further feedback from another researcher who have breastfeeding and formula-feeding knowledge was also sought. Finally, I obtained permission to use the messages from the authors.
Benefits of breastfeeding mentions health and developmental benefits of breastfeeding for infants and children. Japanese version consists of 775 letters.
Participants will be required to read intervention and to complete a questionnaire online, which will take about 30 minutes.
Interventions/Control_2
Risks of formula-feeding was developed by Wallace and Taylor in 2011 for their research. Prior to revising the messages, we checked WHO and American Academics of Pediatrics statements and the latest systematic reviews for the latest findings. After we translated the messages into Japanese, we back-translated them into English. Through this process, we ensured that the messages were comprehensible and the meanings had not been changed. Then to confirm relevance of them, advice from a pediatrician with breastfeeding and formula-feeding knowledge was obtained. Further feedback from another researcher who have breastfeeding and formula-feeding knowledge was also sought. Finally, I obtained permission to use the messages from the authors.
Risks of formula-feeding mentions health and developmental risks of formula for infants and children. Japanese version consists of 815 letters.
Participants will be required to read intervention and to complete a questionnaire online, which will take about 30 minutes.
Interventions/Control_3
Sukoyakana ninshin to syussan no tameni was created by the Ministry of Health, Labour and Welfare. We extracted the message from the website. The message was chosen since it included information about raising children without breastfeeding and formula-feeding. It mentions how to spend time during pregnancy and danger signs during pregnancy. It also contains the similar number of letters as Benefits of breastfeeding and Risks of formula-feeding.
Participants will be required to read intervention and to complete a questionnaire online, which will take about 30 minutes.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants will be required to read Japanese.
Nurses who have work experiences in Obstetrics, Pediatrics and/or NICU/GCU.
Key exclusion criteria
No exclusion criteria
Target sample size
147
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Nanishi |
Organization
Graduate School of Medicine
The University of Tokyo
Division name
International Academic Affairs
Zip code
113-0033
Address
Igakubu Sogo-chuokan 203 Graduate School of Medicine The University of Tokyo 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033 Japan
TEL
0358413689
keikonanishi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Toda |
Organization
Graduate School of Medicine The University of Tokyo
Division name
Community and Global Health
Zip code
113-0033
Address
Igakubu 3 gokan 5F Graduate School of Medicine The University of Tokyo 7-3-1 Hongo Bunkyo-ku Tokyo
TEL
03-5841-3698
Homepage URL
ayumitoda19@gmail.com
Sponsor or person
Institute
Department of Community and Global Health
School of International Health
Graduate School of Medicine
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Department of Community and Global Health
School of International Health
Graduate School of Medicine
The University of Tokyo
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Research Ethics Committee of the Graduate School of Medicine of the University of Tokyo, Japan.
Address
Igakubu 2 gokan S101,S102 Graduate School of Medicine The University of Tokyo 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033 Japan
Tel
0358410818
ethics@m.u-tokyo.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
| 2016 | Year | 08 | Month | 05 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 14 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 14 | Day |
Date trial data considered complete
| 2016 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 25 | Day |
Last modified on
| 2023 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026869
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