UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019626 |
|---|---|
| Receipt number | R000022686 |
| Scientific Title | The effects of breastfeeding peer support on breastfeeding satisfaction among Japanese mothers: a randomized controlled trial |
| Date of disclosure of the study information | 2015/11/04 |
| Last modified on | 2019/11/06 20:48:21 |
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Basic information
Public title
The effects of breastfeeding peer support on breastfeeding satisfaction among Japanese mothers: a randomized controlled trial
Acronym
The effects of peer support on breastfeeding satisfaction among Japanese mothers
Scientific Title
The effects of breastfeeding peer support on breastfeeding satisfaction among Japanese mothers: a randomized controlled trial
Scientific Title:Acronym
The effects of peer support on breastfeeding satisfaction among Japanese mothers
Region
| Japan |
Condition
Condition
breastfeeding
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of telephone-based peer support on maternal breastfeeding satisfaction, breastfeeding confidence, willingness to support others and breastfeeding status.
Basic objectives2
Others
Basic objectives -Others
Effect
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Maternal breastfeeding satisfaction at 1 and 4 months postpartum, which will be measured by a 5-point Likert-type self-report instrument (a Japanese version of Maternal Breastfeeding Evaluation Scale).
Key secondary outcomes
Maternal breastfeeding confidence at 1 month, willingness to support others at 4 months, and breastfeeding status at 1 and 4 months postpartum.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Women in the intervention group (n = 250) receive conventional care, plus telephone-based peer support at 1-2 weeks, 3 weeks, 6 weeks and 3 months postpartum. They are encouraged to call their peer supporters any time they would like to talk, or have any breastfeeding concerns until 4 months postpartum.
Interventions/Control_2
Women in the control group (n = 250) receive only conventional care, including usual breastfeeding support at hospitals, and neonatal home visits.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Healthy mothers who have a singleton live birth at maternity hospital, are fluent in Japanese, do not have serious illness or disability that could significantly interfere with breastfeeding, are willing to breastfeed, and whose babies are not in NICU when leaving the hospital.
Key exclusion criteria
Mothers who are members of La Leche League, a mother-to-mother peer support group.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masamine |
| Middle name | |
| Last name | Jimba |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Community and Global Health
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5841-3697
mjimba@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Nanishi |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Office of International Academic Affairs
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5841-3689
Homepage URL
keiko50@m.u-tokyo.ac.jp
Sponsor or person
Institute
Department of Community and Global Health, Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
None
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, the University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
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
| 2015 | Year | 11 | Month | 04 | Day |
Related information
URL releasing protocol
https://doi/10.1177/0890334419869601
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1177/0890334419869601
Number of participants that the trial has enrolled
125
Results
On the subscale measuring lifestyle compatibility, participants with peer support had a higher score than those without peer support: regression coefficient 1.54 (95% confidence interval [0.03, 3.04]). The effect size was 0.40 standard deviations among participants with low and mid-level scores at baseline.
Results date posted
| 2019 | Year | 11 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 08 | Month | 22 | Day |
Baseline Characteristics
Breastfeeding mothers were recruited at four maternity hospitals in Japan.
Participant flow
Data were collected 1 month and 4 months postpartum. Among all of the participants (N = 114), those in the intervention group (n = 60) received telephone-based peer support until 4 months postpartum, and participants in the control group (n = 54) received conventional support.
Adverse events
None.
Outcome measures
Breastfeeding satisfaction was measured using the short version of the revised Japanese Maternal Breastfeeding Evaluation Scale.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2017 | 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
| 2015 | Year | 11 | Month | 04 | Day |
Last modified on
| 2019 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022686
