UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000019626
Receipt No. 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 (Ver. 17)

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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
Email 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
Email keiko50@m.u-tokyo.ac.jp

Sponsor
Institute Department of Community and Global Health, Graduate School of Medicine, The University of Tokyo
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022686