UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of a Breastfeeding Self-Efficacy Intervention in a Baby-Friendly Hospital in Lao, PDR
Acronym	Effectiveness of a Breastfeeding Self-Efficacy Intervention in a Baby-Friendly Hospital in Lao, PDR
Scientific Title	Effectiveness of a Breastfeeding Self-Efficacy Intervention in a Baby-Friendly Hospital in Lao, PDR
Scientific Title:Acronym	Effectiveness of a Breastfeeding Self-Efficacy Intervention in a Baby-Friendly Hospital in Lao, PDR
Region	Asia(except Japan)

Condition
Condition	Healthy women
Classification by specialty	Obsterics and gynecology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to assess the effectiveness of breastfeeding support by nurses and midwives who attended a capacity-building program on maternal breastfeeding self-efficacy and breastfeeding duration and exclusivity in a Baby-Friendly Hospital in Lao PDR.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Infant feeding status 6 weeks, 14 weeks, and 6 months postpartum
Key secondary outcomes	Breastfeeding self-efficacy 6 weeks and 14 weeks postpartum

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
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	Behavior,custom
Interventions/Control_1	Women in the control group will receive conventional breastfeeding support in the hospital and in the community.
Interventions/Control_2	Women in the intervention group will also receive conventional breastfeeding support. Those in the intervention group will also receive individual breastfeeding counseling, based on their responses to the Breastfeeding Self-Efficacy Scale -Short From, which consists of 14 items relating to breastfeeding practices. Before discharge, they receive face-to-face individual breastfeeding counseling by a trained nurse or midwife for about 15-to-30 minutes. After discharge, women will receive a phone call 1 week, 3 weeks, and 9 weeks after birth by a trained nurse or midwife to talk about any breastfeeding difficulties. Each session of telephone counseling will take about 5-to-15 minutes.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Eligibility criteria include the ability to participate in Laotian, and having had a singleton birth.
Key exclusion criteria	If either the women or her infant has a medical condition that can interfere with breastfeeding, she will be excluded from the study.
Target sample size	400

Research contact person
Last name of lead principal investigator	1st name Keiko Middle name Last name Nanishi
Organization	The University of Tokyo
Division name	Graduate School of Medicine
Zip code	113-0033
Address	Office of International Academic Affairs, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-5841-3689
Email	keiko50@m.u-tokyo.ac.jp

Public contact
1st name of contact person	1st name Keiko Middle name Last name Nanishi
Organization	The University of Tokyo
Division name	Graduate School of Medicine
Zip code	113-0033
Address	Office of International Academic Affairs, Graduate School of Medicine, The University of Tokyo, 7-3-
TEL	03-5841-3689
Homepage URL
Email	keiko50@m.u-tokyo.ac.jp

Sponsor
Institute	Graduate School of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Lao Tropical and Public Health Institute, Ministry of Health, Lao People's Domestic Republic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Ethics Committee, 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	Mother and Child Hospital in Vientiane

Other administrative information
Date of disclosure of the study information	2017 Year 09 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	392
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	2017 Year 05 Month 12 Day
Date of IRB	2017 Year 05 Month 17 Day
Anticipated trial start date	2017 Year 09 Month 18 Day
Last follow-up date	2018 Year 10 Month 31 Day
Date of closure to data entry	2018 Year 11 Month 30 Day
Date trial data considered complete	2018 Year 12 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 08 Month 23 Day
Last modified on	2019 Year 05 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032947