UMIN-CTR Clinical Trial

Basic information
Public title	Longitudinal research on a parenting support program - HUG Your Baby - for parent-infant bonding
Acronym	HUG Your Baby longitudinal research
Scientific Title	Longitudinal research on a parenting support program - HUG Your Baby - for parent-infant bonding
Scientific Title:Acronym	HUG Your Baby longitudinal research
Region	Japan

Condition
Condition	parenting
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to longitudinally evaluate women who received the HUG Your Baby program during antenatal period may have differences in attachment with the infant and parenting confidence compared to women who did not receive the program
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Maternal confidence, Parenting confidence, Attachment
Key secondary outcomes	Parenting knowledge, Use of HUG Your Baby, Demographics, Postpartum depression, Difficulty in dealing with a crying infant, Abusive intention

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	HUG Your Baby Program - Three Zones - SOSs (Signs of Overstimulation) - What to do when a baby cries (What TO DO) - Two types of sleeping (Active/Light sleep, Still/Deep sleep) - Tips for successful breastfeeding
Interventions/Control_2	How to swaddle a baby - How to swaddle correctly - Balancing body temperature (materials of swaddle, what to wear under swaddle)
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Pregnant women with more than 30 weeks gestational age
Key exclusion criteria	Severe complications
Target sample size	128

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoko Shimpuku
Organization	St. Luke's International University
Division name	Women't Health and Midwifery
Zip code
Address	10-1 Akashicho Chuoku Tokyo
TEL	03-5550-2372
Email	yoko-shimpuku@slcn.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yoko Shimpuku
Organization	St. Luke's International University
Division name	Women't Health and Midwifery
Zip code
Address	10-1 Akashicho Chuoku Tokyo
TEL	03-5550-2372
Homepage URL
Email	yoko-shimpuku@slcn.ac.jp

Sponsor
Institute	St. Luke's International University
Institute
Department

Funding Source
Organization	St. Luke's Life Science Institute
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 01 Month 24 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	2014 Year 12 Month 24 Day
Date of IRB	2015 Year 02 Month 14 Day
Anticipated trial start date	2015 Year 02 Month 28 Day
Last follow-up date	2016 Year 06 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 01 Month 24 Day
Last modified on	2022 Year 01 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018945