UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of PreConception Care Health Education Program for Female Workers of Reproductive Age
Acronym	Evaluation of PreConception Care Health Education Program for Female Workers of Reproductive Age
Scientific Title	Evaluation of PreConception Care Health Education Program for Female Workers of Reproductive Age
Scientific Title:Acronym	Evaluation of PreConception Care Health Education Program for Female Workers of Reproductive Age
Region	Japan

Condition
Condition	health education program to educate preconception care (PCC) for female workers of reproductive age
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to implement a health education program to educate preconception care (PCC) for female workers of reproductive age to evaluate the program based on knowledge, awareness and behaviors regarding PCC before, after and 3,6 months after the seminars.
Basic objectives2	Others
Basic objectives -Others	indicators were feeling of self-efficacy; health awareness, based on the health promotion lifestyle profile scale; and stress management. (before, after and 3,6 months after the seminars.)
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Main outcome indicators were knowledge of PCC; consciousness and behaviors related to PCC; nutrient intake amounts, based on food intake frequency survey. before, after and 3,6 months after the seminars.
Key secondary outcomes	Sub-outcome indicators were feeling of self-efficacy; health awareness, based on the health promotion lifestyle profile scale; and stress management. before, after and 3,6 months after the seminars.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	one health education seminars and one group discussions in small groups using leaflets, and three feedback in the form of comments were provided to the participants.(after and 3 months after the seminars.)
Interventions/Control_2
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	20 years-old <=
Age-upper limit	35 years-old >=
Gender	Female
Key inclusion criteria	female workers of reproductive age, aged 20 to 35 years.
Key exclusion criteria	The person who engaged in pregnant person, physician, dentist, pharmacist, community health nurse, nurse midwife, nurse, work of the dietitian excluded it.
Target sample size	51

Research contact person
Name of lead principal investigator	1st name Ayako Middle name Last name Sasaki
Organization	Osaka Medical College
Division name	The Faculty of Nursing
Zip code	569-0095
Address	7-6 Hattyonishi-machi, Takatsuki-City, osaka, Japan
TEL	072-684-7033
Email	ayabe@osaka-med.ac.jp

Public contact
Name of contact person	1st name Ayako Middle name Last name Sasaki
Organization	Osaka Medical College
Division name	The Faculty of Nursing
Zip code	569-0095
Address	7-6 Hattyonishi-machi, Takatsuki-City, osaka, Japan
TEL	072-684-7033
Homepage URL
Email	ayabe@osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

Funding Source
Organization	Osaka Medical College
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	no
Name of secondary funder(s)	Setsunan University

IRB Contact (For public release)
Organization	Osaka Medical College study Ethical Review Board
Address	2-7, Daigakumachi, Takatsuki-shi, Osaka
Tel	072-683-1221
Email	rinri@osaka-med.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	2018-032
Org. issuing International ID_1	Setsunan university
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 14 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	84
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	Main results already published
Date of protocol fixation	2018 Year 06 Month 18 Day
Date of IRB	2018 Year 06 Month 18 Day
Anticipated trial start date	2018 Year 06 Month 18 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 08 Month 14 Day
Last modified on	2019 Year 11 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040350