UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037681
Receipt number R000040350
Scientific Title Evaluation of PreConception Care Health Education Program for Female Workers of Reproductive Age
Date of disclosure of the study information 2019/08/14
Last modified on 2019/11/11 14:53:30

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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 or person

Institute

Osaka Medical College

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040350


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name