UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048183
Receipt number R000054908
Scientific Title A Scoping Review of Health Behavior Changes in Preconception Care for Women
Date of disclosure of the study information 2022/06/28
Last modified on 2023/03/02 15:24:06

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Basic information

Public title

A Scoping Review of Health Behavior Changes in Preconception Care for Women

Acronym

A Scoping Review of Health Behavior Changes in Preconception Care for Women

Scientific Title

A Scoping Review of Health Behavior Changes in Preconception Care for Women

Scientific Title:Acronym

A Scoping Review of Health Behavior Changes in Preconception Care for Women

Region

Japan


Condition

Condition

Preconception women

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aimed to clarify the components of preconception care interventions, and effects of interventions in preconception women and examine how to support lifestyle improvement in preconception women, focusing on intervention methods for each population groups of preconception health risks.

Basic objectives2

Others

Basic objectives -Others

Behavior change

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Improving the lifestyle of preconception women to improve the health of self and future pregnancies

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

15 years-old <=

Age-upper limit

49 years-old >

Gender

Female

Key inclusion criteria

Population: Preconception women between the ages of 15 and 49 (reproductive age)
Concept: The following search terms were used; preconception*, interconception*,
preconceptual*, and interconceptual*
Context:
- Written in Japanese or English
- All settings were included
- Randamized controlled trials (RCTs), including cluster RCTs, quasi-RCTs, followup
study of RCTs

Key exclusion criteria

- Subjects are different such as studies are conducted on male subjects only
- Research using languages other than Japanese or English
- Case studies and observational studies

Target sample size



Research contact person

Name of lead principal investigator

1st name Hitomi
Middle name
Last name Suzuki

Organization

St. Luke's international university

Division name

Graduate School of Nursing Science

Zip code

104-0044

Address

10-1, Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan

TEL

03-3543-6391

Email

21dn007@slcn.ac.jp


Public contact

Name of contact person

1st name Hitomi
Middle name
Last name Suzuki

Organization

St. Luke's international university

Division name

Graduate School of Nursing Science

Zip code

104-0044

Address

10-1, Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan

TEL

03-3545-6391

Homepage URL


Email

21dn007@slcn.ac.jp


Sponsor or person

Institute

St. Luke's International University

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

St. Luke's International University

Address

10-1, Akashi-cho, Chuo-ku, Tokyo, Japan

Tel

0335436391

Email

21dn007@slcn.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

2022 Year 06 Month 28 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

2022 Year 04 Month 01 Day

Date of IRB

2022 Year 04 Month 01 Day

Anticipated trial start date

2022 Year 04 Month 01 Day

Last follow-up date

2022 Year 04 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This scoping review will detaile prominent topics that discuss the target population, areas of outcome(s), intervention characteristics, and types of measures. In addition, strategies for behavior change for each population was analyzed by categorizing them by their preconception health risks.
This review presents how preconception care for women differs according to their preconception health risk and provides suggestions for future research. The set of study data presented the results in the form of tables and flow charts.


Management information

Registered date

2022 Year 06 Month 28 Day

Last modified on

2023 Year 03 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054908


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name