UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047343 |
|---|---|
| Receipt number | R000053993 |
| Scientific Title | Development of a Nursing Intervention Program to Promote Physical Activity in the Daily Life of Pregnant Women |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2023/10/29 01:16:14 |
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Basic information
Public title
Development of a Nursing Intervention Program to Promote Physical Activity in the Daily Life of Pregnant Women
Acronym
Development of a Nursing Intervention Program to Promote Physical Activity in the Daily Life of Pregnant Women
Scientific Title
Development of a Nursing Intervention Program to Promote Physical Activity in the Daily Life of Pregnant Women
Scientific Title:Acronym
Development of a Nursing Intervention Program to Promote Physical Activity in the Daily Life of Pregnant Women
Region
| Japan |
Condition
Condition
pregnant women
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a nursing intervention program for pregnant women in the third trimester of pregnancy that will encourage physical activity in the daily life and maintain and promote health during pregnancy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of physical activity
Key secondary outcomes
Physical Activity Recognition, Frequency and degree of awareness of minor symptoms, Comfort level, Adverse event rate
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
1) Provide information using booklets and videos
2) Recommendation of web-based self-monitoring
3) Individual health guidance via video call (two times)
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
| Not applicable |
Gender
Female
Key inclusion criteria
1)Healthy pregnant women without restriction of physical activity
2)Pregnant women with a singleton pregnancy of 26-30 weeks gestation
Key exclusion criteria
1)Less than 20 years old
2)Pregnant women with inadequate Japanese literacy
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Marika |
| Middle name | |
| Last name | Seki |
Organization
Chiba University
Division name
Graduate School of Nursing
Zip code
260-8672
Address
1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba, Japan
TEL
043-222-7171
lilas8blanche12mrk@chiba-u.jp
Public contact
Name of contact person
| 1st name | Marika |
| Middle name | |
| Last name | Seki |
Organization
Chiba University
Division name
Graduate School of Nursing
Zip code
260-8672
Address
1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba, Japan
TEL
043-222-7171
Homepage URL
lilas8blanche12mrk@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
This work was supported by JST SPRING, Grant Number JPMJSP2109.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Graduate School of Nursing, Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba, Japan
Tel
043-226-2462
kango-rinri@chiba-u.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 | 04 | Month | 01 | 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
Suspended
Date of protocol fixation
| 2022 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 31 | Day |
Last modified on
| 2023 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053993
