UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032327 |
|---|---|
| Receipt number | R000036851 |
| Scientific Title | Effect of the intervention program to reduce sedentary behavior of pregnant women |
| Date of disclosure of the study information | 2018/05/28 |
| Last modified on | 2021/04/22 13:11:22 |
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Basic information
Public title
Effect of the intervention program to reduce sedentary behavior of pregnant women
Acronym
Effect of the intervention program to reduce sedentary behavior of pregnant women
Scientific Title
Effect of the intervention program to reduce sedentary behavior of pregnant women
Scientific Title:Acronym
Effect of the intervention program to reduce sedentary behavior of pregnant women
Region
| Japan |
Condition
Condition
Healthy pregnant women
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of the intervention program to reduce the sedentary behavior of pregnant women.
(Historical control is the previous data of the pregnant women.)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sedentary time
Key secondary outcomes
amount of physical activity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
1) one-on-one health guidance
2) using activity monitor and the application to self-monitoring on sedentary behavior (after 20 gestational weeks until child birth)
3) receive vibration notification from activity monitor when sitting for 1 hour or more (after 20 gestational weeks until child birth)
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
Healthy pregnant women without restriction of physical activity
Key exclusion criteria
1) less than 20 years old
2) with inadequate Japanese literacy
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yasuka |
| Middle name | |
| Last name | NAKAMUA |
Organization
Tohoku University
Division name
Graduate school of Medicine Womens health nursing
Zip code
9808575
Address
2-1 Seiryo-machi, Aoba-ku, sendai, miyagi, JAPAN
TEL
+81227177957
ynaka@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yasuka |
| Middle name | |
| Last name | NAKAMURA |
Organization
Tohoku University
Division name
Graduate school of Medicine Womens health nursing
Zip code
9808575
Address
2-1 Seiryo-machi, Aoba-ku, sendai, miyagi, JAPAN
TEL
022-717-7957
Homepage URL
ynaka@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate school of Med
Address
2-1 Seiryo-machi, Aoba-ku, sendai, miyagi, JAPAN
Tel
0227177957
ynaka@tohoku.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
| 2018 | Year | 05 | Month | 28 | Day |
Related information
URL releasing protocol
https://doi.org/10.3390/healthcare8040439
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3390/healthcare8040439
Number of participants that the trial has enrolled
69
Results
In 56 women, the mean wearing time was 90.2 days in the intervention phase. The response rate to automatic SB alerts was 55.5% at T1 and 63.0% at T2. Self-monitoring more than twice or thrice a week was 77.8% at T1 and 59.3% at T2. There was no significant difference in the cumulative SB time at T2 between the intervention and control groups (F = 2.31, p = 0.132). This program appears to be acceptable and feasible for pregnant women; however, SB reduction effect of the intervention remains unclear.
Results date posted
| 2021 | Year | 04 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Sixty-nine pregnant women
Participant flow
Event of medical physical activity restriction (n=1)
Lost to follow-up (n=1)
Declined to participate (n=1)
The number of wearing days was less than 7 days of 4weeks in T1 and/or T2 (n=10)
Adverse events
None
Outcome measures
Cumulative sedentary behavior time
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 20 | Day |
Last modified on
| 2021 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036851
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| Registered date | File name |
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