UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018498 |
|---|---|
| Receipt number | R000021344 |
| Scientific Title | Sedentary time and health-related quality of life among housewives: A comparison of individual instruction |
| Date of disclosure of the study information | 2015/08/10 |
| Last modified on | 2019/08/03 14:10:34 |
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Basic information
Public title
Sedentary time and health-related quality of life among housewives:
A comparison of individual instruction
Acronym
Sedentary time and health-related quality of life among housewives:
A comparison of individual instruction
Scientific Title
Sedentary time and health-related quality of life among housewives:
A comparison of individual instruction
Scientific Title:Acronym
Sedentary time and health-related quality of life among housewives:
A comparison of individual instruction
Region
| Japan |
Condition
Condition
Healthy housewives
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Health promotion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1 week of Sedentary behavior before and after intervention
Key secondary outcomes
1 week of Health-related Quality of life before and after intervention
Lower leg volume before intervention and after intervention 1 week
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
1 Pamphlet distribution(+)
Self feedbaack for 1 week(-)
Individualized instruction for 10 minutes(-)
Interventions/Control_2
1 Pamphlet distribution(+)
Self feedbaack for 1 week(+)
Individualized instruction for 10 minutes(-)
Interventions/Control_3
1 Pamphlet distribution(+)
Self feedbaack for 1 week(+)
Individualized instruction for 10 minutes(+)
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy housewives
Key exclusion criteria
Person who does not have a following of children elementary school
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Kitagawa |
Organization
Shijonawate Gakuen University
Division name
Faculty of Rehabilitation
Zip code
5740011
Address
5-11-10, Hojo, Daito-shi
TEL
072-863-5043
t-kitagawa@reha.shijonawate-gakuen.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Higuchi |
Organization
Osaka Prefecture University
Division name
Graduate School of Comprehensive Rehabilitation
Zip code
5838555
Address
3-7-30,Habikino,Habikino City
TEL
072-950-2111
Homepage URL
yumi@rehab.osakafu-u.ac.jp
Sponsor or person
Institute
Osaka Prefecture University
Institute
Department
Personal name
Funding Source
Organization
Shijonawate Gakuen University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Osaka Prefecture University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Committee on Research Ethics, The School of Comprehensive Rehabilitation, Osaka Prefecture University
Address
3-7-30,Habikino,Habikino City
Tel
072-950-2111
yumi@rehab.osakafu-u.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
四條畷学園大学（大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
https://www.tandfonline.com/loi/wwah20
Publication of results
Published
Result
URL related to results and publications
https://www.tandfonline.com/loi/wwah20
Number of participants that the trial has enrolled
48
Results
The longest prolonged sitting time showed
a significant reduction over time in all groups with a large effect size.
A post hoc analysis revealed that the longest prolonged sitting time was only significantly reduced in the tailored feedback group.
In Health-related QOL, vitality, mental health, and role emotional showed a significant improvement after the intervention in all groups with a medium to large effect size.
Results date posted
| 2019 | Year | 08 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Aged 20 to 50 years, housewife, had a child who was in lower than primary school, and did not have a disease or was undergoing treatment.
Forty eight women with an average age of 38.0 years completed the study.
Participant flow
Participants visited the research facility or measurement rooms three times in total.
At the first visit, participants received an explanation, basic measurements were taken, and a wristband-type accelerometer was provided.
At the second visit, one week later, participants underwent a health condition measurements, and the intervention was provided.
At the third visit, one week later, research staff measured the participant' health condition and collected the accerelometer data.
Adverse events
There were no adverse events.
Outcome measures
The longest prolonged sitting time, the numberof steps, and the total physical activity time were measured daily before and after the intervention.
Health-related QOL was measured at the end of the first and second weeks using the
Japanese version of the short-form 8 (SF-8) questionnaire.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2014 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2016 | 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
| 2015 | Year | 07 | Month | 31 | Day |
Last modified on
| 2019 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021344
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
