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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018498
Receipt No. 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

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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
Email 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
Email yumi@rehab.osakafu-u.ac.jp

Sponsor
Institute Osaka Prefecture University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021344

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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