| 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 (Ver. 8) |
| 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 |
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| Condition | ||
| Condition | Healthy housewives | |
| Classification by specialty |
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| 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 |
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| Interventions/Control_1 | 1 Pamphlet distribution(+)
Self feedbaack for 1 week(-) Individualized instruction for 10 minutes(-) |
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| Interventions/Control_2 | 1 Pamphlet distribution(+)
Self feedbaack for 1 week(+) Individualized instruction for 10 minutes(-) |
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| Interventions/Control_3 | 1 Pamphlet distribution(+)
Self feedbaack for 1 week(+) Individualized instruction for 10 minutes(+) |
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| 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 |
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| Age-upper limit |
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| 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 |
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| 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 |
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| 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 | |
| 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 |
| 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 |
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| 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. |
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| Results date posted |
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| 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. |
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| 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. |
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| Adverse events | There were no adverse events. |
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| 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. |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Main results already published | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date of closure to data entry | |||||||
| Date trial data considered complete | |||||||
| Date analysis concluded | |||||||
| Other | |
| Other related information | |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021344 |