![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000002869 |
Receipt No. | R000003431 |
Scientific Title | Effect of leisure activity intervention on behavioral change for physical activity among low-motivated people |
Date of disclosure of the study information | 2009/12/11 |
Last modified on | 2011/04/06 |
Basic information | ||
Public title | Effect of leisure activity intervention on behavioral change for physical activity among low-motivated people | |
Acronym | Leisure activity and behavior change for physical activity among low-motivated peple | |
Scientific Title | Effect of leisure activity intervention on behavioral change for physical activity among low-motivated people | |
Scientific Title:Acronym | Leisure activity and behavior change for physical activity among low-motivated peple | |
Region |
|
Condition | ||
Condition | Physical inactivity | |
Classification by specialty |
|
|
Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To examine the effectiveness of leisure activity intervention for promoting behavioral change for physical activity and reducing sedentary behavior among low-motivated people |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Physical activity
Stages of change for exercise Sedentary behavior |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | No treatment |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Educational,Counseling,Training | |
Type of intervention |
|
|
Interventions/Control_1 | Intervention group:
To send the email about leisure activity twice a week for 8 weeks |
|
Interventions/Control_2 | Control group:
To live as usual |
|
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | 1) Those who are precontemplation stage for
exercise 2) Those who live in Tokyo |
|||
Key exclusion criteria | 1) Those who do not have mobile phone | |||
Target sample size | 700 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Waseda University | ||||||
Division name | Faculty of Sport Sciences | ||||||
Zip code | |||||||
Address | 2-579-15, Mikajima, Tokorozawa, Saitama | ||||||
TEL | |||||||
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Waseda University | ||||||
Division name | Faculty of Sport Sciences | ||||||
Zip code | |||||||
Address | 2-579-15, Mikajima, Tokorozawa, Saitama | ||||||
TEL | |||||||
Homepage URL | |||||||
nakamura@waseda.jp |
Sponsor | |
Institute | Faculty of Sport Sciences, Waseda University |
Institute | |
Department |
Funding Source | |
Organization | Ministry of Education, Culture, Sports, Science and Technology |
Organization | |
Division | |
Category of Funding Organization | |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
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 |
|
Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | After the intervention period, while 26.5% moved from precontemplation stage to over contemplation in the control group, 54.9% of the intervention group moved to over contemplation (p<.001). No significant differences were found between IG and CG in the change of physical activity and sedentary behavior. (Katayama Y, Harada K, & Nakamura Y. Effect of Leisure Activity-related Information on Motivational Readiness in Exercise Behavior. Journal of Japan Society of Sports Industry, 2001; 21: 27-39. [in Japanese]) |
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 | Completed | ||||||
Date of protocol fixation |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003431 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |