UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002869 |
|---|---|
| Receipt number | 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 12:39:56 |
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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
| Japan |
Condition
Condition
Physical inactivity
Classification by specialty
| Not applicable |
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
| Behavior,custom |
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
| 40 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
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
| 1st name | |
| Middle name | |
| Last name | Yoshio Nakamura |
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
| 1st name | |
| Middle name | |
| Last name | Yoshio Nakamura |
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 or person
Institute
Faculty of Sport Sciences, Waseda University
Institute
Department
Personal name
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
| 2009 | Year | 12 | Month | 11 | Day |
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
| 2009 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 10 | Day |
Last modified on
| 2011 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003431
| Research Plan | |
|---|---|
| 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 |
