UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019376 |
|---|---|
| Receipt number | R000022404 |
| Scientific Title | Development of internet-based program focusing health literacy for promoting eating vegetables and physical activity |
| Date of disclosure of the study information | 2015/10/16 |
| Last modified on | 2018/10/23 09:56:47 |
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Basic information
Public title
Development of internet-based program focusing health literacy for promoting eating vegetables and physical activity
Acronym
Development of internet-based program for promoting eating vegetables and physical activity
Scientific Title
Development of internet-based program focusing health literacy for promoting eating vegetables and physical activity
Scientific Title:Acronym
Development of internet-based program for promoting eating vegetables and physical activity
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of promoting eating vegetables and physical activity internet-based program focusing health literacy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eating vegetables
The subjects were asked about the number of vegetable dishes consumed in a day.
Anonymous questionnaire.
Evaluation will be performed at the before the intervention, the 5 weeks after the intervention and the 3 months after the intervention.
Key secondary outcomes
Physical activity
Health literacy
the Stages of Change for exercise behavior
the Stages of Change for eating vegetables
Knowledge of eating vegetables
Self-efficacy of eating vegetables
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Health education with internet-based program
Intervention period :5 weeks
Intervention frequency :Twice a week
Ten times of information update in total
Intervention frequency :Around 2,000 characters about once
Intervention frequency :Reading of a sentence and the photograph
Interventions/Control_2
Waiting for 5 weeks
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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
None
Key exclusion criteria
Household income > 10 million
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Arao |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
Address
2-579-15 Mikajima, Tokorozawa city, Saitama
TEL
0429-47-6779
tarao@waseda.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Arao |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
Address
2-579-15 Mikajima, Tokorozawa city, Saitama
TEL
0429-47-6779
Homepage URL
tarao@waseda.jp
Sponsor or person
Institute
Arao loboratory, Faculty of Sports Sciences, Waseda university
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Metropolitan University
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
| 2015 | Year | 10 | Month | 16 | 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
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
| 2015 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 15 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 16 | Day |
Last modified on
| 2018 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022404
| 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 |
