UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012525 |
|---|---|
| Receipt number | R000014658 |
| Scientific Title | Randomized controlled trial to assess effectiveness of dietary lifestyle education program for adolescents in middle schools( PADOK). |
| Date of disclosure of the study information | 2013/12/09 |
| Last modified on | 2014/12/28 21:08:06 |
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Basic information
Public title
Randomized controlled trial to assess effectiveness of dietary lifestyle education program for adolescents in middle schools( PADOK).
Acronym
Evaluation of PADOK Program based on RCT
Scientific Title
Randomized controlled trial to assess effectiveness of dietary lifestyle education program for adolescents in middle schools( PADOK).
Scientific Title:Acronym
Evaluation of PADOK Program based on RCT
Region
| Japan |
Condition
Condition
indefinite complaints
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of dietary lifestyle education program for adolescents (PADOK) on reduction of indefinite complaints based on a cluster randomized controlled trial in middle schools.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of a number of indefinite complaints from baseline
Key secondary outcomes
(Changes from baseline to 6 months)
dietary intakes(energy and nutrients),etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
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
To assess dietary habit using FFQW82 and
to conduct 6 months tailor-made dietary
lifestyle education program for
adolescents by registered dietitian.
Interventions/Control_2
To assess dietary habit using FFQW82 and
return the assessment sheet without any
education and to conduct the usual
education in a junior high school.
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
| 12 | years-old | < |
Age-upper limit
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Boy and girl adolescents of junior high school(First and the second graders,12-15 years old).
2)Those by whom an parent informed consent was obtained.
3)Those who cooperate with the program,follow the instructions of teachers and
comply with regulations.
Key exclusion criteria
1) Boy and girl adolescents of junior
high school who are diagnosed as mental
illness that affects indefinite
complaints.
2) Those who repetitively reject to
attend classes, or refuse to go to school.
3) Those who are judged as inappropriate
for the trial by school nurses because
of health problems.
4) Those who are judged as inappropriate by teachers.
Target sample size
720
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junko Watanabe |
Organization
Prefectural University of Kumamoto
Division name
Center for Community Collaboration
Zip code
Address
3-1-100 Thukide, Higasiku, Kumamoto , Japan
TEL
096-321-6720
j-wata3211@pu-kumamoto.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junko Watanabe |
Organization
Prefectural University of Kumamoto
Division name
Center for Community Collaboration
Zip code
Address
3-1-100 Thukide, Higasiku, Kumamoto , Japan
TEL
096-321-6720
Homepage URL
j-wata3211@pu-kumamoto.ac.jp
Sponsor or person
Institute
Prefectural University of Kumamoto
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
| 2013 | Year | 12 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
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
| 2013 | Year | 12 | Month | 09 | Day |
Last modified on
| 2014 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014658
