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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026715
Receipt No. R000030667
Scientific Title Randomized controlled trial to assess effectiveness of school-based parent-participation lifestyle Education program(SPRAT) on reducing subjective Psychosomatic symptoms (SPS) in adolescents
Date of disclosure of the study information 2017/03/27
Last modified on 2019/04/01

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Basic information
Public title Randomized controlled trial to assess effectiveness of school-based parent-participation lifestyle
Education program(SPRAT) on reducing subjective Psychosomatic symptoms (SPS) in adolescents
Acronym Evaluation of SPRAT program based on RCT
Scientific Title Randomized controlled trial to assess effectiveness of school-based parent-participation lifestyle
Education program(SPRAT) on reducing subjective Psychosomatic symptoms (SPS) in adolescents
Scientific Title:Acronym Evaluation of SPRAT program based on RCT
Region
Japan

Condition
Condition Subjective Psychosomatic Symptoms
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effectiveness of school-based parent-participation lifestyle education program (SPRAT) on reducing Subjective Psychosomatic Symptoms (SPS) in adolescents on a cluster randomized controlled trial.
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 Subjective Psychosomatic Symptoms (SPS) from baseline to 6 months.
Key secondary outcomes (Changes from baseline to 6 months) BMI, dietary intakes (energy and nutrients), lifestyle factors for students (habit of sleeping, eating of breakfast, fatty snake or meal, soft drink and physical activity, the time spent on computer games, mobile phones, internet, and watching television, school-life.)

Change of a number of Subjective Psychosomatic Symptoms (SPS) for students from the baseline to after 2 and 4 months.

(Changes from baseline to 6 months)
Assess of parent-participation for his (her) child lifestyle modification of lifestyle factors (lifestyle factors : habit of sleeping, eating of breakfast, fatty snake or meal, soft drink, and physical activity).

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 intakes (FFQW82) and to conduct 6 months tailor-made
school-based parent-participation lifestyle education program
(SPRAT) on reducing subjective psychosomatic symptoms (SPS) in adolescents by registered dietitian.
Interventions/Control_2 To assess dietary intakes(FFQW82) and return the assessment sheet without any education and to conduct the usual education in the middle 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
14 years-old >=
Gender Male and Female
Key inclusion criteria 1) Boy and girl adolescents of middle school (First and the Second graders, 12-14 years old).
2) Boys and girls adolescents who have been obtained informed consents both from them and their parents (or gardener).
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 middle school who are diagnosed as mental illness that affects SPS.
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 2240

Research contact person
Name of lead principal investigator
1st name JUNKO
Middle name
Last name WATANABE
Organization Minami kyusyu University
Division name Department of Nutrition Management
Zip code 880-0032
Address 5-1-2 Kirishima , Miyazaki,Japan
TEL 0985-83-3570
Email j-wata@nankyudai.ac.jp

Public contact
Name of contact person
1st name JUNKO
Middle name
Last name WATANABE
Organization Minami kyusyu University
Division name Department of Nutrition Management
Zip code 880-0032
Address 5-1-2 Kirishima , Miyazaki,Japan
TEL 0985-83-3570
Homepage URL
Email j-wata@nankyudai.ac.jp

Sponsor
Institute Minami kyusyu University
Institute
Department

Funding Source
Organization Miyazaki City office
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Minami kyusyu University
Address 5-1-2 Kirishima , Miyazaki,Japan
Tel 0985-83-3570
Email j-wata@nankyudai.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

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 27 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 No longer recruiting
Date of protocol fixation
2017 Year 07 Month 22 Day
Date of IRB
2017 Year 07 Month 22 Day
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 27 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030667

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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