UMIN-CTR Clinical Trial

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	https://bmjopen.bmj.com/content/bmjopen/8/2/e018938.full.pdf
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/35255866/
Number of participants that the trial has enrolled	2150
Results	We devevaluat a school-based dietary and lifestyle education programme that involved parents/guardians in reducing SPS in adolescents (SPRAT).Participants were middle school students in Japan who provided informed consent. Change from baseline (CFB) at 6 months was the primary endpoint.The CFB was lower in the SPRAT group (-0.29) than in the control group (0.62), but the difference was not statistically significant -0.91(p = 0.093).Favourable effects were observed in some secondary outcomes.
Results date posted	2022 Year 09 Month 30 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	School was the unit for cluster randomisation.Participants were all eligible adolescents of these middle schools in school years 1 and 2(age 12-14 years).The participants were registered between October 2018 and December 2019.Parents/guardians in the SPRAT group were asked to join the programme to help their children.
Participant flow	1.Enrollment Recruited middle schools:N=28 2.Allocation　 Randomization of middle schools 　　　　　　　(N=23,n=2277) 3.Allocated to SPRAT group(N=11,n=1054) 　　　　　　 control group(N=12,n=1223) 4.Excluded. Didn't agree (SPRAT n=37,control n=38) Absentees with long-term sickness (SPRAT n=13,control n=32) 5.Assessed eligibility students and their parents (SPRAT N=11,n=1004 control N= 12, n=1153) 6.Analysed(SPRAT N=11,n=951 control N=12, n=1035)
Adverse events	None
Outcome measures	The primary outcome was the SPS score at 6 months from baseline measured by responses to the SPQ, which consists of questions on nine symptoms such as fatigue, headache, lassitude, irritation, lack of concentration, lack of motivation, poor ability to wake up in the morning, upset stomach and stiff shoulder. Secondary outcomes were the SPS score at 2 and 4 months from baseline, dietary and lifestyle factors (sleeping habits, eating habits, enjoyable school life, and physical activity), and dietary intake (11 energy intakes by food group and 9 nutrients) assessed by the FFQW82 and body mass index (BMI) at 6 months from baseline.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
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	2022 Year 09 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030667