UMIN-CTR Clinical Trial

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

Subjective Psychosomatic Symptoms

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

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

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).

Study type

Interventional

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

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

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

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

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

Institute

Minami kyusyu University

Institute

Department

Personal name

Organization

Miyazaki City office

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Minami kyusyu University

Address

5-1-2 Kirishima , Miyazaki,Japan

Tel

0985-83-3570

Email

j-wata@nankyudai.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

03

Month

27

Day

URL releasing protocol

https://bmjopen.bmj.com/content/bmjopen/8/2/e018938.full.pdf

Publication of results

Published

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

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 related information

Registered date

2017

Year

03

Month

27

Day

Last modified on

2022

Year

09

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030667