Randomized controlled trial to assess effectiveness of school-based parent-participation lifestyle Education program(SPRAT) on reducing subjective Psychosomatic symptoms (SPS) in adolescents - Evaluation of SPRAT program based on RCT

Minami kyusyu University0 sites2,150 target enrollmentMarch 27, 2017

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: Minami kyusyu University
Enrollment: 2150
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

who.int

Start Date

March 27, 2017

End Date

March 31, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Minami kyusyu University

Eligibility Criteria

Inclusion Criteria

Not provided

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.