Watanabe Junko, Watanabe Mariko, Yamaoka Kazue, Adachi Misa, Nemoto Asuka, Tango Toshiro
The Department of Nutrition Management, Minami Kyushu University, Miyazaki, Japan.
Showa Women's University, Tokyo, Japan.
BMJ Open. 2018 Feb 16;8(2):e018938. doi: 10.1136/bmjopen-2017-018938.
Severe subjective psychosomatic symptoms (SPS) in adolescents are a major public health concern, and lifestyle modification interventions for reducing SPS are important topics. Recently, we developed a school-based lifestyle education involving parents for reducing SPS of adolescents (SPRAT), an improved version of the programme from our previous study Programme for adolescent of lifestyle education in Kumamoto (PADOK). This study aimed to evaluate the effectiveness of SPRAT in reducing SPS among adolescents.
This is a 6-month, cluster randomised clinical trial with two intervention arms (SPRAT vs usual school education). The study population will be composed of middle school students (aged 12-14 years) with their parents/guardians in Japan. SPRAT is expected to be a more powerful programme than PADOK as it reinforces the role of parent participation. The primary endpoint will be the change from baseline SPS scores to those obtained after 6 months. Between-group differences will be analysed following the intention-to-treat principle. Crude and multivariate adjusted effects will be examined using a general linear mixed-effects model for continuous variables and a logistic regression model for dichotomous variables. The sample size required was determined based on the information needed to detect a difference in the primary outcome with a significance level of 5% and power of 80% under the assumptions of 40 students per cluster (assuming the same sample size for each cluster), an effect size of 0.3 and an intraclass correlation coefficient of 0.02. In total, participation by 28 schools (14 schools in each arm) (students: n=1120) will be needed.
This study was approved by the Medical Ethical Committee of Minami Kyushu University in 2017 (number 137). The findings will be disseminated widely through peer-reviewed publications and conference presentations.
UMIN000026715; Pre-results.
青少年严重的主观身心症状（SPS）是一个重大的公共卫生问题，通过改变生活方式来减少SPS的干预措施是重要课题。最近，我们开发了一项面向青少年的基于学校的生活方式教育项目，该项目让家长参与其中以减少青少年的SPS（SPRAT），它是我们之前在熊本开展的青少年生活方式教育项目（PADOK）的改进版本。本研究旨在评估SPRAT在减少青少年SPS方面的效果。
这是一项为期6个月的整群随机临床试验，有两个干预组（SPRAT组与常规学校教育组）。研究对象将由日本12至14岁的中学生及其父母/监护人组成。由于SPRAT强化了家长参与的作用，预计它比PADOK更有效。主要终点将是从基线SPS评分到6个月后所获评分的变化。组间差异将按照意向性分析原则进行分析。对于连续变量，将使用一般线性混合效应模型来检验粗效应和多变量调整效应；对于二分变量，将使用逻辑回归模型。所需样本量是根据在每个整群40名学生（假设每个整群样本量相同）、效应量为0.3以及组内相关系数为0.02的假设下，检测主要结局差异所需的信息确定的，显著性水平为5%，检验效能为80%。总共需要28所学校参与（每组14所学校）（学生：n = 1120）。
本研究于2017年获得南九州大学医学伦理委员会批准（编号137）。研究结果将通过同行评审出版物和会议报告广泛传播。
UMIN000026715；预结果。
