儿童生活行为方式的综合干预肥胖的预防-Plos.DOC

PAGE PAGE 1 Dear Editor, Below is the translation of section 4, the study protocol from this study’s proposal. The original is in Chinese and has been scanned as pdf document and uploaded too. Please do not hesitate to let me know if you have any query. Many thanks. Fei Xu 儿童生活行为方式的综合干预：肥胖的预防 Comprehensive Lifestyle Intervention among Chinese Kids: Obesity Prevention （CLICK-OBESITY） SECTION 4. Study Protocol Study design: School-based Cluster-Randomized Controlled Trials. Participants are grader 4 (9 years old) school students in primary schools. Sample size: The sample size was estimated based on the primary outcome variable, BMI. We would like to observe minimum 0.5 kg/m2 difference in BMI between control and intervention group, considering a standard deviation of 3.0 kg/m2. To estimate the design coefficient due to cluster sampling approach used in this study, we investigated the registered students’ number being approximately 150 on average in each grade within local primary schools, and adopted intraclass correlation coefficient (ICC) as 0.005 based on previous similar studies conducted in other countries. Then, we calculated that the design coefficient was 1.75. Therefore, we estimated that approximately 1200 participants from 8 primary schools might be sufficient for us to detect the change in BMI between these two groups with 80% statistical power based onα= 0.05 (one-side). Sampling method: Multi-stage sampling method was used to randomly select 8 primary schools from Jianye district. The randomization was at school level. All grade 4 students within chosen schools will be the eligible participants. Prior to implement, all participating schools, students and their parents/guardians will be asked to sign the written informed consent. Questionnaire survey There will be two rounds surveys, the baseline and follow-up (after intervention) survey. All the information, integrated into one questionnaire, will be collected through face-to-face interviewIn act