Ma'n H. Zawati, Jianxia Fan, Peter C.K. Leung, Janelle Zhan, Antoine Lewin, Yan Jin, Maria P. Velez, Rong Zhang, Benoît Mâsse, William D. Fraser, Isabelle Marc, Xinzhi Zhao, Zhirou Chen, Sonia Semenic, Han Liu, Yan-Hui Hao, Linda Booij, Nadia Abdelouahab, Hong Jiang, Liping Wang, Bartha Maria Knoppers, He-Feng Huang, Lise Dubois, Xin-Mei Liu, Jiahao Wu, Yanting Wu, Wen Yu, Chen Lei, Huijuan Zhang, Amélie Tétu, Anita L. Kozyrskyj, Wenli Fang, Fengxiu Ouyang, Jian Xu, Catherine Allard, Hanqiu Zhang, C M Herba, Nils Chaillet, Hong Li, Yamei Yu, Yan Ding, Jean-Patrice Baillargeon, Jian Shen, Isabel Fortier, Xi Yang, Xiang Peng Liao, Louise C. Masse, Zhong-Cheng Luo, Weibin Wu, Caroline Vaillancourt, Jun Zhang, Luigi Bouchard, and Wenguang Sun
IntroductionChildhood overweight and obesity (OWO) is a primary global health challenge. Childhood OWO prevention is now a public health priority in China. The Sino-Canadian Healthy Life Trajectories Initiative (SCHeLTI), one of four trials being undertaken by the international HeLTI consortium, aims to evaluate the effectiveness of a multifaceted, community-family-mother-child intervention on childhood OWO and non-communicable diseases risk.Methods and analysisThis is a multicentre, cluster-randomised, controlled trial conducted in Shanghai, China. The unit of randomisation is the service area of Maternal Child Health Units (N=36). We will recruit 4500 women/partners/families in maternity and district level hospitals. Participants in the intervention group will receive a multifaceted, integrated package of health promotion interventions beginning in preconception or in the first trimester of pregnancy, continuing into infancy and early childhood. The intervention, which is centred on a modified motivational interviewing approach, will target early-life maternal and child risk factors for adiposity. Through the development of a biological specimen bank, we will study potential mechanisms underlying the effects of the intervention. The primary outcome for the trial is childhood OWO (body mass index for age ≥85th percentile) at 5 years of age, based on WHO sex-specific standards. The study has a power of 0.8 (α=0.05) to detect a 30% risk reduction in the proportion of children with OWO at 5 years of age, from 24.4% in the control group to 17% in the intervention group. Recruitment was launched on 30 August 2018 for the pilot study and 10 January 2019 for the formal study.Ethics and disseminationThe study has been approved by the Medical Research Ethics Committee of the International Peace Maternity and Child Health Hospital in Shanghai, China, and the Research Ethics Board of the Centre Intégré Universitaire de Santé et Services Sociaux de l’Estrie–CHUS in Sherbrooke, Canada. Data sharing policies are consistent with the governance policy of the HeLTI consortium and government legislation.Trial registration numberChiCTR1800017773.Protocol versionNovember 11, 2020 (Version #5).