Wu Yanting, Marc Isabelle, Bouchard Luigi, Ouyang Fengxiu, Luo Zhong-Cheng, Fan Jianxia, Dubois Lise, Mâsse Benoît, Zhang Jun, Leung Peter C K, Liao Xiang Peng, Herba C M, Booij Linda, Shen Jian, Lewin Antoine, Jiang Hong, Wang Liping, Xu Jian, Wu Weibin, Sun Wenguang, Wu Jiahao, Li Hong, Lei Chen, Kozyrskyj Anita, Semenic Sonia, Chaillet N, Fortier Isabel, Masse Louise, Zhan Janelle, Allard Catherine, Knoppers Bartha, Zawati Ma'n, Baillargeon Jean-Patrice, Velez Maria P, Zhang Hanqiu, Yu Yamei, Yu Wen, Ding Yan, Vaillancourt Caroline, Liu Han, Tetu Amelie, Fang Wenli, Zhang Rong, Zhao Xinzhi, Jin Yan, Liu Xin-Mei, Zhang Huijuan, Chen Zhirou, Yang Xi, Hao Yan-Hui, Abdelouahab Nadia, Fraser William, Huang He-Feng
International Peace Maternity and Child Health Hospital, Shanghai, China.
Key Laboratory of Embryo Molecular Biology, Ministry of Health, Shanghai, China.
BMJ Open. 2021 Apr 1;11(4):e045192. doi: 10.1136/bmjopen-2020-045192.
Childhood 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.
This 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.
The 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.
ChiCTR1800017773.
November 11, 2020 (Version #5).
儿童超重和肥胖是一项全球性主要健康挑战。儿童超重和肥胖预防如今是中国的一项公共卫生重点工作。中加健康生活轨迹倡议（SCHeLTI）是国际健康生活轨迹（HeLTI）联盟正在开展的四项试验之一，旨在评估一项多方面、社区-家庭-母婴干预措施对儿童超重和肥胖以及非传染性疾病风险的有效性。
这是一项在中国上海开展的多中心、整群随机对照试验。随机分组单位是妇幼保健单位的服务区（N = 36）。我们将在妇产医院和区级医院招募4500名女性/伴侣/家庭。干预组的参与者将从孕前或怀孕头三个月开始接受多方面、综合的健康促进干预措施，并持续至婴儿期和幼儿期。该干预措施以改良的动机性访谈方法为核心，将针对肥胖的早期母婴风险因素。通过建立生物样本库，我们将研究干预效果背后的潜在机制。该试验的主要结局指标是根据世界卫生组织特定性别的标准，5岁儿童的超重和肥胖情况（年龄别体重指数≥第85百分位数）。该研究有80%的检验效能（α = 0.05）来检测5岁超重和肥胖儿童比例降低30%，即从对照组的24.4%降至干预组的17%。试点研究于2018年8月30日启动招募，正式研究于2019年1月10日启动招募。
该研究已获得中国上海国际和平妇幼保健院医学研究伦理委员会以及加拿大舍布鲁克地区综合大学健康与社会服务中心（Centre Intégré Universitaire de Santé et Services Sociaux de l'Estrie-CHUS）研究伦理委员会的批准。数据共享政策与HeLTI联盟的管理政策及政府法规一致。
ChiCTR1800017773。
2020年11月11日（版本#5）。
