BMJ Open (Apr 2021)
Study protocol for the Sino-Canadian Healthy Life Trajectories Initiative (SCHeLTI): a multicentre, cluster-randomised, parallel-group, superiority trial of a multifaceted community-family-mother-child intervention to prevent childhood overweight and obesity
- Rong Zhang,
- Xi Yang,
- Jun Zhang,
- Hong Li,
- Jian Shen,
- Jian Xu,
- Yan Jin,
- Louise Mâsse,
- Zhong-Cheng Luo,
- Lise Dubois,
- Huijuan Zhang,
- Bartha Knoppers,
- He-Feng Huang,
- Jiahao Wu,
- Liping Wang,
- Benoît Mâsse,
- Fengxiu Ouyang,
- Yamei Yu,
- Wenguang Sun,
- William Fraser,
- Isabel Fortier,
- Sonia Semenic,
- Yanting Wu,
- Isabelle Marc,
- Luigi Bouchard,
- Jianxia Fan,
- Peter C K Leung,
- Xiang Peng Liao,
- C M Herba,
- Linda Booij,
- Antoine Lewin,
- Weibin Wu,
- Chen Lei,
- Anita Kozyrskyj,
- N Chaillet,
- Janelle Zhan,
- Catherine Allard,
- Ma'n Zawati,
- Jean-Patrice Baillargeon,
- Maria P Velez,
- Hanqiu Zhang,
- Wen Yu,
- Caroline Vaillancourt,
- Han Liu,
- Amelie Tetu,
- Wenli Fang,
- Xinzhi Zhao,
- Xin-Mei Liu,
- Zhirou Chen,
- Yan-Hui Hao,
- Nadia Abdelouahab
Affiliations
- Rong Zhang
- Department of Obstetrics and Gynecology, Shanghai Fengxian Central Hospital, Shanghai, China
- Xi Yang
- International Peace Maternity and Child Health Hospital, Shanghai, China
- Jun Zhang
- Ministry of Education—Shanghai Key Laboratory of Children’s Environmental Health, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
- Hong Li
- International Peace Maternity and Child Health Hospital, Shanghai, China
- Jian Shen
- Key Laboratory of Systems Biomedicine (Ministry of Education), Shanghai Center for Systems Biomedicine, Shanghai Jiao Tong University, Shanghai, China
- Jian Xu
- International Peace Maternity and Child Health Hospital, Shanghai, China
- Yan Jin
- International Peace Maternity and Child Health Hospital, Shanghai, China
- Louise Mâsse
- School of Population and Public Health, The University of British Columbia, Vancouver, British Columbia, Canada
- Zhong-Cheng Luo
- Mount Sinai Hospital, Lunenfeld-Tanenbaum Research Institute, Toronto, Ontario, Canada
- Lise Dubois
- School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada
- Huijuan Zhang
- Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China
- Bartha Knoppers
- Centre of Genomics and Policy, McGill University, Montreal, Québec, Canada
- He-Feng Huang
- International Peace Maternity and Child Health Hospital, Shanghai, China
- Jiahao Wu
- International Peace Maternity and Child Health Hospital, Shanghai, China
- Liping Wang
- International Peace Maternity and Child Health Hospital, Shanghai, China
- Benoît Mâsse
- School of Public Health, Université de Montréal, Montreal, Québec, Canada
- Fengxiu Ouyang
- Shanghai Jiaotong University School of Medicine, Shanghai, China
- Yamei Yu
- School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada
- Wenguang Sun
- International Peace Maternity and Child Health Hospital, Shanghai, China
- William Fraser
- Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
- Isabel Fortier
- Research Institute of the McGill University Health Centre, Montreal, Québec, Canada
- Sonia Semenic
- Ingram School of Nursing, McGill University, Montreal, Québec, Canada
- Yanting Wu
- International Peace Maternity and Child Health Hospital, Shanghai, China
- Isabelle Marc
- Department of Pediatrics, Université Laval, Quebec City, Quebec, Canada
- Luigi Bouchard
- Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
- Jianxia Fan
- International Peace Maternity and Child Health Hospital, Shanghai, China
- Peter C K Leung
- The University of British Columbia, Vancouver, British Columbia, Canada
- Xiang Peng Liao
- Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
- C M Herba
- Department of Psychology, Université du Québec à Montréal, Montreal, Québec, Canada
- Linda Booij
- CHU Sainte-Justine Centre de Recherche, Montreal, Québec, Canada
- Antoine Lewin
- Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
- Weibin Wu
- International Peace Maternity and Child Health Hospital, Shanghai, China
- Chen Lei
- International Peace Maternity and Child Health Hospital, Shanghai, China
- Anita Kozyrskyj
- Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada
- N Chaillet
- Department of Pediatrics, Université Laval, Quebec City, Quebec, Canada
- Janelle Zhan
- Unité de Recherche Clinique Appliquée, CHU Sainte-Justine Centre de Recherche, Montreal, Québec, Canada
- Catherine Allard
- Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
- Ma'n Zawati
- Centre of Genomics and Policy, McGill University, Montreal, Québec, Canada
- Jean-Patrice Baillargeon
- Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
- Maria P Velez
- Department of Obstetrics and Gynecology, Queen’s University, Kingston, Ontario, Canada
- Hanqiu Zhang
- International Peace Maternity and Child Health Hospital, Shanghai, China
- Wen Yu
- International Peace Maternity and Child Health Hospital, Shanghai, China
- Caroline Vaillancourt
- Department of Pediatrics, Université Laval, Quebec City, Quebec, Canada
- Han Liu
- International Peace Maternity and Child Health Hospital, Shanghai, China
- Amelie Tetu
- Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
- Wenli Fang
- Changing Maternity and Infant Health Hospital, East China Normal University, Shanghai, China
- Xinzhi Zhao
- International Peace Maternity and Child Health Hospital, Shanghai, China
- Xin-Mei Liu
- International Peace Maternity and Child Health Hospital, Shanghai, China
- Zhirou Chen
- International Peace Maternity and Child Health Hospital, Shanghai, China
- Yan-Hui Hao
- International Peace Maternity and Child Health Hospital, Shanghai, China
- Nadia Abdelouahab
- Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
- DOI
- https://doi.org/10.1136/bmjopen-2020-045192
- Journal volume & issue
-
Vol. 11,
no. 4
Abstract
Introduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number ChiCTR1800017773.Protocol version November 11, 2020 (Version #5).