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
Jun Zhang,
Jian Shen,
Hong Jiang,
Jian Xu,
Louise Mâsse,
Zhong-Cheng Luo,
Lise Dubois,
Bartha Knoppers,
Jiahao Wu,
Liping Wang,
Benoît Mâsse,
Fengxiu Ouyang,
Wenguang Sun,
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
Affiliations
Jun Zhang
MSD R&D (China) Co., Ltd, Beijing, China
Jian Shen
1 Institute of Regulatory Science, China Pharmaceutical University, Nanjing, Jiangsu, China
Hong Jiang
National Integrated Traditional and Western Medicine Center for Cardiovascular Disease, China-Japan Friendship Hospital, Beijing, China
Jian Xu
Department of Rheumatology, First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China
Louise Mâsse
School of Population and Public Health, The University of British Columbia, Vancouver, British Columbia, Canada
Zhong-Cheng Luo
Department of Obstetrics and Gynecology, Lunenfeld-Tanenbaum Research Institute, Prosserman Population Health Center, Mount Sinai Hospital, Institute of Health Policy, Management and Evaluation, Dalla Luna School of Public Health, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
Lise Dubois
School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada
Bartha Knoppers
Centre of Genomics and Policy, McGill University, Montreal, Québec, Canada
Jiahao Wu
International Peace Maternity and Child Health Hospital, Shanghai, China
Liping Wang
Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Benoît Mâsse
Department of Social and Preventive Medicine, Université de Montréal, Montréal, Québec, Canada
Fengxiu Ouyang
Shanghai Jiaotong University School of Medicine, Shanghai, China
Wenguang Sun
International Peace Maternity and Child Health Hospital, Shanghai, China
Isabel Fortier
Maelstrom Research, Research Institute of the McGill University Health Centre, Montreal, Québec, Canada
Sonia Semenic
Ingram School of Nursing, McGill University, Montreal, Québec, Canada
Yanting Wu
Obstetrics and Gynecology Hospital, Institute of Reproduction and Development, Fudan University, Shanghai, China
Isabelle Marc
Department of Pediatrics, CHU de Québec-Université Laval, Quebec City, Québec, 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
Department of Psychiatry, McGill University, Montreal, Québec, Canada
Antoine Lewin
Medical Affairs and Innovation, Héma-Québec, Québec, Montreal and Québec, 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
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).
