Dataset Information

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.

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).

SUBMITTER: Wu Y

PROVIDER: S-EPMC8021741 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature

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Publications

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.

Wu Yanting Y Marc Isabelle I Bouchard Luigi L Ouyang Fengxiu F Luo Zhong-Cheng ZC Fan Jianxia J Dubois Lise L Mâsse Benoît B Zhang Jun J Leung Peter C K PCK Liao Xiang Peng XP Herba C M CM Booij Linda L Shen Jian J Lewin Antoine A Jiang Hong H Wang Liping L Xu Jian J Wu Weibin W Sun Wenguang W Wu Jiahao J Li Hong H Lei Chen C Kozyrskyj Anita A Semenic Sonia S Chaillet N N Fortier Isabel I Masse Louise L Zhan Janelle J Allard Catherine C Knoppers Bartha B Zawati Ma'n M Baillargeon Jean-Patrice JP Velez Maria P MP Zhang Hanqiu H Yu Yamei Y Yu Wen W Ding Yan Y Vaillancourt Caroline C Liu Han H Tetu Amelie A Fang Wenli W Zhang Rong R Zhao Xinzhi X Jin Yan Y Liu Xin-Mei XM Zhang Huijuan H Chen Zhirou Z Yang Xi X Hao Yan-Hui YH Abdelouahab Nadia N Fraser William W Huang He-Feng HF

BMJ open 20210401 4

<h4>Introduction</h4>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.<h4>Methods and analysis</h4>This is a multic ...[more]

PMID: 33795307

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Dataset Information

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.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Protocol version

Publications

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.

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