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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: 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, a...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8021741/
https://www.ncbi.nlm.nih.gov/pubmed/33795307
http://dx.doi.org/10.1136/bmjopen-2020-045192
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author 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
author_facet 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
author_sort Wu, Yanting
collection PubMed
description 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).
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spelling pubmed-80217412021-04-21 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 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 BMJ Open Obstetrics and Gynaecology 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). BMJ Publishing Group 2021-04-01 /pmc/articles/PMC8021741/ /pubmed/33795307 http://dx.doi.org/10.1136/bmjopen-2020-045192 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Obstetrics and Gynaecology
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
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Obstetrics and Gynaecology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8021741/
https://www.ncbi.nlm.nih.gov/pubmed/33795307
http://dx.doi.org/10.1136/bmjopen-2020-045192
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