Cluster-randomised controlled trial to assess the effectiveness and cost-effectiveness of an obesity prevention programme for Chinese primary school-aged children: the CHIRPY DRAGON study protocol

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Abstract

Introduction

Childhood obesity in China has increased more rapidly and over a shorter time period than in other countries. However, there is a paucity of rigorously developed and evaluated prevention interventions. We aim to evaluate the clinical and cost-effectiveness as well as the implementation process of a complex multicomponent intervention developed using the UK Medical Research Council (MRC) framework. This study provides one of the first examples of rigorous development and evaluation of a childhood obesity prevention programme in a non-western population using the MRC methods.

Methods and analysis

A cluster-randomised controlled trial in 40 primary schools in Guangzhou, China, including children aged 6–7 years at baseline. Schools will be randomly allocated to either the usual practice (n=20) or intervention arm (n=20). The 12-month intervention consists of four components targeting diet and physical activity behaviours in and outside school, with family involvement. The primary objective is to compare the difference in mean body mass index (BMI) z-score between the intervention and control arms at the end of the intervention (starting March/April 2017). A sample size of 1640 pupils recruited from 40 schools is sufficient to detect a difference of 0.17 units in the mean BMI z-score with a power of 80% (ICC=0.01. ICC, intraclass correlation coefficient) and a significance level of 5%. Treatment effects will be tested using a mixed linear model in STATA adjusting for the child baseline BMI z-score and clustering by school. All analyses will be by intention to treat. Secondary analyses will additionally adjust for prespecified school-level and child-level covariates. The incremental cost-effectiveness ratio for the intervention versus usual practice will be ‘cost per quality-adjusted life year (QALY)’. Cost per change in BMI z-score will also be assessed. A range of methods will be used to evaluate intervention implementation, mechanisms of impact and contextual factors.

Ethics and dissemination

Ethical approval was obtained from the Life and Health Sciences Ethical Review Committee at the University of Birmingham and the Ethical Committee of Guangzhou Centre for Disease Control and Prevention. The primary, secondary, process evaluation and economic evaluation results of the trial will be disseminated through relevant international peer-reviewed journals and conferences.

Trial registration number

ISRCTN11867516; Pre-results.

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Most cited references 28

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Interventions for preventing obesity in children.

Elizabeth Waters, Andrea M de Silva-Sanigorski, Belinda Hall … (2011)

Prevention of childhood obesity is an international public health priority given the significant impact of obesity on acute and chronic diseases, general health, development and well-being. The international evidence base for strategies that governments, communities and families can implement to prevent obesity, and promote health, has been accumulating but remains unclear. This review primarily aims to update the previous Cochrane review of childhood obesity prevention research and determine the effectiveness of evaluated interventions intended to prevent obesity in children, assessed by change in Body Mass Index (BMI). Secondary aims were to examine the characteristics of the programs and strategies to answer the questions "What works for whom, why and for what cost?" The searches were re-run in CENTRAL, MEDLINE, EMBASE, PsychINFO and CINAHL in March 2010 and searched relevant websites. Non-English language papers were included and experts were contacted. The review includes data from childhood obesity prevention studies that used a controlled study design (with or without randomisation). Studies were included if they evaluated interventions, policies or programs in place for twelve weeks or more. If studies were randomised at a cluster level, 6 clusters were required. Two review authors independently extracted data and assessed the risk of bias of included studies. Data was extracted on intervention implementation, cost, equity and outcomes. Outcome measures were grouped according to whether they measured adiposity, physical activity (PA)-related behaviours or diet-related behaviours. Adverse outcomes were recorded. A meta-analysis was conducted using available BMI or standardised BMI (zBMI) score data with subgroup analysis by age group (0-5, 6-12, 13-18 years, corresponding to stages of developmental and childhood settings). This review includes 55 studies (an additional 36 studies found for this update). The majority of studies targeted children aged 6-12 years. The meta-analysis included 37 studies of 27,946 children and demonstrated that programmes were effective at reducing adiposity, although not all individual interventions were effective, and there was a high level of observed heterogeneity (I(2)=82%). Overall, children in the intervention group had a standardised mean difference in adiposity (measured as BMI or zBMI) of -0.15kg/m(2) (95% confidence interval (CI): -0.21 to -0.09). Intervention effects by age subgroups were -0.26kg/m(2) (95% CI:-0.53 to 0.00) (0-5 years), -0.15kg/m(2) (95% CI -0.23 to -0.08) (6-12 years), and -0.09kg/m(2) (95% CI -0.20 to 0.03) (13-18 years). Heterogeneity was apparent in all three age groups and could not explained by randomisation status or the type, duration or setting of the intervention. Only eight studies reported on adverse effects and no evidence of adverse outcomes such as unhealthy dieting practices, increased prevalence of underweight or body image sensitivities was found. Interventions did not appear to increase health inequalities although this was examined in fewer studies. We found strong evidence to support beneficial effects of child obesity prevention programmes on BMI, particularly for programmes targeted to children aged six to 12 years. However, given the unexplained heterogeneity and the likelihood of small study bias, these findings must be interpreted cautiously. A broad range of programme components were used in these studies and whilst it is not possible to distinguish which of these components contributed most to the beneficial effects observed, our synthesis indicates the following to be promising policies and strategies:· school curriculum that includes healthy eating, physical activity and body image· increased sessions for physical activity and the development of fundamental movement skills throughout the school week· improvements in nutritional quality of the food supply in schools· environments and cultural practices that support children eating healthier foods and being active throughout each day· support for teachers and other staff to implement health promotion strategies and activities (e.g. professional development, capacity building activities)· parent support and home activities that encourage children to be more active, eat more nutritious foods and spend less time in screen based activitiesHowever, study and evaluation designs need to be strengthened, and reporting extended to capture process and implementation factors, outcomes in relation to measures of equity, longer term outcomes, potential harms and costs.Childhood obesity prevention research must now move towards identifying how effective intervention components can be embedded within health, education and care systems and achieve long term sustainable impacts.

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Worldwide trends in childhood overweight and obesity.

Youfa Wang, Tim Lobstein (2005)

Obesity has become a global epidemic but our understanding of the problem in children is limited due to lack of comparable representative data from different countries, and varying criteria for defining obesity. This paper summarises the available information on recent trends in child overweight and obesity prevalence. PubMed was searched for data relating to trends over time, in papers published between January 1980 and October 2005. Additional studies identified by citations in retrieved papers and by consultation with experts were included. Data for trends over time were found for school-age populations in 25 countries and for pre-school populations in 42 countries. Using these reports, and data collected for the World Health Organization's Burden of Disease Program, we estimated the global prevalence of overweight and obesity among school-age children for 2006 and likely prevalence levels for 2010. The prevalence of childhood overweight has increased in almost all countries for which data are available. Exceptions are found among school-age children in Russia and to some extent Poland during the 1990s. Exceptions are also found among infant and pre-school children in some lower-income countries. Obesity and overweight has increased more dramatically in economically developed countries and in urbanized populations. There is a growing global childhood obesity epidemic, with a large variation in secular trends across countries. Effective programs and policies are needed at global, regional and national levels to limit the problem among children.

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Do obese children become obese adults? A review of the literature.

M.K. Serdula, D Ivery, R.J. Coates … (1993)

Obese children may be at increased risk of becoming obese adults. To examine the relationship between obesity in childhood and obesity in adulthood, we reviewed the epidemiologic literature published between 1970 and July 1992. Comparison between studies was complicated by differences in study design, definitions of obesity, and analytic methods used. Although the correlations between anthropometric measures of obesity in childhood and those in adulthood varied considerably among studies, the associations were consistently positive. About a third (26 to 41%) of obese preschool children were obese as adults, and about half (42 to 63%) of obese school-age children were obese as adults. For all studies and across all ages, the risk of adult obesity was at least twice as high for obese children as for nonobese children. The risk of adult obesity was greater for children who were at higher levels of obesity and for children who were obese at older ages. The wide range of estimates in this literature are, in part, due to differences in study designs, definitions of obesity, ages at which participants were measured, intervals between measurements, and population and cultural differences.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2017

Publication date (Electronic): 1 December 2017

Volume: 7

Issue: 11

Electronic Location Identifier: e018415

Affiliations

[1 ] departmentInstitute of Applied Health Research , College of Medical and Dental Sciences, University of Birmingham , Birmingham, UK

[2 ] departmentFaculty of School Health , Guangzhou Centre for Disease Control and Prevention , Guangzhou, PR China

Author notes

[Correspondence to ] Professor Peymane Adab; p.adab@ 123456bham.ac.uk

Article

Publisher ID: bmjopen-2017-018415

DOI: 10.1136/bmjopen-2017-018415

PMC ID: 5719318

PubMed ID: 29196485

SO-VID: 56cd64c9-b628-4f9d-a7db-9db9365a260e

License:

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 and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

History

Date received : 03 July 2017

Date revision received : 09 October 2017

Date accepted : 18 October 2017

Funding

Funded by: Charitable donation to the University of Birmingham by Zhejiang Yong Ning Pharmaceutical Ltd Co.;

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ScienceOpen disciplines: Medicine

Keywords: childhood obesity prevention,process evaluation,cost-effectiveness,cluster-randomised controlled trial,chinese children,behavioural change technique

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ScienceOpen disciplines: Medicine

Keywords: childhood obesity prevention, process evaluation, cost-effectiveness, cluster-randomised controlled trial, chinese children, behavioural change technique

Cluster-randomised controlled trial to assess the effectiveness and cost-effectiveness of an obesity prevention programme for Chinese primary school-aged children: the CHIRPY DRAGON study protocol

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Abstract

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

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Point-of-Care Testing for Infectious Diseases Super Collection

Most cited references 28

Interventions for preventing obesity in children.

Worldwide trends in childhood overweight and obesity.

Do obese children become obese adults? A review of the literature.

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