Dataset Information

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.

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.

SUBMITTER: Li B

PROVIDER: S-EPMC5719318 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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.

Li Bai B Liu Wei Jia WJ Adab Peymane P Pallan Miranda M Hemming Karla K Frew Emma E Lin Rong R Martin James J Liu Wei W Cheng Kar Keung KK

BMJ open 20171201 11

<h4>Introduction</h4>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 eval ...[more]

PMID: 29196485

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Project description:BACKGROUND:In countries undergoing rapid economic transition such as China, rates of increase in childhood obesity exceed that in the West. However, prevention trials in these countries are inadequate in both quantity and methodological quality. In high-income countries, recent reviews have demonstrated that school-based prevention interventions are moderately effective but have some methodological limitations. To address these issues, this study evaluated clinical- and cost- effectiveness of the Chinese Primary School Children Physical Activity and Dietary Behaviour Changes Intervention (CHIRPY DRAGON) developed using the United Kingdom Medical Research Council complex intervention framework to prevent obesity in Chinese primary-school-aged children. METHODS AND FINDINGS:In this cluster-randomised controlled trial, we recruited 40 state-funded primary schools from urban districts of Guangzhou, China. A total of 1,641 year-one children with parent/guardian consent took part in baseline assessments prior to stratified randomisation of schools (intervention arm, 20 schools, n = 832, mean age = 6.15 years, 55.6% boys; control arm n = 809, mean age = 6.14 years, 53.3% boys). The 12-month intervention programme included 4 school- and family-based components delivered by 5 dedicated project staff. We promoted physical activity and healthy eating behaviours through educational and practical workshops, family activities, and supporting the school to improve physical activity and food provision. The primary outcome, assessed blind to allocation, was between-arm difference in body mass index (BMI) z score at completion of the intervention. A range of prespecified, secondary anthropometric, behavioural, and psychosocial outcomes were also measured. We estimated cost effectiveness based on quality-adjusted life years (QALYs), taking a public sector perspective. Attrition was low with 55 children lost to follow up (3.4%) and no school dropout. Implementation adherence was high. Using intention to treat analysis, the mean difference (MD) in BMI z scores (intervention - control) was -0.13 (-0.26 to 0.00, p = 0.048), with the effect being greater in girls (MD = -0.18, -0.32 to -0.05, p = 0.007, p for interaction = 0.015) and in children with overweight or obesity at baseline (MD = -0.49, -0.73 to -0.25, p < 0.001, p for interaction < 0.001). Significant beneficial intervention effects were also observed on consumption of fruit and vegetables, sugar-sweetened beverages and unhealthy snacks, screen-based sedentary behaviour, and physical activity in the intervention group. Cost effectiveness was estimated at £1,760 per QALY, with the probability of the intervention being cost effective compared with usual care being at least 95% at a willingness to pay threshold of £20,000 to 30,000 per QALY. There was no evidence of adverse effects or harms. The main limitations of this study were the use of dietary assessment tools not yet validated for Chinese children and the use of the UK value set to estimate QALYS. CONCLUSIONS:This school- and family-based obesity prevention programme was effective and highly cost effective in reducing BMI z scores in primary-school-aged children in China. Future research should identify strategies to enhance beneficial effects among boys and investigate the transferability of the intervention to other provinces in China and countries that share the same language and cultures. TRIAL REGISTRATION:ISRCTN Identifier ISRCTN11867516.

Project description:BackgroundEconomic evaluation of school-based obesity interventions could provide support for public health decision of obesity prevention. This study is to perform cost-utility and cost-benefit assessment of three school-based childhood obesity interventions including nutrition education intervention (NE), physical activity intervention (PA) and comprehensive intervention (both NE and PA, CNP) with secondary data analysis of one randomized controlled trial.MethodsThe standard cost-effectiveness analysis methods were employed from a societal perspective to the health outcome and costs that are attributable to the intervention. NE, PA and CNP were carried out separately for 2 semesters for childhood obesity interventions in primary schools. The additional quality-adjusted life years (QALYs) resulting from the interventions were measured as the health outcome. A cost-utility ratio (CUR) and A cost-benefit ratio (CBR) was calculated as the ratio of implementation costs to the total medical and productivity loss costs averted by the interventions.ResultsThe CUR and CBR were ¥11,505.9 ($1646.0) per QALY and ¥1.2 benefit per ¥1 cost respectively, and the net saving was ¥73,659.6 ($10,537.9). The CUR and CBR for nutrition education and physical activity interventions were ¥21,316.4 ($3049.6) per QALY and ¥0.7 benefit per ¥1 cost, ¥28,417.1 ($4065.4) per QALY and ¥0.4 benefit per ¥1 cost, respectively (in 2019 RMB). Compared with PA intervention, the ICERs were ¥10,335.2 ($1478.6) and 4626.3 ($661.8) for CNP and NE respectively. The CBR was ¥1.2, 0.7, and 0.4 benefits per ¥1 cost for CNP, NE, and PA interventions, respectively. Net estimated savings were achieved only through CNP intervention, amounting to ¥73,659.6 ($10,537.9).ConclusionsComprehensive school-based obesity intervention is a beneficial investment that is both cost-effective and cost saving. Compared with PA intervention, both CNP and NE intervention were more cost-effective.

Project description:BackgroundAlthough childhood overweight and obesity prevalence has increased substantially worldwide in the past three decades, scarce evidence exists for effective preventive strategies. We aimed to establish whether a school-based intervention for children aged 9-10 years would prevent excessive weight gain after 24 months.MethodsThis pragmatic cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP), a school-based obesity prevention intervention, was done in 32 schools in southwest England. All state-run primary and junior schools in Devon and Plymouth (UK) with enough pupils for at least one year-5 class were eligible. Schools were assigned (1:1) using a computer-generated sequence to either intervention or control, stratified by the number of year-5 classes (one vs more than one) and the proportion of children eligible for free school meals (<19% [the national average] vs ≥19%). HeLP was delivered to year-5 children (ages 9-10 years) over 1 year, and included dynamic and interactive activities such as physical activity workshops, education sessions delivered by teachers with short homework tasks, drama sessions, and setting goals to modify behaviour (with parental support and one-to-one discussions with HeLP coordinators). The primary outcome was change in body-mass index (BMI) standard deviation score (SDS) between baseline and 24 months, analysed in children with BMI data available for both timepoints. This study is registered with the International Standard Randomised Controlled Trial register, number ISRCTN15811706, and the trial status is complete.FindingsBetween March 21, 2012, and Sept 30, 2013, 32 eligible schools with 1324 children were recruited, of which 16 schools (676 children) were randomly assigned to the HeLP intervention and 16 schools (648 children) to control. All schools that began the trial completed the intervention, and 1244 children (628 in intervention group and 616 in control group) had BMI data at both baseline and 24 months for the primary outcome analysis. Mean BMI SDS was 0·32 (SD 1·16) at baseline and 0·35 (1·25) at 24 months in the intervention group, and 0·18 (1·14) at baseline and 0·22 (1·22) at 24 months in the control group. With adjustment for school-level clustering, baseline BMI scores, sex, cohort, and number of year-5 classes and socioeconomic status of each school, the mean difference in BMI SDS score (intervention-control) at 24 months was -0·02 (95% CI -0·09 to 0·05), p=0·57. One parent reported an adverse event related to their child's eating and activity behaviours, but agreed for the child to continue trial participation after discussion with the chief investigator.InterpretationDespite a theoretically informed and extensively piloted intervention that achieved high levels of engagement, follow-up, and fidelity of delivery, we found no effect of the intervention on preventing overweight or obesity. Although schools are an ideal setting in which to deliver population-based interventions, school-based interventions might not be sufficiently intense to affect both the school and the family environment, and hence the weight status of children. Future research should focus on more upstream determinants of obesity and use whole-systems approaches.FundingUK National Institute for Health Research, Public Health Research Programme.

Project description:Childhood obesity is not only associated with adult obesity but also with increased risk of adult onset of type 2 diabetes and subsequent coronary heart disease. The potential effects of school-based health intervention programmes on cardiovascular risk and surrogate markers are unclear, as only few studies have attempted to investigate a complete risk profile including a detailed laboratory analysis or micro- and macrovascular function. In this study a comprehensive school-based randomized intervention programme will be investigated in 10-14-year old children addressing the influence of lifestyle intervention on inactivity, cardiometabolic risk factors and early signs of vascular disease.15 secondary schools in Southern Germany are randomly assigned to intervention or control schools. Children in the fifth grade (10-11 years) will be observed over four years. The study combines a school-based with a home-based approach, aiming at children, teachers and parents. The main components are weekly lifestyle-lessons for children, taught by regular classroom teachers to increase physical activity in- and outside of school, to improve eating patterns at school and at home, to reduce media consumption and to amplify well-being. In 4-6 annual meetings, teachers receive information about health-related topics with worksheets for children and supporting equipment, accounting for school-specific needs and strategies. Parents' trainings are provided on a regular basis.All examinations are performed at the beginning and at the end of every school year. Anthropometry includes measurements of BMI, waist and upper arm circumferences, skinfold thickness as well as peripheral blood pressure. Blood sampling includes lipid parameters, insulin, glucose, hsCRP, adiponectin, and IL-6 as well as testosteron and estrogen to determine maturation status. Vascular function is non-invasively assessed by measuring arterial stiffness in large arteries using a sphygmograph and by analysing arteriolar and venular diameters in the retinal microcirculation using a non-mydriatric vessel analyser. A questionnaire is filled out to determine daily physical activity, motivational factors, dietary habits, quality of life (KINDL-R) and socio-economic data. Physical fitness is assessed by a six-item test battery.Our study aims to provide a feasible long-term intervention strategy to re-establish childhood health and to prevent obesity-related cardiovascular dysfunction in children.NCT00988754.

Project description:The aim of the ACE-Obesity Policy study was to assess the economic credentials of a suite of obesity prevention policies across multiple sectors and areas of governance for the Australian setting. The study aimed to place the cost-effectiveness results within a broad decision-making context by providing an assessment of the key considerations for policy implementation. The Assessing Cost-Effectiveness (ACE) approach to priority-setting was used. Systematic literature reviews were undertaken to assess the evidence of intervention effectiveness on body mass index and/or physical activity for selected interventions. A standardised evaluation framework was used to assess the cost-effectiveness of each intervention compared to a 'no intervention' comparator, from a limited societal perspective. A multi-state life table Markov cohort model was used to estimate the long-term health impacts (quantified as health adjusted life years (HALYs)) and health care cost-savings resulting from each intervention. In addition to the technical cost-effectiveness results, qualitative assessments of implementation considerations were undertaken. All 16 interventions evaluated were found to be cost-effective (using a willingness-to-pay threshold of AUD50,000 per HALY gained). Eleven interventions were dominant (health promoting and cost-saving). The incremental cost-effectiveness ratio for the non-dominant interventions ranged from AUD1,728 to 28,703 per HALY gained. Regulatory interventions tended to rank higher on their cost-effectiveness results, driven by lower implementation costs. However, the program-based policy interventions were generally based on higher quality evidence of intervention effectiveness. This comparative analysis of the economic credentials of obesity prevention policies for Australia indicates that there are a broad range of policies that are likely to be cost-effective, although policy options vary in strength of evidence for effectiveness, affordability, feasibility, acceptability to stakeholders, equity impact and sustainability. Implementation of these policies will require sustained co-ordination across jurisdictions and multiple government sectors in order to generate the predicted health benefits for the Australian population.

Project description:ImportanceA rapid nutritional transition has caused greater childhood obesity prevalence in many countries, but the repertoire of effective preventive interventions remains limited.ObjectiveTo determine the effectiveness of a novel multifaceted intervention for obesity prevention in primary school children.Design, setting, and participantsA cluster randomized clinical trial was conducted during a single school year (from September 11, 2018, to June 30, 2019) across 3 socioeconomically distinct regions in China according to a prespecified trial protocol. Twenty-four schools were randomly allocated (1:1) to the intervention or the control group, with 1392 eligible children aged 8 to 10 years participating. Data from the intent-to-treat population were analyzed from October 1 to December 31, 2019.InterventionsA multifaceted intervention targeted both children (promoting healthy diet and physical activity) and their environment (engaging schools and families to support children's behavioral changes). The intervention was novel in its strengthening of family involvement with the assistance of a smartphone app. The control schools engaged in their usual practices.Main outcomes and measuresThe primary outcome was the change in body mass index (BMI; calculated as weight in kilograms divided by height in square meters) from baseline to the end of the trial. Secondary outcomes included changes in adiposity outcomes (eg, BMI z score, prevalence of obesity), blood pressure, physical activity and dietary behaviors, obesity-related knowledge, and physical fitness. Generalized linear mixed models were used in the analyses.ResultsAmong the 1392 participants (mean [SD] age, 9.6 [0.4] years; 717 boys [51.5%]; mean [SD] BMI, 18.6 [3.7]), 1362 (97.8%) with follow-up data were included in the analyses. From baseline to the end of the trial, the mean BMI decreased in the intervention group, whereas it increased in the control group; the mean between-group difference in BMI change was -0.46 (95% CI, -0.67 to -0.25; P < .001), which showed no evidence of difference across different regions, sexes, maternal education levels, and primary caregivers (parents vs nonparents). The prevalence of obesity decreased by 27.0% of the baseline figure (a relative decrease) in the intervention group, compared with 5.6% in the control group. The intervention also improved other adiposity outcomes, dietary, sedentary, and physical activity behaviors, and obesity-related knowledge, but it did not change moderate- to vigorous-intensity physical activity, physical fitness, or blood pressure. No adverse events were observed during the intervention.Conclusions and relevanceThe multifaceted intervention effectively reduced the mean BMI and obesity prevalence in primary school children across socioeconomically distinct regions in China, suggesting its potential for national scaling.Trial registrationClinicalTrials.gov Identifier: NCT03665857.

Dataset Information

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.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

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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