Dataset Information

Effectiveness of a Multifaceted Intervention for Prevention of Obesity in Primary School Children in China: A Cluster Randomized Clinical Trial.

ABSTRACT:

Importance

A rapid nutritional transition has caused greater childhood obesity prevalence in many countries, but the repertoire of effective preventive interventions remains limited.

Objective

To determine the effectiveness of a novel multifaceted intervention for obesity prevention in primary school children.

Design, setting, and participants

A 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.

Interventions

A 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 measures

The 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.

Results

Among 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 relevance

The 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 registration

ClinicalTrials.gov Identifier: NCT03665857.

SUBMITTER: Liu Z

PROVIDER: S-EPMC8576631 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effectiveness of a Multifaceted Intervention for Prevention of Obesity in Primary School Children in China: A Cluster Randomized Clinical Trial.

Liu Zheng Z Gao Pei P Gao Ai-Yu AY Lin Yi Y Feng Xiang-Xian XX Zhang Fang F Xu Li-Qun LQ Niu Wen-Yi WY Fang Hai H Zhou Shuang S Li Wen-Hao WH Yuan Jian-Hui JH Xu Chun-Xia CX Wu Na N Li Hui-Juan HJ Wen Li-Ming LM Patton George C GC Wang Hai-Jun HJ Wu Yang-Feng YF

JAMA pediatrics 20220104 1

<h4>Importance</h4>A rapid nutritional transition has caused greater childhood obesity prevalence in many countries, but the repertoire of effective preventive interventions remains limited.<h4>Objective</h4>To determine the effectiveness of a novel multifaceted intervention for obesity prevention in primary school children.<h4>Design, setting, and participants</h4>A cluster randomized clinical trial was conducted during a single school year (from September 11, 2018, to June 30, 2019) across 3 s ...[more]

PMID: 34747972

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Project description:IntroductionChildhood 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 analysisA 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 disseminationEthical 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 numberISRCTN11867516; Pre-results.

Project description:BackgroundIn 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 findingsIn 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.ConclusionsThis 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 registrationISRCTN Identifier ISRCTN11867516.

Project description:Evidence of the effectiveness of intervention against extreme heat remains unclear, especially among children, one of the vulnerable populations. This study aimed to evaluate the effectiveness of a primary school-based intervention program against heatwave and climate change in China to provide evidence for development of policies for adaptation to climate change. Two primary schools in Dongtai City, Jiangsu Province, China, were randomly selected as intervention and control schools (CTR registration number: ChiCTR2200056005). Health education was conducted at the intervention school to raise students' awareness and capability to respond to extreme heat during May to September in 2017. Knowledge, attitude, and practice (KAP) of students and their parents at both schools were investigated by questionnaire surveys before and after intervention. The changes in KAP scores after intervention were evaluated using multivariable difference-in-difference (DID) analysis, controlling for age, sex, etc. Results: The scores of knowledge, attitude, and practice of students and their parents increased by 19.9% (95%CI: 16.3%, 23.6%) and 22.5% (95%CI: 17.8%, 27.1%); 9.60% (95%CI: 5.35%, 13.9%) and 7.22% (95%CI: 0.96%, 13.5%); and 9.94% (95%CI: 8.26%, 18.3%) and 5.22% (95%CI: 0.73%, 9.71%), respectively, after intervention. The KAP score changes of boys were slightly higher than those of girls. Older students had higher score changes than younger students. For parents, the higher the education level, the greater the score change, and change in scores was greater in females than in males. All the health education activities in the program were significantly correlated with the changes in KAP scores of primary school students after intervention, especially those curricula with interesting activities and experiential learning approaches. Heat and health education program in primary school was an effective approach to improve cognition and behavior for both students and their parents to better adapt to heatwaves and climate change. The successful experience can be generalized to respond to the increasing extreme weather/climate events in the context of climate change, such as heatwaves, and other emergent occasions or public health education, such as the control and prevention of COVID-19.

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:BackgroundChildhood obesity has been a serious public health problem. An effective school-based physical activity (PA) intervention is still lacking in China. This study aimed to assess the effectiveness of a school-based physical activity intervention during 12 weeks on obesity and related health outcomes in school children.MethodsIt was a non-randomized controlled trial. Altogether 921 children aged 7 to 15 years were recruited at baseline survey. Children in the intervention group (n = 388) participated in a multi-component physical activity intervention during 12 weeks that included improvement of physical education, extracurricular physical activities for overweight/obese students, physical activities at home, and health education lectures for students and parents. Children (n = 533) in the control group participated in usual practice.ResultsParticipants had mean age of 10.4 years, mean body mass index (BMI) of 19.59 kg/m2, and 36.8 % of them were overweight or obese at baseline survey. The change in BMI in intervention group (-0.02 ± 0.06 kg/m2) was significantly different from that in control group (0.41 ± 0.08 kg/m2). The adjusted mean difference was -0.43 kg/m2 (95% CI: -0.63 to -0.23 kg/m2, P < 0.001). The effects on triceps, subscapular, abdominal skinfold thickness and fasting glucose were also significant in intervention group compared with control group (all P < 0.05). The change in duration of moderate to vigorous physical activity (MVPA) in intervention group (8.9 ± 4.3 min/day) was significantly different from that in control group (-13.8 ± 3.3 min/day). The adjusted mean difference was 22.7 min/day (95% CI: 12.2 to 33.2 min/day, P < 0.001).ConclusionsThe school-based, multi-component physical activity intervention was effective to decreasing levels of BMI, skinfold thickness, fasting glucose and increasing duration of MVPA. These findings provided evidence for the development of effective and feasible school-based obesity interventions.Trial registrationClinicaltrials.gov Identifier: NCT02074332 (2014-02-26).

Project description:BackgroundChildhood obesity has been increasing rapidly worldwide. There is limited evidence for effective lifestyle interventions to prevent childhood obesity worldwide, especially in developing countries like China. The objective of this study was to assess the effectiveness of a school-based multi-component lifestyle childhood obesity prevention program (the CLICK-Obesity study) in Mainland China.MethodsA cluster randomized controlled trial was developed among grade 4 students from 8 urban primary schools (638 students in intervention, 544 as control) in Nanjing City, China. Students were randomly allocated to the control or intervention group at school-level. A one-year multi-component intervention program (classroom curriculum, school environment support, family involvement and fun programs/events) together with routine health education was provided to the intervention group, while the control group received routine health education only. The main outcome variables assessed were changes in body mass index, obesity occurrence, obesity-related lifestyle behaviors and knowledge.ResultsOverall, 1108 (93.7%) of the 1182 enrolled students completed the intervention study. The intervention group had a larger marginal reduction than did the control group in overall mean BMI value (-0.32±1.36 vs. -0.29±1.40, p = 0.09), although this was not significant. Compared with the control group, the intervention group was more likely to decrease their BMI (OR = 1.44, 95%CI = 1.10, 1.87) by 0.5 kg/m2 or above, increase the frequency of jogging/running (OR = 1.55, 95%CI = 1.18, 2.02), decrease the frequency of TV/computer use (OR = 1.41, 95%CI = 1.09, 1.84) and of red meat consumption (OR = 1.50, 95%CI = 1.15, 1.95), change commuting mode to/from school from sedentary to active mode (OR = 2.24, 95%CI = 1.47, 3.40), and be aware of the harm of selected obesity risk factors.ConclusionsThe school-based lifestyle intervention program was practical and effective in improving health behaviors and obesity-related knowledge for children in China. This study provides important policy implications on school-based intervention programs for modifications of obesity-related lifestyles.Trial registrationChinese Clinical Trial Registry ChiCTR-ERC-11001819.

Project description:ObjectiveWe aimed to investigate the associations between school-level characteristics and obesity among Chinese primary school children with consideration of individual-level characteristics.DesignThis cross-sectional study was conducted in 2015/2016. School-level characteristics were assessed using an interviewer-administered school questionnaire, and a 'school-based obesity prevention index' was further developed. Individual-level characteristics were collected by self-administered questionnaires. Objectively measured height and weight of students were collected, and obesity status was classified according to the International Obesity Task Force criteria for Asian children. Generalised linear mixed models were used to estimate the associations among the school- and individual-level characteristics and obesity of students.SettingThirty-seven primary schools from an urban and a rural district of Beijing, China.ParticipantsSchool staffs, 2201 students and their parents.ResultsThe school-based obesity prevention index involved the number of health professionals, availability of students' health records, monitoring students' nutrition status, frequency of health education activities, reporting achievements of obesity prevention activities to parents, duration of physical activity during school time and availability of playground equipment. The prevalence of obesity was lower in schools with the higher index value compared with that in schools with the lower index value (OR 0·56; 95 % CI 0·40, 0·79). Some individual-level characteristics were negatively associated with childhood obesity: liking sports, duration of screen time ≤2 h/d, perceived lower eating speed, parental non-overweight/obesity.ConclusionsIrrespective of individual-level characteristics, the specific school-level characteristics had a cumulative effect on obesity among Chinese primary school children. Further school-based obesity intervention should consider these characteristics simultaneously.

Project description:BackgroundThe prevalence of mental health problems in childhood and adolescence has increased significantly, not least due to the COVID-19 pandemic in Germany and other countries worldwide. Although holistic school interventions to promote mental health and prevent mental health problems are considered promising, there is currently uncertainty about their effectiveness due to evaluation studies with heterogeneous methodological quality. This paper presents the study protocol for the evaluation of the primary school module of MindMatters.MethodsAs part of a universal mental health intervention, the MindMatters primary school module 'Learning Together with Emotions' aims to promote social-emotional learning (SEL) in the classroom across five skill areas. In addition to classroom activities, the intervention includes a school development module to help primary schools create structures and processes to maintain and promote mental health. To evaluate the effectiveness of the intervention, a two-arm cluster-randomised controlled trial will be conducted, including schools implementing MindMatters over a 12-month period and a control group with no access to the intervention. Data will be collected before and 18 months after initiation of the intervention. Controlled for baseline conditions, multilevel regression analysis will be used to examine primary intervention outcomes at the pupil level (i.e. reductions in mental and behavioural problems). Further mediation and moderation analyses will examine whether proximal outcomes predict changes in mental health outcomes and whether school-level factors influence the effectiveness of the intervention.DiscussionThis study will contribute to strengthen the evidence base for holistic school (mental) health promotion interventions using a study design with high internal validity. Based on an intervention model, the results will not only provide insights into the relationship between proximal and distal outcomes, but will also allow conclusions to be drawn about how the implementation of the intervention affects its effectiveness. Finally, the findings also address the question of whether improved mental health has a positive effect on primary school pupils' academic performance.Trial registrationGerman Clinical Trials Register DRKS00023762. Registered on 5 January 2021.

Dataset Information

Effectiveness of a Multifaceted Intervention for Prevention of Obesity in Primary School Children in China: A Cluster Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Effectiveness of a Multifaceted Intervention for Prevention of Obesity in Primary School Children in China: A Cluster Randomized Clinical Trial.

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