Chinese primary school children physical activity and dietary behaviour changes intervention (CHIRPY DRAGON Study)

ISRCTN	ISRCTN11867516
DOI	https://doi.org/10.1186/ISRCTN11867516
Protocol serial number	N/A
Sponsor	University of Birmingham
Funder	Zhejiang Yong Ning Pharmaceutical Co., Ltd

Submission date: 19/08/2015
Registration date: 25/08/2015
Last edited: 12/09/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
The number of overweight and obese children in cities in China is rapidly increasing, and it is highly likely that these problems will continue into adulthood, leading to serious health problems. Effective ways of preventing and controlling levels of childhood obesity are urgently needed, and a good place to start is with young children who are starting school. An obesity intervention programme including diet changes and exercise was previously tested in children from three schools (http://www.isrctn.com/ISRCTN13619480). The aim of this study is to find out whether implementing this obesity intervention programme across a larger number of schools in Guangzhou city (China) will be cost-effective and successful in tackling the childhood obesity problem.

Who can participate?
Children in their first year of primary school in Guangzhou city (China), their family members and relevant school staff.

What does the study involve?
Forty schools in Guangzhou city in China are selected to take part in the study. These schools are then randomly placed into one of two groups. For schools in the first group (control group) no additional programmes are added to the existing care offered. For schools in the second group (intervention group) the intervention programme will be brought in. The intervention programme consists of four main parts: interactive learning activities to help children and their family members learn more about healthy living, making the meals offered in the schools more healthy and taste better, teaching children and their family members good ways to exercise at home, and finally ensuring that children have to have one hour of physical activity at school every day. The BMI of the children is measured at the start of the study and after one year to compare the amounts of overweight children at both the control and intervention schools.

What are the possible benefits and risks of participating?
Benefits of participating include improved knowledge and parenting/caring skills of parents, grandparents and teachers, as well as improved diet and physical activity habits in children. The stud also promotes quality family time, which is a potential benefit. There are no notable risks in participating.

Where is the study run from?
Participating primary schools in Guangzhou (China)

When is the study starting and how long is it expected to run for?
July 2015 to December 2018

Who is funding the study?
Zhejiang Yong Ning Pharmaceutical Co., Ltd (China)

Who is the main contact?
Dr Bai Li

Contact information

Dr Bai Li
Scientific

Institute of Health and Population Sciences
College of Medical and Dental Sciences
University of Birmingham
Birmingham
B15 2TT
United Kingdom

Study information

Primary study design	Interventional
Study design	Cluster randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Developing and evaluating a theoretically based childhood obesity prevention programme in urban China - A cluster randomised control trial
Study acronym	CHIRPY DRAGON
Study objectives	The study will seek to address the following research questions: 1. How effective is the intervention package in preventing overweight and obesity in children, compared to usual practice? 2. For how long do any observed effects persist, after active intervention has ceased? 3. What is the incremental cost associated with supplying the obesity prevention intervention? 4. What is the incremental benefit associated with supplying the obesity prevention intervention? 5. What is the incremental cost-effectiveness ratio of supplying the obesity prevention intervention? 6. How effective is the intervention package in improving diet and increasing physical activity, compared to usual practice? 7. What is the effect of the intervention on quality of life? 8. Is there a trend in difference in outcomes by sex, social class or baseline BMI?
Ethics approval(s)	University of Birmingham Science, Technology, Engineering and Mathematics Ethical Review Committee, 02/03/2015, ref: ERN_14-1440.
Health condition(s) or problem(s) studied	Childhood overweight/obesity, related health behaviours and quality of life
Intervention	40 urban, non-boarding state primary schools in Guangzhou are selected and randomly assigned into the control arm or the intervention arm. All children who are taking part in the trial will undergo baseline and follow-up measures. Follow-up assessments will take place immediately following the delivery of intervention, and 12 months after the intervention. In addition, parents of participating children will be invited to complete questionnaires at both baseline and follow ups. For schools in the control arm, no additional programmes are added to the existing care offered by the schools. The intervention arm consists of four key components: 1. Improving health knowledge and behaviours among grandparents/parents and children through interactive learning activities 1.1. Interactive learning workshops targeting carers (parents and grandparents) 1.2. Interactive learning workshops targeting children 1.3. Cross-generation quizzes involving both carers and children 1.4. A range of family-wide health behavioural challenges (with self evaluation) , targeting children and their family members 2. Improving the nutritional quality & taste of school meals through 2.1. Introducing feasible school meal improvement objectives (developed by Chinese nutrition experts, child obesity researchers and school catering workers; and tested in the feasibility trial) to catering staff who are responsible for producing meals at intervention schools 2.2. Regular evaluations/monitoring and providing constructive feedback 3. Increasing the level of physical activity outside campus through: 3.1. Family friendly games learned and practiced at schools (attended by both the children and their fathers or mothers) 3.2. Assigning activity home work to all families (i.e. playing the games learnt at school or doing any non-sedentary activities or sports that involve both the child and his/her parents outside school ) 3.3. Completing self-evaluation fun card (this element will be implemented in coordination with component 1’s ‘family-wide health behavioural challenges’). 4. Improving the implementation of the national requirement for ‘One-Hour Physical Activity On Campus Each Day’ in intervention schools through 4.1. Facilitating an initial school internal stakeholders meeting (led by trained project assistants, attended by school leaders, PE teachers, class head teachers and student representatives ) on current situation, barriers and opportunities for improvement (where specific improvement objectives and action plan will be agreed) 4.2. Regular and continuous evaluations/monitoring (by school staff and project assistants) 4.3. Giving monthly constructive feedback (by project assistants) to school stakeholders and setting new objectives and action plan (jointly) for the following month over each follow up meeting.
Intervention type	Behavioural
Primary outcome measure(s)	Current primary outcome meaures: The difference in BMI z-scores (standardised deviation scores) between control and intervention schools at the first follow up, taking into account clustering, baseline levels and other relevant co-variates. Previous primary outcome measures: 1. The difference in BMI z-scores (standardised deviation scores) between control and intervention schools at the first follow up, taking into account clustering, baseline levels and other relevant co-variates. 2. Comparing the percentage of children categorised as overweight and obese in control compared to intervention schools.
Key secondary outcome measure(s)	Current secondary outcome measures as of 01/11/2017: Secondary outcomes are either binary (e.g. physically active vs. inactive), or continuous (e.g. energy expenditure), and therefore either logistic or linear link functions will be used, with transformations where appropriate to accommodate any non-normality. All model assumptions will be checked, goodness of fit explored and models selected using step wise procedures and analysis of deviance. Anthropometric measures (including percentage of overweight and obesity as defined by the WHO 2007 Growth Charts, waist circumference and body fatness). 1. Dietary Assessment: Parents questionnaire and child diary, where several self designed and adapted validated (University of Leeds SFFQ; Day in Life Questionnaire) questionnaires are included. 2. Physical Activity Assessment: Through parents questionnaire, child questionnaire and child diary, self designed questions and adapt validated (Godin Leisure-Time Exercise Questionnaire; Day in Life Questionnaire and PAQ-C) tools will be used to measure physical activity and sedentary behaviours of participating children. Additionally, a validated objective method (GENEActiv Original) will be used to assess physical activity and sedentary behaviours of the children. 3. Process Evaluation: To understand intervention fidelity as well as participants and facilitators’ barriers and facilitators. These will include focus groups and personal interviews with representatives of participants and programme facilitators. Programme facilitators will also be asked to complete a log book on participant attendance, withdrawals, and note any changes or adaptations that they had to make to any sessions, and known reasons. 4. Economic Evaluation: Comparisons will be made between the situation of supplying the intervention package and a situation where no intervention is in existence (i.e. usual current practice). The primary analysis will estimate the cost per Quality-Adjusted Life Year (QALY) using outcomes measured using the CHU9D instrument, a paediatric utility-based QoL measure validated in a Chinese population. The economic evaluation will be conducted from both a public and a societal perspective. The public sector perspective will only include costs linked to delivery of the intervention alongside the average QALY impact on the children; the societal perspective will broaden the framework to include household expenditure and intervention effect on parents and other household adult members. To facilitate this broader perspective, QALYs for parents and other adult household members will be estimated using data collected from the EQ5D instrument. Costs and outcomes will be combined using incremental cost effectiveness ratio (ICER) and expressed as cost per QALY gained. A secondary analysis will conduct a cost-effectiveness analysis using BMI z scores as the outcome in line with the clinical evaluation. The incremental cost-effectiveness ratio for the intervention versus usual practice will thus be ‘cost per change in BMI z score’. Previous secondary outcome measures: Secondary outcomes are either binary (e.g. physically active vs. inactive), or continuous (e.g. energy expenditure), and therefore either logistic or linear link functions will be used, with transformations where appropriate to accommodate any non-normality. All model assumptions will be checked, goodness of fit explored and models selected using step wise procedures and analysis of deviance. 1. Dietary Assessment: Parents questionnaire and child diary, where several self designed and adapted validated (University of Leeds SFFQ; Day in Life Questionnaire) questionnaires are included. 2. Physical Activity Assessment: Through parents questionnaire, child questionnaire and child diary, self designed questions and adapt validated (Godin Leisure-Time Exercise Questionnaire; Day in Life Questionnaire and PAQ-C) tools will be used to measure physical activity and sedentary behaviours of participating children. Additionally, a validated objective method (GENEActiv Original) will be used to assess physical activity and sedentary behaviours of the children. 3. Process Evaluation: To understand intervention fidelity as well as participants and facilitators’ barriers and facilitators. These will include focus groups and personal interviews with representatives of participants and programme facilitators. Programme facilitators will also be asked to complete a log book on participant attendance, withdrawals, and note any changes or adaptations that they had to make to any sessions, and known reasons. 4. Economic Evaluation: Comparisons between the situation of supplying the intervention package and a situation where no intervention is in existence (i.e. usual current practice) to estimate the cost per Quality-Adjusted Life Year (QALY) using outcomes measured using the CHU9D instrument, a paediatric utility-based QoL measure validated in a Chinese population.
Completion date	31/12/2018

Eligibility

Participant type(s)	Mixed
Age group	Mixed
Sex	All
Target sample size at registration	1600
Total final enrolment	1641
Key inclusion criteria	1. First year students (aged 6–7) from non-boarding state primary schools in Guangzhou city (China) 2. Students' family members 3. Relevant school staff
Key exclusion criteria	Children: 1. Not from randomly selected schools 2. No parental consent given
Date of first enrolment	01/09/2015
Date of final enrolment	30/09/2015

Locations

Countries of recruitment

China

Study participating centre

Participating primary schools in Guangzhou, China

n/a
China

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	Data are available upon request by contacting the first author but are not publicly available due to our ethical permissions. Re-analysis and secondary analysis will need to be within the original remit of the research question and will need to be approved by the research team in advance of sharing the dataset.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	26/11/2019	27/11/2019	Yes	No
Protocol article		01/12/2017		Yes	No
Other publications	An assessment of the construct validity	26/08/2021	12/09/2023	Yes	No
Other publications	Cost effectiveness	25/08/2021	12/09/2023	Yes	No

Editorial Notes

12/09/2023: Publication references added.
27/11/2019: Publication reference and total final enrolment number added.
13/12/2017: Publication reference and IPD sharing statement added. Participant level data was changed from not expected to made available to available upon request.
01/11/2017: The outcome measures have been updated. The target number of participants have been updated from and average class size of 45 instead of 40, therefore the target number of participants is around 1600. The intention to publish date has been updated form 01/12/2015 to 01/12/2018.
21/01/2016: Internal review