Plain English Summary
Background and study aims
The number of children who are overweight and obese in urban China is increasing rapidly and there is a high likelihood that these problems will persist in adulthood and affect health. Effective interventions to prevent and control childhood obesity are urgently needed. The aim of this study is to test an obesity prevention programme among urban primary school children in Guangzhou (China).
Who can participate?
Students aged 6–7 and their family members, and relevant school staff
What does the study involve?
Children and their family members will be randomly selected from participating schools.
What are the possible benefits and risks of participating?
A benefit is the prevention of obesity and its consequences. Risks were not provided at the time of registration.
Where is the study run from?
Three non-boarding state primary schools in Guangzhou (China)
When is the study starting and how long is it expected to run for?
From March 2015 to July 2015
Who is funding the study?
Zhejiang Yong Ning Pharmaceutical Co Ltd
Who is the main contact?
Dr Bai Li
b.li.3@bham.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Bai Li
ORCID ID
Contact details
Department of Public Health
Epidemiology and Biostatistics
School of Health and Population Sciences
College of Medical and Dental Sciences
University of Birmingham
Birmingham
B15 2TT
United Kingdom
+44 1214147365
b.li.3@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
-
Study information
Scientific title
Development and evaluation of a childhood obesity prevention programme in urban China: a feasibility trial
Acronym
CHIRPY DRAGON
Study hypothesis
1. Are the planned methods for the recruitment of school and participants feasible?
2. Is delivery of the developed intervention programmes feasible?
3. Are the planned methods and procedures for outcome measures feasible?
4. What modifications in intervention components and/or implementation arrangements are needed to maximise the programme's feasibility and acceptability?
5. What are the most culturally relevant methods for cost-effectiveness evaluation for a future trial?
Ethics approval
University of Birmingham Science, Technology, Engineering and Mathematics Ethical Review Committee, 16/12/2014, reference number ERN_14-1440
Study design
Feasibility study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Schools
Trial type
Prevention
Patient information sheet
Condition
Childhood overweight or obesity, related health behaviours and quality of life
Intervention
Four components:
1. Improving health knowledge and perception among grandparents or parents and children through:
1.1. Interactive learning activities targeting carers
1.2. Interactive learning activities targeting children
1.3. Cross-generation quizzes targeting both carers and children
1.4. Family-wide health behavioural challenges targeting both carers and children
2. Improving the nutritional quality and taste of school meals and parental perception about school meals by:
2.1. Having a joint monitoring and evaluating system
2.2. Demonstrating tested and feasible changes to current menus and preparation methods among kitchen staff
3. Providing and encouraging off-campus physical activities that involve both parents and children by:
3.1. Demonstrating and practicing family-friendly active fun games
3.2. Assigning homework to play the games learnt once a day outside school (this homework will be implemented in coordination with component 1.4.)
4. Promoting better implementation of the national requirement for a 1 hour of physical activity on campus each day in schools by:
4.1. Facilitating discussion about situation, barriers and opportunities for improvement
4. 2. Supporting continuous development of action plan and progress evaluation
Activities in components 1 and 3 will take place once every 2 weeks for a total of three or four sessions in the spring term (family-wide health behavioural challenges will be on a weekly basis); activities in components 2 and 4 will take place mostly on a daily or weekly basis.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
Body-mass index z score at baseline
Secondary outcome measures
1. Children’s quality of life, assessed with the validated Chinese version of the Pediatric Quality of Life Inventory (4.0) and the validated Chinese version of the Child Health Utility 9D; both will be administered to children face to face by a trained researcher
2. Child diet, assessed with an adapted Short Form Food Frequency Questionnaire
3. Physical activity, assessed with the Zhiji Energy Monitor UX-02, a translated version of the Day in Life Questionnaire, an adapted version of the Physical Activity Questionnaire for Older Children, and an adapted version of the Godin Leisure-Time Exercise Questionnaire and self-designed questions
4. Quality of life of parents and grandparents, assessed with the Chinese version of EQ-5D
The outcome measures will be tested at baseline.
Overall trial start date
01/01/2014
Overall trial end date
31/12/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. First year students (aged 6–7) in three non-boarding state primary schools in Guangzhou (China)
2. Students' family members
3. Relevant school staff
Participant type
Mixed
Age group
Mixed
Gender
Both
Target number of participants
123 for testing outcome measures
Participant exclusion criteria
Students who are not in year one of the three participating schools and their family members
Recruitment start date
09/02/2015
Recruitment end date
20/03/2015
Locations
Countries of recruitment
China
Trial participating centre
Three non-boarding state primary schools in Guangzhou (China)
Guangzhou
China
Sponsor information
Organisation
University of Birmingham
Sponsor details
Edgbaston
Birmingham
B15 2TT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Zhejiang Yong Ning Pharmaceutical Co., Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
1. Submission of articles reporting on intervention development (methods and results of the theoretical modelling phase and feasibility study) and the protocol for the randomised controlled trial to peer reviewed journals
2. Presentation at relevant international conferences
3. Preparation of reports in plain Chinese after completion of the feasibility study and dissemination to local authorities, schools, participants' families, and the funder; if required, reports will also be made available in English
4. Findings from the study that have implications for other members of the wider community will be publicised through the mass media
Intention to publish date
01/09/2015
Participant level data
Not expected to be available
Results - basic reporting
Publication summary