Condition category
Nutritional, Metabolic, Endocrine
Date applied
09/01/2015
Date assigned
03/02/2015
Last edited
20/01/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

www.bham.ac.uk

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

Publication citations

Additional files

Editorial Notes