CHANGE! Protocol V.1.0
The CHANGE! (Children's Health, Activity and Nutrition: Get Educated!) Project: a clustered randomised controlled trial
Participants in the CHANGE! intervention group will accrue more moderate to vigorous physical activity post intervention than the control group.
Liverpool John Moores Research Ethics Committee approved on 22nd September 2010, reference number 10/ECL/039
Clustered randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Paediatric health, physical activity, exercise science and nutrition disciplines
The CHANGE! pilot study is a clustered randomised controlled trial (RCT) investigating the efficacy of a twenty lesson school-based physical activity and healthy eating intervention. CHANGE! is delivered through the Personal and Social Health Education strand of schools curricula and the curriculum resource is supplemented by homework tasks that target family involvement.
Twelve schools from the Wigan Borough in North-West England were recruited to the study, Six randomly assigned using a random number generator to the intervention condition. Randomisation occurred prior to baseline measures. Class teachers from the intervention schools received training in the curriculum resource over two twilight training sessions, and were fully familiarised with the CHANGE! curriculum prior to implementation. CHANGE! consists of 20 lesson plans, including worksheets and other resources. This curriculum resource is supplemented by homework tasks that target family involvement. Control schools will receive the curriculum and training in the following academic year once the study has been completed. Measures were completed for intervention and control groups at baseline and will be repeated post-intervention (20 weeks) and at 30-32 weeks follow up, prior to the school summer holidays.
Primary outcome measure
Levels of habitual physical activity, moderate to vigorous physical activity (MVPA)-outcome measured at baseline and will be repeated post-intervention (20 weeks) and at 30-32 weeks follow up, prior to the school summer holidays.
Secondary outcome measures
1. Anthropometrics and body composition
2. Cardiorespiratory fitness
3. Food intake
4. Eating behaviour and knowledge
5. Physical self-perceptions
6. Family nutrition and physical activity
7. Behaviour change
8. Quality of life
9. Cardiometabolic disease risk markers
10. Fundamental movement skills
Outcomes were measured at baseline and will be repeated post-intervention (20 weeks) and at 30-32 weeks follow up, prior to the school summer holidays.
To reduce ionising radiation dosage, DEXA body composition scans will be conducted at baseline and follow-up only.
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
Within the twelve participating schools:
1. All year 6 children were invited to take part
2. All children with informed parental consent, participant assent and medical screening were eligible to take part
Target number of participants
Three-hundred 10-11.9yr old children
Participant exclusion criteria
Children without parental consent, participant assent or those with a medical condition that precluded them from taking part in the programme
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Faculty of Education, Community and Leisure,
Liverpool John Moores University (UK)
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Boddy LM, Knowles ZR, Davies IG, Warburton GL, Mackintosh KA, Houghton L, Fairclough SJ, Using formative research to develop the healthy eating component of the CHANGE! school-based curriculum intervention., BMC Public Health, 2012, 12, 710, doi: 10.1186/1471-2458-12-710.
Fairclough SJ, Hackett AF, Davies IG, Gobbi R, Mackintosh KA, Warburton GL, Stratton G, van Sluijs EM, Boddy LM, Promoting healthy weight in primary school children through physical activity and nutrition education: a pragmatic evaluation of the CHANGE! randomised intervention study., BMC Public Health, 2013, 13, 626, doi: 10.1186/1471-2458-13-626.