The CHANGE! (Children's Health, Activity and Nutrition: Get Educated!) Project

ISRCTN	ISRCTN03863885
DOI	https://doi.org/10.1186/ISRCTN03863885
Protocol serial number	CHANGE! Protocol V.1.0
Sponsor	Liverpool John Moores University (UK)
Funder	Liverpool John Moores University (UK)

Submission date: 16/02/2011
Registration date: 17/03/2011
Last edited: 16/08/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stuart Fairclough
Scientific

Faculty of Education, Community and Leisure
Liverpool John Moores University
IM Marsh Campus
Barkhill Road
Liverpool
L17 6BD
United Kingdom

Study information

Primary study design	Interventional
Study design	Clustered randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The CHANGE! (Children's Health, Activity and Nutrition: Get Educated!) Project: a clustered randomised controlled trial
Study acronym	CHANGE!
Study objectives	Participants in the CHANGE! intervention group will accrue more moderate to vigorous physical activity post intervention than the control group.
Ethics approval(s)	Liverpool John Moores Research Ethics Committee approved on 22nd September 2010, reference number 10/ECL/039
Health condition(s) or problem(s) studied	Paediatric health, physical activity, exercise science and nutrition disciplines
Intervention	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.
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/07/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	300
Key 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
Key exclusion criteria	Children without parental consent, participant assent or those with a medical condition that precluded them from taking part in the programme
Date of first enrolment	01/10/2010
Date of final enrolment	31/07/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Faculty of Education, Community and Leisure,

Liverpool
L17 6BD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	29/08/2012		Yes	No
Results article	results	02/07/2013		Yes	No
Results article	results	24/07/2018		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

16/08/2018: Publication reference added.