Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stuart Fairclough

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CHANGE! Protocol V.1.0

Study information

Scientific title

The CHANGE! (Children's Health, Activity and Nutrition: Get Educated!) Project: a clustered randomised controlled trial

Acronym

CHANGE!

Study hypothesis

Participants in the CHANGE! intervention group will accrue more moderate to vigorous physical activity post intervention than the control group.

Ethics approval

Liverpool John Moores Research Ethics Committee approved on 22nd September 2010, reference number 10/ECL/039

Study design

Clustered randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 school’s 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

Phase

Not Applicable

Drug names

Primary outcome measures

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

01/10/2010

Overall trial end date

31/07/2011

Reason abandoned

Eligibility

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

Participant type

Patient

Age group

Child

Gender

Both

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

01/10/2010

Recruitment end date

31/07/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Faculty of Education, Community and Leisure,
Liverpool
L17 6BD
United Kingdom

Sponsor information

Organisation

Liverpool John Moores University (UK)

Sponsor details

Research Support Office
Liverpool John Moores University
c/o Dr. Sue Spiers
Kingsway House
Hatton Garden
Liverpool
L3 2AJ
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Liverpool John Moores University (UK)

Alternative name(s)

LJMU

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Kingdom

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

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22931457
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23819701

Publication citations

  1. Results

    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.

  2. Results

    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.

Editorial Notes