The CHANGE! (Children's Health, Activity and Nutrition: Get Educated!) Project
| ISRCTN | ISRCTN03863885 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03863885 |
| Secondary identifying numbers | CHANGE! Protocol V.1.0 |
- 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
- Not Applicable
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Stuart Fairclough
Scientific
Scientific
Faculty of Education, Community and Leisure
Liverpool John Moores University
IM Marsh Campus
Barkhill Road
Liverpool
L17 6BD
United Kingdom
Study information
| Study design | Clustered randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The CHANGE! (Children's Health, Activity and Nutrition: Get Educated!) Project: a clustered randomised controlled trial |
| Study 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(s) | Liverpool John Moores Research Ethics Committee approved on 22nd September 2010, reference number 10/ECL/039 |
| 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 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 | 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 study start date | 01/10/2010 |
| Overall study end date | 31/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | Three-hundred 10-11.9yr old children |
| 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 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
- England
- United Kingdom
Study participating centre
Faculty of Education, Community and Leisure,
Liverpool
L17 6BD
United Kingdom
L17 6BD
United Kingdom
Sponsor information
Liverpool John Moores University (UK)
University/education
University/education
Research Support Office
Liverpool John Moores University
c/o Dr. Sue Spiers
Kingsway House
Hatton Garden
Liverpool
L3 2AJ
England
United Kingdom
"ROR" |
https://ror.org/04zfme737 |
|---|
Funders
Funder type
University/education
Liverpool John Moores University (UK)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- LJMU
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
16/08/2018: Publication reference added.
