Move Well, Feel Good feasibility trial
| ISRCTN | ISRCTN23960783 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23960783 |
| Secondary identifying numbers | MWFG1023 |
- Submission date
- 10/10/2023
- Registration date
- 18/10/2023
- Last edited
- 14/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Children’s motor skill ability is linked to mental health problems such as anxiety and depression. The COVID-19 lockdown restrictions negatively affected children’s mental health and reduced their participation in physical activity, which is vital for motor skill development. As school-based programmes are promising ways to tackle declines in motor skills and mental health, this study evaluated the feasibility of an intervention to improve children’s mental health and motor skills.
Who can participate?
Year 5 (age 9-10 years) children from mainstream primary schools who are physically able to participate in Physical Education lessons.
What does the study involve? (for participants)
The children took part in the 'Move Well, Feel Good' intervention programme during school time over one school term. The programme components included Physical Education lessons, break-time activities, home-based tasks, and cross-curricular activities.
What are the possible benefits and risks of participating?
Benefits: improvements in mental health, motor competence, and psychosocial skills
Risks: this was a low-risk project which presented risks of the same magnitude as those which occur during a regular school day.
Where is the study run from?
Edge Hill University (UK)
When is the study starting and how long is it expected to run for?
November 2021 to December 2022
Who is funding the study?
Waterloo Foundation (UK)
Who is the main contact?
Prof. Stuart Fairclough, stuart.fairclough@edgehill.ac.uk
Contact information
Public, Scientific, Principal Investigator
Edge Hill University
St Helens Road
Ormskirk
L39 4QP
United Kingdom
 ORCID ID |
0000-0001-8358-1979 |
|---|---|
| Phone | +44 (0)1695584143 |
| stuart.fairclough@edgehill.ac.uk |
Study information
| Study design | Pre-post design without control group |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | School |
| Study type | Prevention |
| Participant information sheet | 44388_PIS.pdf |
| Scientific title | A primary school-based motor competence and psychosocial skills feasibility intervention to improve children’s mental health and wellbeing |
| Study acronym | MWFG |
| Study objectives | 1. The Move Well, Feel Good intervention programme improves children's mental health and wellbeing more than usual practice 2. The Move Well, Feel Good intervention programme improves children's motor competence more than usual practice 3. The Move Well, Feel Good intervention programme improves children's psychosocial skills more than usual practice |
| Ethics approval(s) |
Approved 01/12/2021, Edge Hill University Science Research Ethics Committee (Edge Hill University, St Helens Road, Ormskirk, L39 4QP, United Kingdom; +44 (0)1695584636; ResearchSystems@edgehill.ac.uk), ref: ETH2122-0062 |
| Health condition(s) or problem(s) studied | Mental health |
| Intervention | A co-produced intervention programme over one school term consisting of one weekly Physical Education lesson, classroom-based activities, home-based tasks, and activities at break times. |
| Intervention type | Behavioural |
| Primary outcome measure | Mental health measured using the Strengths and Difficulties Questionnaire at baseline and at end of intervention (12 weeks post-baseline) |
| Secondary outcome measures | 1. Motor competence measured using the Canadian Agility and Movement Skill Assessment at baseline and at the end of intervention (12 weeks post-baseline) 2. Social skills measured using the prosocial behaviour subscale of the Strengths and Difficulties Questionnaire at baseline and at the end of intervention (12 weeks post-baseline) |
| Overall study start date | 19/11/2021 |
| Completion date | 16/12/2022 |
Eligibility
| Participant type(s) | Learner/student |
|---|---|
| Age group | Child |
| Lower age limit | 9 Years |
| Upper age limit | 10 Years |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 108 |
| Key inclusion criteria | 1. Year 5 (aged 9-10 years) children from one or two-form entry mainstream primary schools 2. Physically able to participate in Physical Education lessons |
| Key exclusion criteria | 1. Children younger than age 9 years and older than age 10 years 2. Not physically able to take part in Physical Education lessons |
| Date of first enrolment | 03/04/2022 |
| Date of final enrolment | 09/09/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Ormskirk
L39 4QP
United Kingdom
Sponsor information
University/education
St Helens Road
Ormskirk
L39 4QP
England
United Kingdom
| Phone | +44 (0)1695 650925 |
|---|---|
| research@edgehill.ac.uk | |
| Website | http://www.edgehill.ac.uk/ |
"ROR" |
https://ror.org/028ndzd53 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- The Waterloo Foundation, TWF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 16/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | The researchers will use press releases to widen project awareness alongside social media to promote and publicise the findings. They will create blog posts suitable for appropriate online outlets (e.g., The Conversation), and share their work with academic, practitioner, and professional audiences through online forums (e.g., Young Minds, Educate Magazine, The Mental Elf), project webinars, and printed publications. They will publish the findings in open access format in peer-reviewed journals which are widely read by their target academic community. |
| IPD sharing plan | The datasets generated during and/or analysed during the study will be stored in anonymised format via the publicly available Open Science Framework at https://osf.io/qfmc7/ The type of data stored: child-level demographic, anthropometric, and outcome data Dates of availability: available now with no end date Whether consent from participants was required and obtained: required and obtained Any ethical or legal restrictions: none, the data are totally de-identified |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Dataset | 10/10/2023 | No | No | ||
| Participant information sheet | 10/10/2023 | No | Yes | ||
| Protocol file | 10/10/2023 | No | No | ||
| Results article | 11/06/2024 | 14/06/2024 | Yes | No |
Additional files
Editorial Notes
14/06/2024: Publication reference added.
10/10/2023: Study's existence confirmed by the Edge Hill University Science Research Ethics Committee.
