Engaging adolescents in changing behaviour: a programme of research to improve the diets and physical activity levels of adolescents
| ISRCTN | ISRCTN74109264 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74109264 |
| Secondary identifying numbers | RP-PG-0216-20004 |
- Submission date
- 11/07/2019
- Registration date
- 30/08/2019
- Last edited
- 24/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Poor diet and lack of exercise cost the NHS £7 billion a year and cause many to die early. The researchers aim to build and test an intervention to help teenagers eat better and exercise more. Habits formed as teenagers tend to last, and physical and psychological changes during adolescence make it an important time to help them form healthier habits. Making small sustained changes, e.g. eating more fruit and vegetables and being more active, can reduce risks of heart disease or diabetes in later life. Existing interventions for helping teenagers eat better or exercise more, only work for those ready to change, or who see diet and exercise as important. It is known that school-based interventions may be most effective, face-to-face support is helpful, the role of friends/family is important, websites and smartphones are widely used, and teenagers spend time playing games on phones and computers. Using existing knowledge, the researchers have developed an intervention that motivates and supports teenagers to eat better and exercise more, and wan to test this with teenagers from state secondary schools.
Who can participate?
School children aged 12-13 (Year 8) at state schools in Hampshire and surrounding areas
What does the study involve?
Participating schools are randomly allocated to either the intervention group or the control group. The intervention contains three elements:
1. Participation in LifeLab at the University of Southampton: a three-week science module linked to the National Curriculum, which helps teenagers think about science and their health
2. Encouragement from teachers trained to support students to improve their diets and exercise
3. A specially-designed, interactive smartphone app that involves friends and has game features
The control group receive no intervention. Intervention duration is 3 weeks for the teaching of the LifeLab module and up to 3 months for the other components including the digital app. There is one follow-up data collection at 12 months.
What are the possible benefits and risks of participating?
The possible benefits of taking part are: improved awareness about the links between healthy lifestyles and long term health; a better understanding of the role of health research; improvements in dietary quality and physical activity levels. There are no risks involved in participating in this trial and a risk assessment has been done as part of the ethics application.
Where is the study run from?
Medical Research Council Lifecourse Epidemiology Unit (MRC LEU), University of Southampton (UK)
When is the study starting and how long is it expected to run for?
January 2016 to December 2023
Who is funding the study?
NIHR Programme Grants for Applied Research (UK)
Who is the main contact?
Dr Sofia Strommer
ss3@mrc.soton.ac.uk
Contact information
Scientific
NIHR Southampton Biomedical Research Centre
University of Southampton
MRC Lifecourse Epidemiology Unit
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)2380 764043 |
|---|---|
| ss3@mrc.soton.ac.uk |
Study information
| Study design | Multicentre cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | School |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a PIS |
| Scientific title | Engaging adolescents in changing behaviour (EACH-B): a programme of research to improve the diets and physical activity levels of adolescents |
| Study acronym | EACH-B |
| Study objectives | The hypothesis is that LifeLabPlus, comprising engagement with the LifeLab educational programme followed by support from trained teachers and a digital intervention, will improve diet and physical activity levels in 12- to 13-year-old school students. |
| Ethics approval(s) | Pilot trial approved 21/11/2017, full trial approved 21/06/2019, Ethics and Research Governance Online (Faculty of Medicine, University of Southampton, Building 85, Life Sciences Building, Highfield Campus, Southampton, SO17 1BJ; 023 8059 5000; rgoinfo@soton.ac.uk), ref: 30054. |
| Health condition(s) or problem(s) studied | Dietary quality and physical activity levels of teenagers aged 12-13 years old. |
| Intervention | Randomisation will be carried out by the University of Southampton's Clinical Trial Unit and will be at the school level. There will be 25 intervention and 25 control schools. The intervention contains three elements: 1. Participation in LifeLab at the University of Southampton: a three-week science module linked to the National Curriculum, which helps teenagers think about science and their health 2. Encouragement from teachers trained to support students to improve their diets and exercise 3. A specially-designed, interactive smartphone app that involves friends and has game features The pilot trial finished in May 2019 with six schools involved. These are: Upper Shirley High School, Oasis Lordshill, Oasis Mayfield, Woodlands, Wildern, and Swanmore secondary schools, all are based in Hampshire, UK. The control group will receive no intervention. Intervention duration is 3 weeks for the teaching of the LifeLab module and up to 3 months for the other components including the digital app. There is one follow-up data collection at 12 months. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Dietary quality measured by purpose-made, validated Food Frequency Questionnaire (FFQ) at baseline and 12 months post intervention 2. Physical activity measured by accelerometry at baseline and 12 months post baseline |
| Secondary outcome measures | Current secondary outcome measures as of 06/05/2020: Measured at baseline and 12 months post intervention: 1. Well-being measured using Child Health Utility (CHU 9D) and Cantril ladder 2. Self-regulation and motivation for having a healthy lifestyle in adolescence measured using purpose-made Confidence and Behavioural Autonomy questionnaires (undergoing validation) 3. Body composition: height and weight used to calculate BMI Z-scores, taking account of both sitting and standing height as an indicator of pubertal status change 4. Compliance/adherence to intervention protocol measured through process evaluation 5. Self-efficacy for healthy eating and physical activity measured through CBA questionnaires 6. Registration and use of the digital intervention measured through app usage data as part of process evaulation 7. Teachers’ competence in HCS use measured as part of process evaluation 8. Educational outcomes including science GCSE choices at three years post intervention 9. Others specified by intervention planning (WP2.2) 10. Cost of intervention measured via health economics analysis 11. Categories of physical activity measured by accelerometry and validated YPAQ questionnaire Previous secondary outcome measures: Measured at baseline and 12 months post intervention: 1. Well-being measured using EQ-5D-Y and Cantril ladder 2. Self-regulation and motivation for having a healthy lifestyle in adolescence measured using purpose-made Confidence and Behavioural Autonomy questionnaires (undergoing validation) 3. Body composition: height and weight used to calculate BMI Z-scores, taking account of foot size and height changes as an indicator of pubertal status change 4. Compliance/adherence to intervention protocol measured through process evaluation 5. Self-efficacy for healthy eating and physical activity measured through CBA questionnaires 6. Registration and use of the digital intervention measured through app usage data as part of process evaulation 7. Teachers’ competence in HCS use measured as part of process evaluation 8. Educational outcomes including science GCSE choices at three years post intervention 9. Others specified by intervention planning (WP2.2) 10. Cost of intervention measured via health economics analysis 11. Categories of physical activity measured by accelerometry and validated YPAQ questionnaire |
| Overall study start date | 01/01/2016 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 13 Years |
| Sex | Both |
| Target number of participants | Pilot trial: 3 intervention and 3 control schools; Main trial: 2,300 participants from 50 schools, each school represents one cluster |
| Key inclusion criteria | School children aged 12-13 years (Year 8) at state schools in Hampshire and surrounding areas |
| Key exclusion criteria | Single-sex schools |
| Date of first enrolment | 11/09/2019 |
| Date of final enrolment | 31/12/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Swanmore
SO32 2RB
United Kingdom
Hedge End
Southampton
SO30 4EJ
United Kingdom
Harefield
Southampton
SO18 5FW.
United Kingdom
Shirley
Southampton
SO15 7QU
United Kingdom
Southampton
SO19 9NA
United Kingdom
Southampton
SO16 0XN
United Kingdom
Sponsor information
Hospital/treatment centre
Tremona Road
Southampton
SO16 6YD
England
United Kingdom
| Phone | +44 (0)23 8077 7222 |
|---|---|
| Mikayala.King@uhs.nhs.uk | |
| Website | http://www.uhs.nhs.uk |
"ROR" |
https://ror.org/0485axj58 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Programme Grants for Applied Research, PGfAR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Main output from this research will be a fully-developed, replicable intervention to improve adolescents’ diet quality and physical activity. The researchers will determine the success of co-creation processes with adolescents, short, medium and long-term health benefits from intervening in adolescence, intervention cost-effectiveness, including reach/affordability and feasibility of rapid/inexpensive roll-out into routine practice in schools via the national curriculum. Dissemination pathways include: close collaboration with stakeholders, reporting findings to teachers and students, interactive workshops with stakeholders; conference presentations and a series of papers in open access peer-reviewed journals; links with professional societies and policy-makers; regular press releases. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 15/10/2020 | 22/10/2020 | Yes | No |
Editorial Notes
24/03/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/03/2022 to 31/12/2022.
2. The overall trial end date has been changed from 30/06/2023 to 31/12/2023 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 30/12/2023 to 31/12/2024.
01/03/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2021 to 31/03/2022.
2. The overall trial end date was changed from 30/03/2022 to 30/06/2023.
3. The intention to publish date was changed from 30/01/2023 to 30/12/2023.
22/10/2020: Publication reference added.
06/05/2020: The following changes were made to the trial record:
1. Due to current public health guidance, recruitment for this study has been paused.
2. The secondary outcome measures were updated.
02/09/2019: Internal review.
15/07/2019: Trial's existence confirmed by the University of Southampton Ethics and Research Governance Online.
