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
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	RP-PG-0216-20004
Sponsor	University Hospital of Southampton Foundation Trust (UHSFT)
Funder	Programme Grants for Applied Research

Submission date: 11/07/2019
Registration date: 30/08/2019
Last edited: 10/09/2025

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

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?
Professor Mary Barker, meb@mrc.soton.ac.uk

Contact information

Prof Mary Barker
Scientific

NIHR Southampton Biomedical Research Centre
University of Southampton
MRC Lifecourse Epidemiology Unit
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom

ORCID ID	0000-0003-2976-0217
Phone	+44 (0)23 8077 7624
Email	meb@mrc.soton.ac.uk

Study information

Primary study design	Interventional
Study design	Multicentre cluster randomised controlled trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
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(s)	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
Key secondary outcome measure(s)	Current secondary outcome measures as of 01/09/2025: 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 the process evaluation 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 12. Qualitative feedback on implementation, mechanisms of impact and context. Measured by in-person and online interviews conducted as part of the process evaluation. Interviews conducted with students, teachers, heads of science and parents from intervention and control arm schools which took part in the EACH-B main RCT. Previous 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 the process evaluation 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 the process evaluation 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
Completion date	31/12/2023

Eligibility

Participant type(s)	Other
Age group	Child
Lower age limit	12 Years
Upper age limit	13 Years
Sex	All
Target sample size at registration	2300
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

United Kingdom
England

Study participating centres

Swanmore College

New Road
Swanmore
SO32 2RB
United Kingdom

Wildern School

Wildern Lane
Hedge End
Southampton
SO30 4EJ
United Kingdom

Woodlands Community College

Minstead Avenue
Harefield
Southampton
SO18 5FW.
United Kingdom

Upper Shirley High School

Bellemoor Road
Shirley
Southampton
SO15 7QU
United Kingdom

Oasis Academy Mayfield

Ashley Crescent
Southampton
SO19 9NA
United Kingdom

Oasis Academy Lordshill

Nursling
Southampton
SO16 0XN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in publicly available repository, Available on request
IPD sharing plan	Quantitative data (from primary and secondary outcome measures) collected from schools which took part in the National Institute for Health Research (NIHR)-funded EACH-B trial will be anonymised and uploaded to Pure, the University of Southampton’s institutional research repository (https://eprints.soton.ac.uk/). Data will be uploaded in sections, as and when they are used in published journal articles. This is in line with the university’s policy that all research outputs and activities are recorded in the institutional repository. Data uploaded to Pure will be retained permanently; however, the research team can request that any data within Pure be deleted at any time. Data uploaded to Pure will be designated under the ‘public’ category to comply with the university’s Research Data Management Policy, meaning it will be accessible to anyone. This data sharing plan aligns with the NIHR data sharing policies, which promote openness and transparency in research. Demographic data will only be made available upon reasonable request to Professor Mary Barker, by bona fide researchers and will be fully anonymised and redacted as necessary. Qualitative data (written transcripts from interviews conducted with students, teachers and parents) collected as part of the process evaluation will be shared with bona fide researchers upon request to Professor Mary Barker, in line with institutional data sharing regulations. All qualitative data collected will be anonymised in accordance with the UK Data Service’s guidance on anonymisation of qualitative data (https://ukdataservice.ac.uk/learning-hub/research-data-management/anonymisation/anonymising-qualitative-data), which includes de-identifying names of people and places, including geographical locations and companies. Geographical locations will be anonymised and aggregated at a regional level (for example, ‘Portsmouth’ would be replaced by ‘city in Southern England’). Names of people will be replaced with identifiers (for example, ‘person A’). Names of schools will be replaced with identifiers (for example, ‘school A’). All data anonymisation will be conducted by members of the EACH-B research team, and no other researchers will have access to data prior to anonymisation.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Cost-effectiveness	17/07/2022	10/09/2025	Yes	No
Protocol article	protocol	15/10/2020	22/10/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

10/09/2025: Publication reference added.
01/09/2025: The following changes were made:
1. The secondary outcome measures were updated.
2. A discussion of the mixed-methods process evaluation was added to the plain English summary of protocol.
3. The study contact was changed.
4. The IPD sharing plan was added.
5. The intention to publish date was changed from 31/12/2024 to 31/12/2025.
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.