Condition category
Not Applicable
Date applied
11/07/2019
Date assigned
30/08/2019
Last edited
02/09/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 March 2022

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sofia Strommer

ORCID ID

Contact details

NIHR Southampton Biomedical Research Centre
University of Southampton
MRC Lifecourse Epidemiology Unit
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
+44 (0)2380 764043
ss3@mrc.soton.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

RP-PG-0216-20004

Study information

Scientific title

Engaging adolescents in changing behaviour (EACH-B): a programme of research to improve the diets and physical activity levels of adolescents

Acronym

EACH-B

Study hypothesis

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

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.

Study design

Multicentre cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a PIS

Condition

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

Phase

Drug names

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

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 trial start date

01/01/2016

Overall trial end date

30/03/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

School children aged 12-13 years (Year 8) at state schools in Hampshire and surrounding areas

Participant type

Other

Age group

Child

Gender

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

Participant exclusion criteria

Single-sex schools

Recruitment start date

11/09/2019

Recruitment end date

31/03/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Swanmore College
New Road
Swanmore
SO32 2RB
United Kingdom

Trial participating centre

Wildern School
Wildern Lane Hedge End
Southampton
SO30 4EJ
United Kingdom

Trial participating centre

Woodlands Community College
Minstead Avenue Harefield
Southampton
SO18 5FW.
United Kingdom

Trial participating centre

Upper Shirley High School
Bellemoor Road Shirley
Southampton
SO15 7QU
United Kingdom

Trial participating centre

Oasis Academy Mayfield
Ashley Crescent
Southampton
SO19 9NA
United Kingdom

Trial participating centre

Oasis Academy Lordshill
Nursling
Southampton
SO16 0XN
United Kingdom

Sponsor information

Organisation

University Hospital of Southampton Foundation Trust (UHSFT)

Sponsor details

Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)23 8077 7222
Mikayala.King@uhs.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.uhs.nhs.uk

Funders

Funder type

Government

Funder name

Programme Grants for Applied Research

Alternative name(s)

NIHR Programme Grants for Applied Research, PGfAR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

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 statement: the data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/01/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/09/2019: Internal review. 15/07/2019: Trial's existence confirmed by the University of Southampton Ethics and Research Governance Online.