Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
The proportion of children who are obese has doubled in England in the last ten years and currently one third of 10-11 year olds are overweight or obese. Childhood obesity is associated with health issues in childhood as well as reduced self-esteem and quality of life. Obese children are also likely to become obese adults and experience significant health issues because of their weight. As current behavioural obesity treatments for children appear to have little effect, preventing children from becoming obese is an important issue for the Health Service. There is currently no good evidence to suggest which obesity prevention programmes are effective or how to engage schools, children and their families sufficiently to affect obesity-related behaviours. We have worked with schools, children and their families over five years to develop and refine a novel, inclusive, drama-based, healthy lifestyles programme called ‘HeLP’. The programme is delivered specifically to Year 5 (9-10 year old) children in the primary school setting but it also seeks to impact the whole school environment to create a supportive social context at the level of the school and family. HeLP combines education sessions, interactive drama workshops and goal setting, all with parental involvement, to promote and support sustainable changes in diet and physical activity.
HeLP aims to deliver a general healthy lifestyle message for the whole year group around the energy balance with a focus on three specific behaviours: to reduce the consumption of sweetened fizzy drinks, to increase the proportion of healthy to unhealthy snacks consumed and to reduce screen time. HeLP avoids creating special or discriminating treatment for those who are overweight. The main focus of the programme is a week of drama-based activities led by actors from a local theatre group. Four characters have been created with positive and negative lifestyle behaviours. Participating children select which character they most resemble and work with that character throughout the week, suggesting ways in which the character can alter their behaviours. The following week the children set goals with their families and the researchers, suggesting three behaviours they will target for improvement.
We have developed and tested HeLP in six schools including 398 children and their families. At each stage of the pilot work we have sought to understand whether the activities are acceptable and feasible for schools, children and their families. Three of the schools involved in the development were in the more deprived parts of the area, ensuring that the programme was acceptable and feasible to all socioeconomic groups. Extensive interviews with children, parents and teachers showed that children, parents and schools were happy to participate in all intervention activities. Parents were adamant their children’s diet and activity choices were their responsibility but felt that school was a good place to reinforce these messages. Following delivery of HeLP, parents reported greater acceptance of rules relating to screen-time activities and healthy eating by their child as well as their child initiating discussion with other family members around healthy lifestyles and making suggestions to get the whole family involved in eating more healthily and being more active. Teachers agreed Year 5 was the right target group as children are gaining independence whilst still amenable to the messages. Some commented that the intervention had boosted the children’s self-esteem, had a positive effect on the class socially and created additional opportunities to link with parents. Teachers felt using young actors to deliver the messages was the key to achieving engagement with this age group. Children were unanimous in their enjoyment of the drama activities.

Who can participate?
Schools are eligible to participate if they are mainstream state-run primary schools and have at least one single Year 5 class (i.e. not Year 4/5 or 5/6 mixed classes).

What does the study involve?
We want to test HeLP with about 1000 children (9-10 year olds) from 32 schools; half of the schools (about 500 children) will be randomly selected to receive HeLP and they will be compared with the 16 schools (about 500 children) that do not. The success of the Programme will be judged by comparing measures of weight, physical activity and dietary behaviours between the groups of children at 18 and 24 months.

What are the possible benefits and risks of participating?
HeLP has the potential to improve participating children’s physical activity levels and dietary behaviours. Taking body measurements from children of this age could lead to stigmatising the overweight child; however, we have ensured that these are taken in a friendly, private and non-threatening environment. No child, teacher or parent in three phases of piloting has made any negative comments regarding these measures. Indeed, in focus groups, children did not spontaneously comment on the weighing and measuring and when this was highlighted the children dismissed these measurements as ‘fine’.

Where is the study run from?
The study will be run from the Peninsula College of Medicine and Dentistry in Exeter in the South West of England (UK).

When is study starting and how long is it expected to run for?
March 2012 to October 2016

Who is funding the study?
National Institute for Research (NIHR) (UK)

Who is the main contact?
Dr Katrina Wyatt

Trial website

Contact information



Primary contact

Dr Katrina Wyatt


Contact details

Peninsula College of Medicine & Dentistry
Veysey Building
Salmon Pool Lane
United Kingdom
+44 (0)1392 722 971

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Cluster randomised controlled trial, economic and process evaluation to determine the effectiveness and cost effectiveness of a novel intervention Healthy Lifestyles Programme (HeLP) to prevent obesity in school children



Study hypothesis

A novel school-based programme of activities will engage school children and their families sufficiently to affect dietary and activity behaviours and prevent excessive weight gain in 9-10 year olds.

Ethics approval

Peninsula College of Medicine & Dentistry Research Ethics Committee, ref: 12/03/140

Study design

Cluster randomised controlled trial with economic and process evaluation

Primary study design


Secondary study design

Cluster randomised trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Public health


HeLP is a multi-component four phase programme which takes place over three school terms and aims to deliver a general healthy lifestyle message encouraging a healthy energy balance. Piloting has demonstrated that the children found it useful to focus on three specific behaviours related to energy intake and expenditure:
1. A decrease in the consumption of sweetened fizzy drinks
2. Increasing the ratio of healthy to unhealthy snacks
3. A reduction in screen-based activities

Throughout the Programme the children are encouraged to find acceptable activity and dietary replacements in order to maintain a healthy energy balance. HeLP includes a range of behaviour change techniques (BCTs) and accessible and engaging delivery methods which are compatible with the existing school curriculum, as well as providing several opportunities for parental engagement. Our hypothesis is that targeting information, motivation and behavioural skills will lead to improvements in diet and physical activity thus preventing excessive weight gain and that these processes may be moderated by gender, weight status, socioeconomic circumstances and school size.

Schools in the comparison arm will receive no intervention. Usual practice will be characterised using a pre-determined checklist of potential school level mediators. After completion of 24 month outcome measures, control schools will be offered £1000 to acknowledge their participation in the trial.

Intervention type



Drug names

Primary outcome measure

Body Mass Index (BMI) Standard Deviation Score (SDS) measured at baseline, 18 and 24 months which will be compared between the control and intervention groups

Secondary outcome measures

1. Weight Status Proportions (underweight, normal, obese or overweight) measured at baseline, 18 and 24 months
2. Percent body fat measured at baseline, 18 and 24 months
3. Waist circumference measured at baseline, 18 and 24 months
4. Accelerometer assessed moderate/vigourous physical activity/sedentary behaviour measured at baseline and 18 months
5. Mean number of healthy snacks, energy dense snacks, positive and negative foods consumed per day measured at baseline and 18 months
6. Mediating variables to assess knowledge, motivation and behaviours relating to the physical activity and diet measured at baseline and 12 months

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. State Primary/Junior schools in Devon and Plymouth
2. Year 5 children (9-10 year olds)

Participant type


Age group




Target number of participants

32 schools including 1000 9-10 year olds

Total final enrolment


Participant exclusion criteria

Schools which received the intervention in the pilot phases and schools who do not have a single Year 5 group

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Peninsula College of Medicine & Dentistry
United Kingdom

Sponsor information


Royal Devon and Exeter NHS Foundation Trust (UK)

Sponsor details

c/o Mr Chris Gardner
Noy Scott House
Barrack Road
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

National Institute for Health Research (NIHR) (UK) - Public Health Research Programme ref: 10/3010/01

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

National government


United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

1. 2013 protocol in:
2. 2016 statistical analysis plan in:
3. 2017 baseline results in:
4. 2018 physical activity prevalence results in: (added 02/07/2019)
5. 2018 results in: (added 13/09/2019)

Publication citations

  1. Protocol

    Wyatt KM, Lloyd JJ, Abraham C, Creanor S, Dean S, Densham E, Daurge W, Green C, Hillsdon M, Pearson V, Taylor RS, Tomlinson R, Logan S, The Healthy Lifestyles Programme (HeLP), a novel school-based intervention to prevent obesity in school children: study protocol for a randomised controlled trial., Trials, 2013, 14, 95, doi: 10.1186/1745-6215-14-95.

Additional files

Editorial Notes

13/09/2019: Publication reference and total final enrolment added. 02/07/2019: Publication reference added. 06/04/2017: Publication reference added. 03/01/2017: Publication reference added. 24/11/2016: The recruitment dates have been changed from 01/03/2012 - 31/10/2016 to 01/07/2012 - 30/09/2013.