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Healthy Lifestyles Programme to prevent childhood obesity
ISRCTN ISRCTN15811706
DOI 10.1186/ISRCTN15811706
ClinicalTrials.gov identifier
EudraCT number
Public title Healthy Lifestyles Programme to prevent childhood obesity
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
Acronym HeLP
Serial number at source 10/3010/01
Study hypothesis A novel school-based programme of activities will engage schools children and their families sufficiently to affect dietary and activity behaviours and prevent excessive weight gain in 9-10 year olds.
Lay 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?
The study will begin in March 2012 and end in October 2016 (56 months in total).

Who is funding the study?
The study is funded by the National Institute for Research (NIHR) (UK).

Who is the main contact?
Dr Katrina Wyatt
katrina.wyatt@pms.ac.uk
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
Countries of recruitment United Kingdom
Disease/condition/study domain Public Health
Participants - inclusion criteria 1. State Primary / Junior schools in Devon and Plymouth
2. Year 5 children (9-10 year olds)
Participants - exclusion criteria Schools which received the intervention in the pilot phases and schools who do not have a single Year 5 group
Anticipated start date 01/03/2012
Anticipated end date 31/10/2016
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 32 schools including 1000 9-10 year olds
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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
Sources of funding National Institute for Health Research [NIHR[ (UK) - Public Health Research Programme ref: 10/3010/01
Trial website
Publications 1. 2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23556434
Contact name Dr  Katrina  Wyatt
  Address Peninsula College of Medicine & Dentistry
Veysey Building
Salmon Pool Lane
Devon
  City/town Exeter
  Zip/Postcode EX2 4SG
  Country United Kingdom
  Tel +44 (0)1392 722 971
  Email katrina.wyatt@pms.ac.uk
Sponsor Royal Devon and Exeter NHS Foundation Trust (UK)
  Address c/o Mr Chris Gardner
Noy Scott House
Barrack Road
Devon
  City/town Exeter
  Zip/Postcode EX2 5DW
  Country United Kingdom
  Sponsor website: http://www.rdehospital.nhs.uk/
Date applied 14/03/2012
Last edited 22/11/2013
Date ISRCTN assigned 01/05/2012
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