The WAVES study

The trial was set in the West Midlands, UK, within a multiethnic population. The trial started in November 2010 and continued for 5 years.

The multifaceted 12 month intervention programme targeted the school and family environments and consisted of elements to encourage both healthy eating and physical activity in children. The elements included in the intervention programme were informed by a developmental study, BEACHeS (Birmingham healthy Eating & Active lifestyle for Children Study), that was guided by the early phases of the UK Medical Research Council framework for complex interventions.

The overall aim of the study was to help primary school aged children maintain a healthy weight and thereby prevent overweight and obesity through increasing physical activity and promoting healthy eating by working with schools and communities.

The WAVES study was a cluster randomised controlled trial of an obesity prevention programme. It was a high profile study based in schools and communities in the West Midlands, and the results will inform and feed into national policy and government plans. The programme of activities included in the intervention was developed and piloted (in some Birmingham schools) by a research team in the School of Health and Population Sciences at the University of Birmingham. This pilot work showed promising initial findings and the research team competed with researchers nationally to become successful in securing a prestigious grant from the National Institute for Health and Care Research (NIHR) Health Technology Assessment (NIHR – HTA) programme to undertake the WAVES study.

There were 4 key elements to the intervention programme:

1) Initiatives to increase the amount of daily physical activity children undertake in school by 30 minutes. Schools had 3 main options to choose from in order to achieve this:

• Delivering a structured programme of activity during lunch time.
• A programme involving short bursts of physical activity either at the start and end
  of the school day or between lessons.
• The Take-10 programme which provides lesson plans that include a physical
  activity element to deliver components of the curriculum.

In schools allocated to receive the intervention, individual discussions were undertaken to ascertain what activities the school already undertakes, and based on that, which of the physical activity option(s) would work best in their setting. Relevant school staff were supported as required to help them start to deliver the selected activities.

2) Healthy cooking workshops delivered to children and their parents in school. Three such sessions were delivered (one in each term during the intervention year). These sessions were delivered by school staff as part of a school day and parents are invited to attend. School staff delivering these sessions attended a training day run by the research team to ensure an appropriate level of nutrition knowledge and to familiarise them with the format of the sessions.

3) Participation of children in the ‘Villa Vitality’ (VV) programme, a course of 3 sessions run over 6 weeks by Aston Villa football club, involving physical activity opportunities and interactive learning sessions on healthy eating. The VV programme was originally developed for an older age group (Year 6) but was been adapted for use in the WAVES Study with children in Year 2 (aged 6-7 years).

4) Provision of information to families that gives ideas on how to be active over the summer and that signposts local physical activity and leisure opportunities. The information on summer activity ideas was provided to Year 1 pupils and their families in intervention schools before schools broke up for the summer holidays. The signposting information was provided as early as possible in the Autumn term when the children had just started in Year 2.

A sampling frame including 980 local education authority maintained primary schools in the West Midlands within a 35 miles radius of Birmingham was produced. From this sampling frame 200 schools were selected for invitation using a weighted random sample to try to ensure a wide socioeconomic, ethnic and geographic mix. From this list schools were invited in batches until 54 schools had been recruited to participate in the study. Checks for response bias were undertaken in between each set of invitations sent out but no statistically significant bias was observed.

There were 3 main stages to the study:

Stage 1

During the Spring term, Year 1 children and parents in all participating schools were asked to take part in the study through their school. Children for whom we had consent were then assessed in several ways during the Summer term when they were still in Year 1. The assessments included physical measurements such as height, weight, skin-fold thickness and blood pressure, and a short interview to assess their sense of well-being. Food intake and objective physical activity levels were also measured. In addition, parents were asked to complete questionnaires.

Stage 2

The childhood obesity prevention programme was then introduced to half of the schools and communities participating in the study for one school year, when the children were in Year 2. These schools were randomly selected from all schools who agreed to participate after measurements in all schools had been completed. Measurements were taken for all children, including in schools who did not receive the programme, so that results could be compared between schools receiving and not receiving the programme.

Stage 3

The participating children and parents were assessed in the same way as stage 1, after the intervention programme had finished, when the children were in Year 3. The assessments were repeated yearly for one or two years, to assess the longer term effectiveness of the programme.

The study ran over 5 years.

Although the study involves 54 schools direct involvement with the study has been in two phases. Half (ie 27) of the schools (phase 1) became involved in the 2010/2011 school year with Year 1 pupil and parent recruitment taking place from January to April 2011 (Spring term 2010/2011) and measurements being undertaken from May to July 2011 (Summer term 2010/2011). For schools in phase 1 that were randomly allocated to receive the obesity prevention programme, it was delivered in the 2011/2012 school year when the measured pupils were in Year 2. Follow up measures for children from both the intervention and control schools were undertaken from September to December 2012, January to April 2014 and September to December 2014.

The other half of the schools (phase 2) began direct involvement in the 2011/2012 school year. Year 1 pupil and parent recruitment took place from January to April 2012 (Spring term 2011/2012) with measurements from May to July 2012 (Summer term 2011/2012). For schools in phase 2 that were randomly allocated to receive the obesity prevention programme, it was delivered in the 2012/2013 school year when the measured pupils were in Year 2. Follow up measures for children from both the intervention and control phase 2 schools were undertaken from September to December 2013 and January to April 2015.

The primary outcome measure is the change in BMI z-scores (standardised deviation scores) and this was compared in control and intervention schools at follow up, taking account of clustering, baseline levels and other relevant co-variates. An important secondary outcome is the difference between baseline and follow up in the percentage of children categorised as normal weight, overweight and obese in control compared to intervention schools, using BMI cut-offs based on the UK 1990 reference charts.

Other outcome measures that were considered include differences between control and intervention clusters in:

• Diet – dietary energy intake, dietary fat, sugar and fruit and vegetable intake;
• Physical activity – total physical activity expenditure, time spent in sedentary, light, moderate and vigorous physical activity;
• Quality of life and other psychological outcomes.

In addition, an economic evaluation was undertaken, for which the main outcome measure was an estimate of cost per ‘case of overweight/obesity prevented’.

• Peymane Adab, Miranda J Pallan, Emma R Lancashire, Timothy Barrett, Amanda Daley, Jonathan J Deeks, Joan L Duda, Emma Frew, Paramjit Gill, Tania L Griffin, Karla Hemming, Jayne M Parry, Raj Bhopal, Janet E Cade, Ulf Ekelund, Eleanor McGee, Sandra Passmore and KK Cheng (2015) A cluster-randomised controlled trial to assess the effectiveness and cost-effectiveness of a childhood obesity prevention programme delivered through schools, targeting 6-7 year old children: the WAVES study protocol. BMC Public Health 15: 488. Published online 2015 May 13. doi: 10.1186/s12889-015-1800-8
• JL Clarke, MJ Pallan, ER Lancashire, P Adab, (2015) Obesity prevention in English primary schools: head teacher perspectives. Health Promotion International doi:10.1094/headpro/dav113
• Clarke J, Griffin T, Lancashire E, Adab P, Parry J, Pallan M (2015) Parent and child perceptions of school-based obesity prevention in England: a qualitative study. BMC Public Health 1224;15 http://www.biomedcentral.com/1471-2458/15/1224
• Frew, E J; Pallan, M; Lancashire, E; Hemming, K; Adab, P (2015) Is utility-based quality of life associated with overweight in children? Evidence from the UK WAVES randomised controlled study. BMC Pediatrics 15:211 DOI: 10.1186/s12887-015-0526-1
• Griffin TL, Pallan MJ, Clarke JL, Lancashire ER, Lyon A, Parry JM, Adab P and On behalf of the WAVES study trial investigators (2014) Process evaluation design in a cluster randomised controlled childhood obesity prevention trial: the WAVES study. International Journal of Behavioral Nutrition and Physical Activity, 11:112
• Griffin TL, Clarke JL, Lancashire ER, Pallan MJ, Passmore S, Adab P (2014) Teacher experiences of delivering an obesity prevention programme (The WAVES study intervention) in a primary school setting. Health Education Journal, 74: 655-667 doi 10.1177/0017896914556907, first published on November 7, 2014
• Clarke J, Fletcher B, Lancashire E, Pallan M, Adab P. (2013) The views of stakeholders on the role of the primary school in preventing childhood obesity: a qualitative systematic review. Obesity Reviews,
• Canaway AG; Frew EJ, (2012) Measuring preference-based quality of life in children aged 6–7 years: a comparison of the performance of the CHU-9D and EQ-5D-Y—the WAVES Pilot Study. Qual Life Res Published online 01 February 2012 DOI: 10.1007/s11136-012-0119-5

• Pallan M, Parry J, Cheng KK, Adab P. Development of a childhood obesity prevention programme with a focus on UK South Asian communities. Prev Med . 2013 Sep 6. doi:pii: S0091-7435(13)00317-4. 10.1016/j.ypmed.2013.08.025.
• Pallan MJ, Parry JM, Adab P. Contextual influences on the development of obesity in children: a case study of UK South Asian communities. Prev Med 54(3-4): 205–211.
• Pallan MJ, Hiam LC, Duda JL, Adab P. Body image, body dissatisfaction and weight status in South Asian children: a cross-sectional study. BMC Public Health 2011; 11: 21.
• Brookes, V. Birmingham healthy Eating & Active lifestyle for Children Study. Health Education Journal. Autumn 2007. p52.
• Hiam L, Pallan M, Adab P. Obesity and body dissatisfaction: is there an association? Poster presentation at the Annual Conference of the Faculty of Public Health, 2007.
• Pallan M. Birmingham healthy eating and active lifestyle for children study. Oral presentation at the Annual Conference of the Faculty of Public Health, 2007.
• Teale A, Pallan M, Adab P. Childhood obesity monitoring and prevention research. Chapter in 2006/7 Key Health Data [in press]

• Mohammadpour-Ahranjani B, Pallan MJ, Rashidi A, Adab P. Contributors to childhood obesity in Iran: The views of parents and school staff. Public Health.
• Pallan M, Adab P, Sitch A, Aveyard P. Are school physical activity characteristics associated with weight status in primary school children? A multilevel cross-sectional analysis of routine surveillance data. Arch Dis Child 2013 Oct 23. doi: 10.1136/archdischild-2013-303987.
• Li B, Adab P, Cheng KK. Family and Neighborhood Correlates of Overweight and Obesogenic Behaviors Among Chinese Children . Int J Behav Med. 2013 Sep 21
• The views of stakeholders on the role of the primary school in preventing childhood obesity: a qualitative systematic review. Clarke J, Fletcher B, Lancashire E, Pallan M, Adab P. Obes Rev. 2013 Jul 12. doi: 10.1111/obr.12058