Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on sleep in brain health

LIVE: Thursday 2nd May 2024, 18:00-19:30 (CEST)

Quality sleep is essential for health. But what happens to our brains when sleep patterns are disturbed? Join our experts to explore the interplay between sleep disruption and neurological diseases, and the questions that you need to be asking your patients to help you prevent the harmful effects of sleep deprivation.
ADVANCED SEARCH
Log in
Top
BMC Public Health
Published in: BMC Public Health 1/2015

Open Access 01-12-2015 | Study protocol

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

Authors: Peymane Adab, Miranda J Pallan, Emma R Lancashire, Karla Hemming, Emma Frew, Tania Griffin, Timothy Barrett, Raj Bhopal, Janet E Cade, Amanda Daley, Jonathan Deeks, Joan Duda, Ulf Ekelund, Paramjit Gill, Eleanor McGee, Jayne Parry, Sandra Passmore, Kar Keung Cheng

Published in: BMC Public Health | Issue 1/2015

Login to get access

Abstract

Background

There is some evidence that school-based interventions are effective in preventing childhood obesity. However, longer term outcomes, equity of effects and cost-effectiveness of interventions have not been assessed.
The aim of this trial is to assess the clinical and cost-effectiveness of a multi-component intervention programme targeting the school and family environment through primary schools, in preventing obesity in 6–7 year old children, compared to usual practice.

Methods

This cluster randomised controlled trial is set in 54 primary schools within the West Midlands, UK, including a multi-ethnic, socioeconomically diverse population of children aged 6–7 years.
The 12-month intervention consists of healthy diet and physical activity promotion. These include: activities to increase time spent doing physical activity within the school day, participation in the ‘Villa Vitality’ programme (a programme that is delivered by an iconic sporting institution (Aston Villa Football Club), which provides interactive learning opportunities for physical activity and healthy eating), healthy cooking skills workshops in school time for parents and children, and provision of information to families signposting local leisure opportunities. The primary (clinical) outcome is the difference in body mass index (BMI) z-scores between arms at 3 and 18 months post-intervention completion. Cost per Quality Adjusted Life Year (QALY) will also be assessed. The sample size estimate (1000 children split across 50 schools at follow-up) is based on 90% power to detect differences in BMI z-score of 0.25 (estimated ICC ≤ 0.04), assuming a correlation between baseline and follow-up BMI z-score of 0.9. Treatment effects will be examined using mixed model ANCOVA. Primary analysis will adjust for baseline BMI z-score, and secondary analysis will adjust for pre-specified baseline school and child level covariates.

Discussion

The West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study is the first trial that will examine the cost-effectiveness and long term outcomes of a childhood obesity prevention programme in a multi-ethnic population, with a sufficient sample size to detect clinically important differences in adiposity. The intervention was developed using the Medical Research Council framework for complex interventions, and outcomes are measured objectively, together with a comprehensive process evaluation.

Trial registration

Current Controlled Trials ISRCTN97000586 (registered May 2010).
Literature
1.
Department of Health. Healthy lives, healthy people: a call to action on obesity in England. London: Department of Health; 2011.
2.
Lobstein T, Baur L, Uauy R, Force IIOT. Obesity in children and young people: a crisis in public health. Obes Rev. 2004;5 Suppl 1:4–104.CrossRefPubMed
3.
Singh AS, Mulder C, Twisk JW, van Mechelen W, Chinapaw MJ. Tracking of childhood overweight into adulthood: a systematic review of the literature. Obes Rev. 2008;9(5):474–88.CrossRefPubMed
4.
Baker JL, Olsen LW, Sørensen TIA. Childhood body-mass index and the risk of coronary heart disease in adulthood. N Engl J Med. 2007;357(23):2329–37.CrossRefPubMedPubMedCentral
5.
Wardle J, Brodersen NH, Cole TJ, Jarvis MJ, Boniface DR. Development of adiposity in adolescence: five year longitudinal study of an ethnically and socioeconomically diverse sample of young people in Britain. BMJ [Br Med J]. 2006;332(7550):1130–5.CrossRef
6.
Serdula MK, Ivery D, Coates RJ, Freedman DS, Williamson DF, Byers T. Do obese children become obese adults? A review of the literature. Prev Med. 1993;22(2):167–77.CrossRefPubMed
7.
Lifestyles statistics team HSCIC. Statistics on Obesity, Physical Activity and Diet. England: Government Statistical Service; 2014.
8.
Rolland-Cachera MF, Deheeger M, Bellisle F, Sempé M, Guilloud-Bataille M, Patois E. Adiposity rebound in children: a simple indicator for predicting obesity. Am J Clin Nutr. 1984;39(1):129–35.PubMed
9.
Waters E, de Silva-Sanigorski A, Hall BJ, Brown T, Campbell KJ, Gao Y, et al. Interventions for preventing obesity in children. Cochrane Database Syst Rev. 2011;12.
10.
Kamath CC, Vickers KS, Ehrlich A. Clinical review: behavioral interventions to prevent childhood obesity: a systematic review and metaanalyses of randomized trials. J Clin Endocrinol Metab. 2008;93(12):4606–15.CrossRefPubMed
11.
Wang Y, Wu Y, Wilson RF, Bleich S, Cheskin L, Weston C, et al. Childhood obesity prevention programs: comparative effectiveness review and meta-analysis. Comparative effectiveness review No. 115. AHRQ Publication No. 13-EHC081-EF. Rockville, MD: Agency for Healthcare Research and Quality; 2013.
12.
13.
Pallan M, Parry J, Cheng K, Adab P. Development of a childhood obesity prevention programme with a focus on UK South Asian communities. Prev Med. 2013;57:948–54.CrossRefPubMedPubMedCentral
14.
Pallan M, Parry J, Adab P. Contextual influences on the development of obesity in children: a case study of UK South Asian communities. Prev Med. 2012;54(3GÇô4):205–11.CrossRefPubMedPubMedCentral
15.
Swinburn B, Egger G, Raza F. Dissecting obesogenic environments: the development and application of a framework for identifying and prioritizing environmental interventions for obesity. Prev Med. 1999;29(6 Pt 1):563–70.CrossRefPubMed
16.
Adab P, Pallan MJ, Cade J, Ekelund U, Barrett T, Daley A, et al. Preventing childhood obesity, phase II feasibility study focusing on South Asians: beaches. BMJ Open. 2014;4(4):e004579. doi:10.1136/bmjopen-2013-004579.CrossRefPubMedPubMedCentral
17.
Griffin T, Pallan M, Clarke J, Lancashire ER, Lyon A, Parry JM. Process evaluation design in a cluster randomised controlled childhood obesity prevention trial: the WAVES study. Int J Behav Nutr Phys Act. 2014;11(1):112.CrossRefPubMedPubMedCentral
18.
19.
20.
21.
22.
Bull FC , the Expert Working Groups. Physical activity guidelines in the U.K.: review and recommendations. School of sport, exercise and health sciences. Loughborough University; 2010.
23.
24.
25.
26.
27.
Cade JE, Frear L, Greenwood DC. Assessment of diet in young children with an emphasis on fruit and vegetable intake: using CADET–Child and Diet Evaluation Tool. Public Health Nutr. 2006;9(4):501–8.CrossRefPubMed
28.
Brage S, Brage N, Franks PW, Ekelund U, Wareham NJ. Reliability and validity of the combined heart rate and movement sensor Actiheart. Eur J Clin Nutr. 2005;59(4):561–70.CrossRefPubMed
29.
Corder K, Brage S, Mattocks C, Ness A, Riddoch C, Wareham NJ. Comparison of two methods to assess PAEE during six activities in children. Med Sci Sports Exerc. 2007;39((12):2180–8.CrossRef
30.
Mattu GS, Heran BS, Wright JM. Comparison of the automated non-invasive oscillometric blood pressure monitor (BpTRU) with the auscultatory mercury sphygmomanometer in a paediatric population. Blood Press Monit. 2004;9(1):39–45.CrossRefPubMed
31.
Varni JW, Seid M, Rode CA. The PedsQL(TM): measurement model for the pediatric quality of life inventory. Med Care. 1999;37(2):126–39.CrossRefPubMed
32.
Ravens-Sieberer U, Gosch A, Rajmil L, Erhart M, Bruil J, Power M. The KIDSCREEN-52 quality of life measure for children and adolescents: psychometric results from a cross-cultural survey in 13 European countries. Value Health. 2008;11(4):645–58.CrossRefPubMed
33.
Truby H, Paxton SJ, British Psychological Society. Development of the children’s body image scale. Br J Clin Psychol. 2002;41(Pt 2):185–203.CrossRefPubMed
34.
Stevens K. Developing a descriptive system for a new preference-based measure of health-related quality of life for children. Qual Life Res. 2009;18(8):1105–13.CrossRefPubMed
35.
Eldridge SM, Ashby D, Kerry S. Sample size for cluster randomized trials: effect of coefficient of variation of cluster size and analysis method. Int J Epidemiol. 2006;35(5):1292–300.CrossRefPubMed
36.
Ford AL, Hunt LP, Cooper A, Shield JP. What reduction in BMI SDS is required in obese adolescents to improve body composition and cardiometabolic health? Arch Dis Child. 2010;95(4):256–61.CrossRefPubMed
37.
Williamson DA, Champagne CM, Harsha D, Han H, Martin CK, Newton Jr R. Design and methods for a childhood obesity prevention program in rural schools. Contemp Clin Trials. 2008;29(5):783–95.CrossRefPubMedPubMedCentral
38.
Hemming K, Marsh J. A menu-driven facility for sample-size calculations in cluster randomized controlled trials. Stata J. 2013;13(1):114–35.
Metadata
Title
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
Authors
Peymane Adab
Miranda J Pallan
Emma R Lancashire
Karla Hemming
Emma Frew
Tania Griffin
Timothy Barrett
Raj Bhopal
Janet E Cade
Amanda Daley
Jonathan Deeks
Joan Duda
Ulf Ekelund
Paramjit Gill
Eleanor McGee
Jayne Parry
Sandra Passmore
Kar Keung Cheng
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2015
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/s12889-015-1800-8

Other articles of this Issue 1/2015

BMC Public Health 1/2015 Go to the issue

Research article

Diabetes, hypertension and mobility among Brazilian older adults: findings from the Brazilian National Household Sample Survey (1998, 2003 and 2008)

Research article

Past oral contraceptive use and self-reported high blood pressure in postmenopausal women

Erratum

Erratum to: A novel antigen capture ELISA for the specific detection of IgG antibodies to elephant endotheliotropic herpes virus

Research article

Inverting the pyramid! Extent and quality of food advertised on Austrian television

Research article

Diarrhoea and smoking: an analysis of decades of observational data from Bangladesh

Research article

Patterns and predictors of workplace health promotion: cross-sectional findings from a company survey in Germany