A cluster-randomised clinical trial comparing two cardiovascular health education strategies in a child population: the Savinghearts project

Luis María Sánchez-Gómez, María Jesús Fernández-Luque, Lourdes Ruiz-Díaz, Rosa Sánchez-Alcalde, Belén Sierra-García, Soledad Mayayo-Vicente, Marta Ruiz-López, Pilar Loeches-Belinchón, Javier López-Gónzález, Amelia González-Gamarra, Angela Gallego-Arenas, Ana Cubillo-Serna, Gema Gil-Juberias, Pilar Pérez-Cayuela, Celina Arana Cañedo-Arguelles, Julia Natividad García-Pascual, Esther Ruiz-Chércoles, Carmen Suarez-Fernández, Iluminada Garcia-Polo, Daniel Abad-Perez, Juan M Ballesteros-Arribas, Maravillas Izquierdo-Martínez, Elena Salvador-Alcaide, Ana B Arribas-Vela, Juan M Alonso-Pérez, Lorena Veja-Piris, Francisco Rodríguez-Salvanés, Blanca Novella-Arribas, Luis María Sánchez-Gómez, María Jesús Fernández-Luque, Lourdes Ruiz-Díaz, Rosa Sánchez-Alcalde, Belén Sierra-García, Soledad Mayayo-Vicente, Marta Ruiz-López, Pilar Loeches-Belinchón, Javier López-Gónzález, Amelia González-Gamarra, Angela Gallego-Arenas, Ana Cubillo-Serna, Gema Gil-Juberias, Pilar Pérez-Cayuela, Celina Arana Cañedo-Arguelles, Julia Natividad García-Pascual, Esther Ruiz-Chércoles, Carmen Suarez-Fernández, Iluminada Garcia-Polo, Daniel Abad-Perez, Juan M Ballesteros-Arribas, Maravillas Izquierdo-Martínez, Elena Salvador-Alcaide, Ana B Arribas-Vela, Juan M Alonso-Pérez, Lorena Veja-Piris, Francisco Rodríguez-Salvanés, Blanca Novella-Arribas

Abstract

Background: This paper describes a methodology for comparing the effects of an eduentertainment strategy involving a music concert, and a participatory class experience involving the description and making of a healthy breakfast, as educational vehicles for delivering obesity-preventing/cardiovascular health messages to children aged 7-8 years.

Methods/design: This study will involve a cluster-randomised trial with blinded assessment. The study subjects will be children aged 7-8 years of both sexes attending public primary schools in the Madrid Region. The participating schools (n=30) will be randomly assigned to one of two groups: 1) Group MC, in which the children will attend a music concert that delivers obesity-preventing/cardiovascular health messages, or 2) Group HB, in which the children will attend a participatory class providing the same information but involving the description and making of a healthy breakfast. The main outcome measured will be the increase in the number of correct answers scored on a knowledge questionnaire and in an attitudes test administered before and after the above interventions. The secondary outcome recorded will be the reduction in BMI percentile among children deemed overweight/obese prior to the interventions. The required sample size (number of children) was calculated for a comparison of proportions with an α of 0.05 and a β of 0.20, assuming that the Group MC subjects would show values for the measured variables at least 10% higher than those recorded for the subjects of Group HB. Corrections were made for the design effect and assuming a loss to follow-up of 10%. The maximum sample size required will be 2107 children. Data will be analysed using summary measurements for each cluster, both for making estimates and for hypothesis testing. All analyses will be made on an intention-to-treat basis.

Discussion: The intervention providing the best results could be recommended as part of health education for young schoolchildren.

Trial registration: Clinicaltrials.gov: NCT01418872.

Figures

Figure 1
Figure 1
Study design and participant flow through the trial.

References

    1. Mathers C, Boerma T, Fat DM. The global burden of disease: 2004 update. WHO 2008. Geneva, Switzerland: WHO Press; 2008.
    1. Instituto Nacional de Estadística. 2008. [Accessed June 2012]. Available from: .
    1. Biro FM, Wien M. Childhood obesity and adult morbidities. Am J Clin Nutr. 2010;91(5):1499S–1505S. doi: 10.3945/ajcn.2010.28701B.
    1. Nader PR, O'Brien M, Houts R, Bradley R, Belsky J, Crosnoe R, Friedman S, Mei Z, Susman EJ. National Institute of Child Health and Human Development Early Child Care Research Network, Identifying risk for obesity in early childhood. Pediatrics. 2006;118(3):594–601. doi: 10.1542/peds.2005-2801.
    1. CDC. 2010. [Accessed June 2012]. Available from: .
    1. WHO. 2012. [Accessed October 2012]. Available from: .
    1. Ogden CL, Carroll MD, Curtin RL. Prevalence high body mass index in US children and adolescents, 2007–2008. JAMA. 2010;303(3):242–249. doi: 10.1001/jama.2009.2012.
    1. Han JC, Lawlor DA, Kimm SYS. Childhood obesity. Lancet. 2010;375:1737–1748. doi: 10.1016/S0140-6736(10)60171-7.
    1. De Filippo G, Rendina D, Strazzullo P. Childhood obesity, other cardiovascular risk factors, and premature death. N Engl J Med. 2010;362(19):1841.
    1. Lawlor DA, Benfield L, Logue J, Tilling K, Howe LD, Fraser A, Cherry L, Watt P, Ness AR, Davey Smith G, Sattar N. Association between general and central adiposity in childhood, and change in these, with cardiovascular risk factors in adolescence: prospective cohort study. BMJ. 2010;341:6224–6235. doi: 10.1136/bmj.c6224.
    1. Freedman DS, Khan LK, Serdula MK, Dietz WH, Srinivasan SR, Berenson GS. The relation of childhood BMI to adult adiposity: the Bogalusa Heart Study. Pediatrics. 2005;115(1):22–7.
    1. Morrison JA, Glueck CJ, Horn PS, Wang P. Childhood predictors of adult type 2 diabetes at 9- and 26- year follow –up. Arch Pediatr Adolesc Med. 2010;164(1):53–60. doi: 10.1001/archpediatrics.2009.228.
    1. Mattsson N, Rönnemaa T, Juonala M, Viikari JS, Raitakari OT. Childhood predictors of the metabolic syndrome in adulthood. The Cardiovascular Risk in Young Finns Study. Ann Med. 2008;40(7):542–52. doi: 10.1080/07853890802307709.
    1. Juonala M, Magnussen CG, Venn A, Dwyer T, Burns TL, Davis PH, Chen W, Srinivasan SR, Daniels SR, Kähönen M, Laitinen T, Taittonen L, Berenson GS, Viikari JS, Raitakari OT. Influence of age on associations between childhood risk factors and carotid intima-media thickness in adulthood: the Cardiovascular Risk in Young Finns Study, the Childhood Determinants of Adult Health Study, the Bogalusa Heart Study, and the Muscatine Study for the International Childhood Cardiovascular Cohort (i3C) Consortium. Circulation. 2010;122(24):2514–20. doi: 10.1161/CIRCULATIONAHA.110.966465.
    1. Serra Majem L, Ribas Barba L, Aranceta Bartrina J, Pérez Rodrigo C, Saavedra Santana P, Peña Quintana L. Childhood and adolescent obesity in Spain. Results of the enKid study (1998–2000) Med Clin. 2003;29; 121(19):725–3.
    1. Ministerio de Sanidad, Servicios Sociales e Igualdad. Encuesta Nacional de Salud. 2006. [Accessed October 2012]. Available from: .
    1. Katz DL, O'Connell M, Yeh MC, Nawaz H, Njike V, Anderson LM, Cory S, Dietz W. Task Force on Community Preventive Services. Public health strategies for preventing and controlling overweight and obesity in school and worksite settings: a report on recommendations of the Task Force on Community Preventive Services. MMWR Recomm Rep. 2005;7; 54(RR-10):1–12.
    1. Hábitos de salud en la población juvenil de la Comunidad de Madrid 2009. Boletín Epidemiológico de la Comunidad de Madrid. 2010;16(4):4–42.
    1. Grupo Cooperativo Español para el Estudio de los Factores de Riesgo Cardiovascular en la Infancia y Adolescencia. Factores de riesgo cardiovascular en la infancia y adolescencia en España. Estudio Ricardin II: Valores de referencia. An Esp Pediatr. 1995;43:11–17.
    1. Kumanyika SK, Obarzanek E, Stettler N, Bell R, Field AE, Fortmann SP, Franklin BA, Gillman MW, Lewis CE, Poston WC, Stevens J, Hong Y. American Heart Association Council on Epidemiology and Prevention, Interdisciplinary Committee for Prevention. Population-based prevention of obesity: the need for comprehensive promotion of healthful eating, physical activity, and energy balance: a scientific statement from American Heart Association Council on Epidemiology and Prevention, Interdisciplinary Committee for Prevention (formerly the expert panel on population and prevention science) Circulation. 2008;118(4):428–64. doi: 10.1161/CIRCULATIONAHA.108.189702.
    1. Summerbell CD, Waters E, Edmunds LD, Kelly S, Brown T, Campbell KJ. Interventions for preventing obesity in children. Cochrane Database Syst Rev. 2005;20(3):CD001871.
    1. Flynn MA, McNeil DA, Maloff B, Mutasingwa D, Wu M, Ford C, Tough SC. Reducing obesity and related chronic disease risk in children and youth: a synthesis of evidence with 'best practice' recommendations. Obes Rev. 2006;7(Suppl 1):7–66.
    1. Grupo de trabajo de la Guía de Práctica Clínica sobre la Prevención y el Tratamiento de la Obesidad Infantojuvenil. Centro Cochrane Iberoamericano, coordinador. Guía de Práctica Clínica sobre la Prevención y el Tratamiento de la Obesidad Infantojuvenil. Plan de Calidad para el Sistema Nacional de Salud del Ministerio de Sanidad y Política Social. Agència d’Avaluació de Tecnologia i Recerca Mèdiques. Guías de Práctica Clínica en el SNS: AATRM Nº 2007/25. 2009. [Accessed June 2012] Avalaible from: .
    1. Ministerio de Sanidad, Política Social e Igualdad. Nutrición y estrategia NAOS. [Accessed June 2012]. Available from: .
    1. Townsend N, Murphy S, Moore L. The more schools do to promote healthy eating, the healthier the dietary choices by students. JECH Online First, published on November 30. 2010. 0.1136/jech.2010.115600.
    1. Corder K, van Sluijs EM, Steele RM, Stephen AM, Dunn V, Bamber D, Goodyer I, Griffin SJ, Ekelund U. Breakfast consumption and physical activity in British adolescents. Br J Nutr. 2011;105(2):316–322. doi: 10.1017/S0007114510003272.
    1. Murphy S, Moore G, Tapper K, Lynch R, Clarke R, Raisanen L, Desousa C, Moore L. Free healthy breakfasts in primary schools: a cluster randomised controlled trial of a policy intervention in Wales, UK. Public Health Nutr. 2011;14(2):219–226. doi: 10.1017/S1368980010001886.
    1. Berkey CS, Rockett HR, Gillman MW. Longitudinal study of skipping breakfast and weight change in adolescents. Int J Obes Relat Metab Disord. 2003;27:1258–1266. doi: 10.1038/sj.ijo.0802402.
    1. Utter J, Scragg R, Mhurchu CN. et -home breakfast consumption among New Zealand children: associations with body mass index and related nutrition behaviors. J Am Diet Assoc. 2007;107:570–576. doi: 10.1016/j.jada.2007.01.010.
    1. Aranceta J, Serra-Majem L, Ribas L, Pérez-Rodrigo C. Breakfast consumption in Spanish children and young people. Public Health Nutr. 2001;4(6A):1439–44.
    1. Harris KC, Kuramoto LK, Schulzer M, Retallack JE. Effect of school-based physical activity interventions on body mass index in children: a meta-analysis. CMAJ. 2009;180(7):719–726. doi: 10.1503/cmaj.080966.
    1. Portal Salud de la Comunidad de Madrid. Primero desayuna, después comete el día. [Accessed June 2012]. Available from: .
    1. Treurnicht Naylor K, Kingsnorth S, Lamont A, McKeever P, Macarthur C. The effectiveness of music in pediatric healthcare: a systematic review of randomized controlled trials. Evid Based Complement Alternat Med. 2011.
    1. Gold C, Voraceck M, Wigram T. Effects of music therapy for children and adolescents with psycopathology: a meta-analysis. J Child Psychol Psychiatry. 2004;45(6):1054–63. doi: 10.1111/j.1469-7610.2004.t01-1-00298.x.
    1. Maratos AS, Gold C, Wang X, Crawford MJ. Music therapy for depression. Cochrane Database Syst Rev. 2008;23(1):CD004517.
    1. Oelkers-Ax R, Leins A, Parzer P, Hillecke T, Bolay HV, Fischer J, Bender S. et al.Butterbur root extract and music therapy in the prevention of childhood migraine. Eur J Pain. 2008;12(3):301–13. doi: 10.1016/j.ejpain.2007.06.003.
    1. Williams O, Noble J. Hip-Hop’ Stroke. A Stroke Educational Program for Elementary School Children Living in a High-Risk Community. Stroke. 2008;39:2809–2816. doi: 10.1161/STROKEAHA.107.513143.
    1. Marconato C, Cantalejo E, Menim M, Albaca MT. Application of Receptive Music Therapy in Internal Medicine and Cardiology. Arq Bras Cardiol. 2001;77(2):140–1.
    1. Tufte T, Escamilla T. Eduentretenimiento en la comunicación para el VIH/SIDA: más allá del mercadeo, hacia el empoderamiento. Investig Desarro. 2004;12(1):24–43.
    1. Red de Organizadores de Contactos Educativos. [Accessed June 2012]. Available from: .
    1. de Cámara Carlos O. , III [Accessed June 2012]. Available from: .
    1. Armitage P, Berry G, Matthews JNS. Statistical Methods in Medical Research. 4. Oxford (UK): Blackwell Scientific Publications; 1987. pp. 179–185.
    1. Campbell M, Mollison J, Grimshaw J. Cluster trials in implementation research: estimation of intracluster correlation coefficients and sample size. Stat Med. 2001;20:391–399. doi: 10.1002/1097-0258(20010215)20:3<391::AID-SIM800>;2-Z.
    1. Aristimuno GG, Foster TA, Voors AW, Srinivasan SR, Berenson GS. Influence of persistent obesity in children on cardiovascular risk factors: the Bogalusa Heart Study. Circulation. 1984;69:895–904. doi: 10.1161/01.CIR.69.5.895.
    1. Lawlor DA, Leon DA. Association of Body Mass Index and Obesity Measured in Early Childhood With Risk of Coronary Heart Disease and Stroke in Middle Age: Findings From the Aberdeen Children of the 1950s Prospective Cohort Study. Circulation. 2005;111:1891–1896. doi: 10.1161/01.CIR.0000161798.45728.4D.
    1. Bland JM, Kerry SM. Trials randomized in clusters. BMJ. 1997;315:600. doi: 10.1136/bmj.315.7108.600.

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