Evaluation of a family intervention programme for the treatment of overweight and obese children (Nereu Programme): a randomized clinical trial study protocol

BMC Public Health

Concepció Teixidó⁶  Jose Maria Mur¹  Jordi Bosch-Muñoz⁵  Eduard Solé-Mir⁵  Gisela Galindo⁶  Amalia Zapata³  Iván Castro-Viñuales¹  Jordi Real²  Assumpta Ensenyat⁴  Noemi Serra-Paya⁴ 

[1] Nereu’s Association, Food and Healthy Physical Exercise, Health Region of Lleida, Lleida, Spain;Universitat Internacional de Catalunya, Sant Cugat, Spain;Nursery Department, University of Lleida, Lleida, Spain;National Institute for Physical Education of Catalonia (INEFC) of Lleida, University of Lleida, Partida Caparrella s/n, 25191 Lleida, Spain;Department of Paediatrics Hospital Universitari Arnau de Vilanova, Lleida, Spain;Centre d'Atenció Primària Primer de Maig. Institut Català de la Salut, Lleida, Spain

关键词: Paediatric unit;    Sedentary;    Health;    Behaviour;    Nutrition;    Physical activity;    Children;    Obesity;   

Others  :  1161622
DOI  :  10.1186/1471-2458-13-1000

 received in 2013-08-19, accepted in 2013-10-09,  发布年份 2013

【 摘 要 】

Background

Obesity is mainly attributed to environmental factors. In developed countries, the time spent on physical activity tasks is decreasing, whereas sedentary behaviour patterns are increasing.

The purpose of the intervention is to evaluate the effectiveness of an intensive family-based behavioural multi-component intervention (Nereu programme) and compared it to counselling intervention such as a health centre intervention programme for the management of children’s obesity.

Methods/Design

The study design is a randomized controlled multicenter clinical trial using two types of interventions: Nereu and Counselling. The Nereu programme is an 8-month intensive family-based multi-component behavioural intervention. This programme is based on a multidisciplinary intervention consisting of 4 components: physical activity sessions for children, family theoretical and practical sessions for parents, behaviour strategy sessions involving both, parents and children, and lastly, weekend extra activities for all. Counselling is offered to the family in the form of a monthly physical health and eating habits session. Participants will be recruited according the following criteria: 6 to 12 year-old-children, referred from their paediatricians due to overweight or obesity according the International Obesity Task Force criteria and with a sedentary profile (less than 2 hours per week of physical activity), they must live in or near the municipality of Lleida (Spain) and their healthcare paediatric unit must have previously accepted to cooperate with this study. The following variables will be evaluated: a) cardiovascular risk factors (anthropometric parameters, blood test and blood pressure), b) sedentary and physical activity behaviour and dietary intake, c) psychological aspects d) health related quality of life (HRQOL), e) cost-effectiveness of the intervention in relation to HRQOL. These variables will be then be evaluated 4 times longitudinally: at baseline, at the end of the intervention (8 months later), 6 and 12 months after the intervention. We have considered necessary to recruit 100 children and divide them in 2 groups of 50 to detect the differences between the groups.

Discussion

This trial will provide new evidence for the long-term effects of childhood obesity management, as well as help to know the impact of the present intervention as a health intervention tool for healthcare centres.

Trial registration

ClinicalTrials.gov, NCT01878994

【 授权许可】

   
2013 Serra-Paya et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Encuesta Nacional de Salud Pública. Ministerio de Sanidad y Consumo, 2003, 2006 and 2010 [http://www.msc.es/estadEstudios/estadisticas/encuestaNacional/ webcite]
• [2]Aladino Study [http://www.naos.aesan.msps.es/naos/investigacion/aladino/ webcite]
• [3]Hill JO, Peters JC: Environmental contributions to the obesity epidemic. Science 1998, 280:1371-1374.
• [4]Serra-Majem L, Barbab LB, Aranceta J, Pérez C, Saavedra P, Peña L: Obesidad Infantil y Juvenil en España. Resultados Del Estudio Enkid (1998–2000). Med Clin (Barc) 2003, 121:324-725.
• [5]Salas-Salvadó J, et al.: Consenso SEEDO 2007 para la evaluación del sobrepeso y la obesidad y el establecimiento de criterios de intervención terapéutica. Med Clin (Barc) 2007, 128:184-196.
• [6]Williams J, Wake M, Hesketh K, Maher E, Waters E: Health-related quality of life of overweight and obese children. JAMA 2005, 293:70-76.
• [7]Waters E, de Silva-Sanigorski A, Hall BJ, Brown T, Campbell KJ, Gao Y, Armstrong R, Prosser L, Summerbell CD: Interventions for preventing obesity in children. Cochrane Database Syst Rev12: 00, 2011
• [8]Viner RM, Cole TJ: Adult socioeconomic, educational, social, and psychological outcomes of childhood obesity: a national birth cohort study. BMJ 2005, 330:1354.
• [9]Connelly JB, Duaso MJ, Butler GA: A systematic review of controlled trials of interventions to prevent childhood obesity and overweight: A realistic synthesis of the evidence. Public Health 2007, 121:510-517.
• [10]Gutin B, Barbeau P, Owens S, Lemmon CR, Bauman M, Allison J, Kang HS, Litaker MS: Effects of exercise intensity on cardiovascular fitness, total body composition, and visceral adiposity of obese adolescents. Am J Clin Nutr 2002, 75:818-826.
• [11]Carrel AL, Clark RR, Peterson SE, Nemeth BA, Sullivan J, Allen DB: Improvement of fitness, body composition, and insulin sensitivity in overweight children in a school-based exercise program: a randomized, controlled study. Arch Pediatr Adolesc Med 2005, 159:963-968.
• [12]Daley AJ, Copeland RJ, Wright NP, Roalfe A, Wales JK: Exercise therapy as a treatment for psychopathologic conditions in obese and morbidly obese adolescents: a randomized, controlled trial. Pediatrics 2006, 118:2126-2134.
• [13]Trinh A, Campbell M, Ukoumunne OC, Gerner B, Wake M: Physical activity and 3-year BMI change in overweight and obese children. Pediatrics 2013, 131:e470-e477.
• [14]Atlantis E, Barnes EH, Singh MA: Efficacy of exercise for treating overweight in children and adolescents: A systematic review. Int J Obes 2006, 30:1027-1040.
• [15]McGovern L, Johnson JN, Paulo R, Hettinger A, Singhal V, Kamath C, Erwin PJ, Montori VM: Treatment of pediatric obesity: a systematic review and meta-analysis of randomized trials. J Clin Endocrinol Metab 2008, 93:4600-4605.
• [16]Spruijt-metz D: Etiology, treatment, and prevention of obesity in childhood and adolescence: a decade in review. J Res Adolesc 2011, 21:129-152.
• [17]Oude Luttikhuis H, Baur L, Jansen H, Shrewsbury VA, O’Malley C, Stolk RP, Summerbell CD: Interventions for treating obesity in children. Cochrane Database Syst Rev 2009., (Issue 1) Art.No.:CD001872
• [18]Whitlock EP, Tracy Orleans C, Pender N, Allan J: Evaluating primary care BehavioralCounseling Interventions. An evidence-based approach. Am J Prev Med 2002, 22:267-284.
• [19]Hughes AR, Stewart L, Chapple J, McColl JH, Donaldson MDC, Kelnar CJH, Zabihollah M: JJ: Randomized, controlled trial of a best-practice individualized behavioral program for treatment of childhood overweight: Scottish Childhood Overweight Treatment Trial (SCOTT). Pediatrics 2008, 121:e539-e546.
• [20]Golan M, Kaufman V, Shahar DR: Childhood obesity treatment: targeting parents exclusively v. parents and children. Br J Nutr 2006, 95:1008-1015.
• [21]Kitzmann KM, William DT, Stanley CM, Beech BM, Reeves TP, Buscemi J, Egli CJ, Gamble HL, Midgett EL: Lifestyle interventions for youth who are overweight: a meta-analytic review. Health Psychol 2010, 29:91-101.
• [22]Munsch S, Roth B, Michael T, Meyer AH, Biedert E, Roth S, Speck V, Zumsteg U, Isler E, Margraf J: Randomized controlled comparison of two cognitive behavioral therapies for obese children: mother versus mother-child cognitive behavioral therapy. Psychother Psychosom 2008, 77:235-246.
• [23]Cole TJ, Bellizzi MC, Flegal KM, Dietz WH: Establishing a standard definition for child overweight and obesity worldwide: international survey. BMJ 2000, 2000(320):1-6.
• [24]Wilfley DE, Tibbs TL, Van Buren DJ, Reach KP, Walker MS, Epstein LH: Lifestyle interventions in the treatment of childhood overweight: a meta-analytic review of randomized controlled trials. Health Psychol 2007, 26(5):521-532.
• [25]Word Medical Association. Declaration of Helsinki - Ethical principles for medical research involving human subjectshttp://www.wma.net/en/30publications/10policies/b3/index.html webcite
• [26]IDIAP: Guidelines for Good Practice in Primary Care Research. 08002 Barcelona: Fundació Jordi Gol i Gurina; 2010. ISBN: 978-84-96761-94-0
• [27]Schulz K, Altman D, Moher D, Group TC: CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med 2010, 8:18. BioMed Central Full Text
• [28]McWhorter W, Wallmann HW, Alpert PT: The obese child: motivation as a tool for exercise. J Pediatr Health Care 2003, 17:11-17.
• [29]Sothern M, Hunter S, Suskind R, Brown R, Udall J, Blecker U: Motivating the obese child to move: the role of structured exercise in pediatric weight management. South Med J 1999, 92:577-584.
• [30]ACSM (American College of Sports Medicine): ACSM’s Guidelines for Exercise Testing and Prescription American College of Sports Medicine. 8th edition. Baltimore: Lippincott Williams & Wilkins; 2010. ISBN: 0781769035
• [31]Aznar S, Webster T: Actividad física y salud en la infancia y la adolescencia: guía para todas las personas que participan en su educación. Madrid: Ministerio de Educación y Cultura; 2006.
• [32]WHO: Recomendaciones mundiales sobre actividad física para la salud. 2010. http://www.naos.aesan.msssi.gob.es/naos/ficheros/investigacion/WHO_Recomendaciones_Actvidad_Fisica_Salud.pdf webcite
• [33]ACSM (American College of Sports Medicine): Guidelines for exercise testing and prescription. 6th edition. Philadelphia: Lea & Febiger; 2000:214-216.
• [34]Daley AJ, Copeland RJ, Wright NP, Wales JKH: Protocol for: Sheffield Obesity Trial (SHOT): A randomised controlled trial of exercise therapy and mental health outcomes in obese adolescents. BMC Public Health 2005, 5:113. BioMed Central Full Text
• [35]Bandura A: Social Foundations of Thought and Action: A Social Cognitive Theory. Englewood Cliffs, N.J: Prentice-Hall; 1986.
• [36]AESAN: La alimentación de tus niños y niñas. Agencia Española de Seguridad Alimentaria y Nutrición. Ministerio de Sanidad, Política Social e Igualdad; 2011. http://www.naos.aesan.msssi.gob.es/naos/ficheros/investigacion/publicacion2limentacionNinios.pdf webcite
• [37]CECC: Alimentación en familia. Confederación Española de Cooperativas de Comunidades y Usuarios e Instituto Nacional del Consumo. 2010. http://www.naos.aesan.msssi.gob.es/naos/ficheros/investigacion/alimentacion_familia_HISPACOOP.pdf webcite
• [38]COM: Libro Verde: Fomentar una alimentación sana y la actividad física: una dimensión europea para la prevención del exceso de peso, la obesidad y las enfermedades crónicas. 2005. http://eur-lex.europa.eu/LexUriServ/site/es/com/2005/com2005_0637es01.pdf webcite
• [39]WHO, Joint; CONSULTATION, FAO Expert: Diet, nutrition and the prevention of chronic diseases: report of a joint WHO/FAO expert consultation. WHO technical report series 2002, 916.
• [40]Pan H, Cole TJ: LMS growth, a Microsoft Excel add-in to access growth references based on the LMS method. Version 2.77. http://www.healthforallchildren.co.uk/ webcite
• [41]Fernández-Goula ME, Callís L, et al.: Estudio transversal de la tensión arterial entre la población de 4–18 años de Cataluña. Granada: A: XXI Reunión anual de la Asociación Española de Pediatría; 1989.
• [42]The ALPHA Health Related Fitness Test Battery for Children and Adolescents. Test Manual http://www.thealphaproject.net webcite
• [43]Morinder G, Mattsson E, Sollander C, Marcus C, Larsson UE: Six-minute walk test in obese children and adolescents: reproducibility and validity. Physiotherapy Research International. Physiother Res Int 2009, 14:91-104.
• [44]Freedson P, Pober D, Janz K: Calibration of accelerometer output for children. Med Sci Sports Exerc 2005, 37:523-530.
• [45]Mandich GE: Physical activity among latino children in london, ontario: an assessment of physical activity levels, sedentary behaviours, and physical activity-related barriers and facilitators. The School of Graduate and Postdoctoral Studies. Gillian Mandich: The University of Western Ontario; 2012.
• [46]Kowalski KC, Crocker PR, Faulkner RA: Validation of the physical activity questionnaire for older children. Pediatr Exerc Sci 1997, 9:174-186.
• [47]Janz KF, Lutuchy EM, Wenthe P, Levy SM: Measuring activity in children and adolescents using self-report: PAQ-C and PAQ-A. Med Sci Sports Exerc 2008, 40:767-772.
• [48]Crocker PR, Bailey DA, Faulkner RA, Kowalski KC, McGrath R: Measuring general levels of physical activity: preliminary evidence for the physical activity questionnaire for older children. Med Sci Sports Exerc 1997, 29:1344-1349.
• [49]Crocker PRE, Holowachuk DR, Kowalski KC: Feasibility of using the Tritrac motion sensor over a 7-day trial with older children. Pediatr Exerc Sci 2001, 13:70-81.
• [50]Moore JB, Hanes JC Jr, Barbeau P, Gutin B, Trevino RP, Yin Z: Validation of the physical activity questionnaire for older children in children of different races. Pediatr Exerc Sci 2007, 19:6-19.
• [51]Kent C, Kowalski PR, Crocker E, Donen RM: The Physical Activity Questionnaire for Older Children (PAQ-C) and Adolescents (PAQ-A) Manual. College of Kinesiology. Saskatoon, SK, Canada: University of Saskatchewan; 2004.
• [52]Martin-Moreno JM, Gorgojo L: Valoración de la ingesta dietética a nivel poblacional mediante cuestionarios individuales: sombras y luces metodológicas. Rev Esp Salud Publica 2007, 81(5):507-518.
• [53]Willett WC: Nutritional epidemiology: monographs in epidemiology and biostatistics. Nutritional epidemiology: Monographs in epidemiology and biostatistics 1998.
• [54]Willett W: Nutritional epidemiology. Vol. 40. Oxford University Press; 2012.
• [55]Martin-Moreno JM, Boyle P, Gorgojo L, Maisonneuve P, Fernandez-Rodriguez JC, Salvini S, et al.: Development and validation of a food frequency questionnaire in Spain. Int J Epidemiol 1993, 22(3):512-519.
• [56]Salvador G, Palma I, Puchal A, Vilá M, Miserachs M: Entrevista dietética. Herramientas útiles para la recogida de datos. Revista de medicina 2006, 50(4):46-55.
• [57]Rodríguez TI, Fernández J, Pastor CG, Jordà BE, Val AV: Validación de un cuestionario de frecuencia de consumo alimentario corto: reproducibilidad y validez. Nutr Hosp 2008, 23(3):242-252.
• [58]Vioque J: Validez la evaluacion de la ingesta dietetica. In Nutricion y Salud Publica. Metodos, bases cientficas y aplicaciones. Edited by Aranceta-Bartrina J LY. Barcelona: Masson-Elsevier; 2006:199-210.
• [59]Field AE, Peterson KE, Gortmaker SL, Cheung L, Rockett H, Fox MK, et al.: Reproducibility and validity of a food frequency questionnaire among fourth to seventh grade inner-city school children: implications of age and day-to-day variation in dietary intake. Public Health Nutr 1999, 2:293-300.
• [60]Rockett HR, Wolf AM, Colditz GA: Development and reproducibility of a food frequency questionnaire to assess diets of older children and adolescents. J Am Diet Assoc 1995, 95(3):336-340.
• [61]Sabaté J: Estimación de la ingesta dietética: métodos y desafíos. Med Clin 1993, 100:591-596.
• [62]Aguirre-Jaime A, Cabrera de León A, Domínguez SC, Borges CA, Carrillo LF, Gavilán Batista JC, et al.: Validación de un cuestionario de frecuencia de consumo de alimentos adaptado para el estudio y seguimiento de la población adulta de las Islas Canarias. Revista Española de Salud Pública 2008, 82(5):509-518.
• [63]Fundación Española de la Nutrición (FEN): Libro blanco de la nutrición en España. 2013. http://www.aesan.mspsi.gob.es/AESAN/docs/docs/publicaciones_estudios/nutricion/Libro_Blanco_Nutricion_Esp.pdf webcite
• [64]Aedo A, Ávila H: Nuevo cuestionario para evaluar la autoeficacia hacia la actividad física en niños. Rev Panam Salud Publica 2009, 26(4):324-329.
• [65]Moreno JA, Moreno R, Cervelló E: El autoconcepto físico como predictor de la intención de ser físicamente activo. Psicología y Salud 2007, 17(2):261-267.
• [66]Hein V, Müür M, Koka A: Intention to be physically active after school graduation and its relationship to three types of intrinsic motivation. Eur Phys Educ Rev 2004, 10(1):5-19.
• [67]Collins ME: Body figure perceptions and preferences among preadolescent children. Int J Eat Disord 1991, 10:199-208.
• [68]Moreno JA, González-Cutre D, Martínez Galindo C, Alonso N, López M: Propiedades psicométricas de la Physical Activity Enjoyment Scale (PACES) en el contexto español. Estudios de Psicología 2008, 29(2):173-180.
• [69]Moore JB, John Hanes ZY, Duda J, Gutin B, Barbeau P: Measuring enjoyment of physical activity in children: validation of the physical activity enjoyment scale. J Appl Sport Psychol 2009, 21(S1):S116-S129.
• [70]Varni JW, et al.: The PedsQL™: measurement model for the pediatric quality of life inventory. Med Care 1999, 37(2):126-139.
• [71]Varni JW, Burwinkle TM, Seid M: The PedsQL 4.0 as a school population health measure: feasibility, reliability, and validity. QualLife Res 2006, 15(2):203-215.
• [72]Varni JW, et al.: The PedsQL™ 4.0 as a pediatric population health measure: Feasibility, reliability, and validity. Ambul Pediat 2003, 3:329-341.
• [73]Stevens KJ: Assessing the performance of a new generic measure of health related quality of life for children and refining it for use in health state valuation. Appl Health Econ Health Policy 2011, 9:157-169.
• [74]Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, Oja P: International physical activity questionnaire: 12-country reliability and validity. Med Sci Exer 2003, 35(8):1381-1395.
• [75]Booth ML: Assessment of physical activity: an international perspective. Res Q Exerc Sport 2000, 71(2):s114-s120.
• [76]Hallal PC, Victora CG: Reliability and validity of the International Physical Activity Questionnaire (IPAQ). Med Sci Sports Exerc 2004, 36(3):556.
• [77]IPAQ: To analyze the questioner will be used the guidelines for data processing and analysis of the International Physical Activity Questionnaire (IPAQ). 2005. http://www.ipaq.ki.se/scoring.pdf webcite
• [78]Feskanich D, Rimm EB, Giovannucci EL, Colditz GA, Stampfer MJ, Litin LB, et al.: Reproducibility and validity of food intake measurements from a semiquantitative food frequency questionnaire. J Am Diet Assoc 1993, 93(7):790-796.
• [79]González M, Puig M, Romagosa A, Casellas C, Grau M, Segurola H: Patrones alimenticios y valoración del estado nutricional en población adulta atendida en la Atención Primaria. Butlletí de la Societat Catalana de Medicina Familiar i Comunitària 2009, 27:1-10.
• [80]González-Solanellas M, Romagosa Pérez-Portabella A, Zabaleta-del-Olmo E, Grau-Carod M, Casellas-Montagut C, Lancho-Lancho S, et al.: Estudio de prevalencia sobre los hábitos alimentarios y el estado nutricional en población adulta atendida en atención primaria. Nutrición Hospitalaria 2011, 26(2):337-344.
• [81]Hu FB, Rimm E, Smith-Warner SA, Feskanich D, Stampfer MJ, Ascherio A, et al.: Reproducibility and validity of dietary patterns assessed with a food-frequency questionnaire. Am J ClinNutr 1999, 69(2):243-249.
• [82]Schwarzer R, Renner B: Social-cognitive predictors of health behavior: Action self-efficacy and coping self-efficacy. Health Psychol 2000, 19:487-495.
• [83]Luszczynska A, Schwarzer R: Multidimensional health locus of control: comments on the construct and its measurement. J Health Psychol 2005, 10:633-642.
• [84]EuroQol Group: EuroQol: a new facility for the measurement of health related quality of life. Health Policy 1990, 16:199-208.
• [85]Cheung K, Oemar M, Oppe M, Rabin R: EQ-5D User guide. Basic information on how to use EQ-5D. Version 2.0. Rotterdam: EuroQol Group; 2009.
• [86]Van Agt HM, Essink-Bot ML, Krabbe PF, et al.: Test-retest reliability of health state valuations collected with the Euro Qol questionnaire. Soc Sci Med 1994, 39:1537-1544.
• [87]Rabin R, Oemar M, Oppe M: EQ-5D-3 L User Guide. Basic information on how to use the EQ-5D-3 L instrument. Version 4.0. Rotterdam: EuroQol Group; 2011.
• [88]Tanner JM, Whitehouse RH: Clinical longitudinal standards for height, weight, height velocity and stages of puberty. Arch Dis Child 1976, 51:170-179.
• [89]National Healthy Survey from Spain. Cuestionario de menores 2011–2012http://www.msc.es/estadEstudios/estadisticas/encuestaNacional/encuestaNac2011/Cuestionario_Menores.pdf webcite
• [90]National Healthy Survey from Spain. Cuestionario de adultos 2011–2012http://www.msc.es/estadEstudios/estadisticas/encuestaNacional/encuestaNac2011/Cuestionario_Adultos.pdf webcite