The Obemat2.0 Study: A Clinical Trial of a Motivational Intervention for Childhood Obesity Treatment.

Carme Rubio-Torrents, Ricardo Closa-Monasterolo, Priya Singh, Michelle Venables, Francesc Arasa, Clara Alegret-Basora, Pablo Hsu, Josep M Basora, Raimon Ferré, Mireia Alcázar, Mercè Núñez-Roig, Veronica Luque, Mariona Gispert-Llauradó, Marta Zaragoza-Jordana, Judit Muñoz-Hernando, Núria Guillen, Desirée Gutiérrez-Marín, Raquel Monné, Gemma Flores, Natalia Ferré, Joaquín Escribano, Albert Feliu

Journal: Nutrients 2019;11(2):419

PMID: 30781525

Plain Language Summary

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Multicomponent interventions consisting of dietary modification, physical activity, behavioural therapy, and education have shown to improve body mass index, blood pressure, and lipids profile. The Obemat2.0 trail was designed and conducted to implement and to test the efficacy of a structured multicomponent motivational therapy to treat childhood obesity. The study is a randomised clustered clinical trial with a treatment on children with obesity lasting 12 months. The study had two arms: a control group and an intervention group. The recruitment started in June 2016 and the fieldwork is expected to end in June 2019. The study results will show whether a multicomponent program, including a bundle of motivational strategies conducted in primary centres by therapists with 12h of specific training could be more effective than usual care. Authors expect this clinical trial to open a window of opportunity to support professionals at the primary care level to treat childhood obesity.

Abstract

The primary aim of the Obemat2.0 trial was to evaluate the efficacy of a multicomponent motivational program for the treatment of childhood obesity, coordinated between primary care and hospital specialized services, compared to the usual intervention performed in primary care. This was a cluster randomized clinical trial conducted in Spain, with two intervention arms: motivational intervention group vs. usual care group (as control), including 167 participants in each. The motivational intervention consisted of motivational interviewing, educational materials, use of an eHealth physical activity monitor and three group-based sessions. The primary outcome was body mass index (BMI) z score increments before and after the 12 (+3) months of intervention. Secondary outcomes (pre-post intervention) were: adherence to treatment, waist circumference (cm), fat mass index (z score), fat free mass index (z score), total body water (kg), bone mineral density (z score), blood lipids profile, glucose metabolism, and psychosocial problems. Other assessments (pre and post-intervention) were: sociodemographic information, physical activity, sedentary activity, neuropsychological testing, perception of body image, quality of the diet, food frequency consumption and foods available at home. The results of this clinical trial could open a window of opportunity to support professionals at the primary care to treat childhood obesity. The clinicaltrials.gov identifier was NCT02889406.

Address: Pediatric Nutrition and Human Development Research Unit, Universitat Rovira i Virgili, IISPV, 43201 Reus, Spain. [email protected].; Hospital Universitari de Tarragona Joan XXIII, 43007 Tarragona, Spain. [email protected].; Pediatric Nutrition and Human Development Research Unit, Universitat Rovira i Virgili, IISPV, 43201 Reus, Spain. [email protected].; Hospital Universitari Sant Joan de Reus, 43204 Reus, Spain. [email protected].; Pediatric Nutrition and Human Development Research Unit, Universitat Rovira i Virgili, IISPV, 43201 Reus, Spain. [email protected].; Hospital Universitari Sant Joan de Reus, 43204 Reus, Spain. [email protected].; Pediatric Nutrition and Human Development Research Unit, Universitat Rovira i Virgili, IISPV, 43201 Reus, Spain. [email protected].; Unitat de Suport a la Recerca Tarragona-Reus, IDIAPJGol, 43204 Reus, Spain. [email protected].; Pediatric Nutrition and Human Development Research Unit, Universitat Rovira i Virgili, IISPV, 43201 Reus, Spain. [email protected].; Unitat de Suport a la Recerca Tarragona-Reus, IDIAPJGol, 43204 Reus, Spain. [email protected].; Pediatric Nutrition and Human Development Research Unit, Universitat Rovira i Virgili, IISPV, 43201 Reus, Spain. [email protected].; Pediatric Nutrition and Human Development Research Unit, Universitat Rovira i Virgili, IISPV, 43201 Reus, Spain. [email protected].; Hospital Universitari Sant Joan de Reus, 43204 Reus, Spain. [email protected].; Pediatric Nutrition and Human Development Research Unit, Universitat Rovira i Virgili, IISPV, 43201 Reus, Spain. [email protected].; Pediatric Nutrition and Human Development Research Unit, Universitat Rovira i Virgili, IISPV, 43201 Reus, Spain. [email protected].; Pediatric Nutrition and Human Development Research Unit, Universitat Rovira i Virgili, IISPV, 43201 Reus, Spain. [email protected].; Pediatric Nutrition and Human Development Research Unit, Universitat Rovira i Virgili, IISPV, 43201 Reus, Spain. [email protected].; Pediatric Nutrition and Human Development Research Unit, Universitat Rovira i Virgili, IISPV, 43201 Reus, Spain. [email protected].; Pediatric Nutrition and Human Development Research Unit, Universitat Rovira i Virgili, IISPV, 43201 Reus, Spain. [email protected].; Hospital Universitari Sant Joan de Reus, 43204 Reus, Spain. [email protected].; Unitat de Suport a la Recerca Tarragona-Reus, IDIAPJGol, 43204 Reus, Spain. [email protected].; Unitat de Suport a la Recerca Tarragona-Reus, IDIAPJGol, 43204 Reus, Spain. [email protected].; Hospital Universitari Sant Joan de Reus, 43204 Reus, Spain. [email protected].; Unitat de Suport a la Recerca Tarragona-Reus, IDIAPJGol, 43204 Reus, Spain. [email protected].; Hospital Verge de la Cinta, 43500 Tortosa, Tarragona, Spain. [email protected].; MRC Elsie Widdowson laboratory, Cambridge CB1 9NL, UK. [email protected].; MRC Elsie Widdowson laboratory, Cambridge CB1 9NL, UK. [email protected].; Pediatric Nutrition and Human Development Research Unit, Universitat Rovira i Virgili, IISPV, 43201 Reus, Spain. [email protected].; Hospital Universitari de Tarragona Joan XXIII, 43007 Tarragona, Spain. [email protected].
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