ENTREN-F family-system based intervention for managing childhood obesity: Study protocol for a randomized controlled trial at primary care
Marta Rojo, Tatiana Lacruz, Santos Solano, Mario Vivar, Andrea Del Río, Jone Martínez, Sara Foguet, Marta Marín, Alba Moreno-Encinas, Óscar Luis Veiga, Verónica Cabanas, Consuelo Rey, Montserrat Graell, Ana Rosa Sepúlveda, Marta Rojo, Tatiana Lacruz, Santos Solano, Mario Vivar, Andrea Del Río, Jone Martínez, Sara Foguet, Marta Marín, Alba Moreno-Encinas, Óscar Luis Veiga, Verónica Cabanas, Consuelo Rey, Montserrat Graell, Ana Rosa Sepúlveda
Abstract
Background: Pediatric obesity is a primary public health concern, and designing effective programs for managing it is of the utmost importance. The objective of this study was to describe the protocol study of a three-arm, parallel, randomized controlled trial aimed at assessing the efficacy of a family-system-based intervention ("ENTREN-F" program) for managing childhood obesity, compared to the "ENTREN" program (no "F" - without specific family-system-based workshop) and a control group (behavioral monitoring).
Methods/design: The ENTREN-F program was a multicomponent family-system-based intervention carried out by a multidisciplinary team in the primary health care setting. The program targeted children between 8 and 12 years with overweight and obesity (P ≥ 85th). Parents were actively involved in the process. The contents were designed using the Cognitive Behavioral Therapy (CBT) principles. The program comprised individual behavioral monitoring, a healthy habits workshop for children and their parents, a CBT workshop for children, and a family-system-based workshop for parents, enhancing parental management skills plus family functioning. The trial's primary outcomes included changes in child body mass index (BMI) z-scores, child's psychological well-being, and family functioning over six months. Secondary outcomes included changes in eating behavior, physical activity, self-esteem, parental distress, parental feeding practices, and parental modeling.
Discussion: To our knowledge, this is one of the few randomized controlled trials to assess the efficacy of a multicomponent program that considers health from a comprehensive perspective, trying to improve children's psychological well-being and family functioning besides weight loss. This study, therefore, addresses a gap in the literature. If found to be efficacious, it suggests a new potential health service for translation into National Primary Health Care services in Spain, one of the ten countries with the highest prevalence of obesity in Europe.
Keywords: Childhood obesity; Family-based intervention; Family-system-based intervention; Primary care; Randomized controlled trial; Study protocol.
Conflict of interest statement
Conflict of interest No authors have any competing interests.
Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.
Source: PubMed