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

doi:10.1016/j.orcp.2022.07.001

ENTREN-F family-system based intervention for managing childhood obesity: Study protocol for a randomized controlled trial at primary care

Obes Res Clin Pract. 2022 Jul-Aug;16(4):319-329. doi: 10.1016/j.orcp.2022.07.001. Epub 2022 Jul 22.

Affiliations

¹ Department of Biological and Health Psychology, Faculty of Psychology (Department of Biological and Clinical Psychology), Autonomous University of Madrid, Spain. Electronic address: marta.rojo@uam.es.
² Department of Biological and Health Psychology, Faculty of Psychology (Department of Biological and Clinical Psychology), Autonomous University of Madrid, Spain.
³ Department of Physical Education, Sport & Human Motricity, Faculty of Teacher Training and Education, Autonomous University of Madrid, Spain.
⁴ Valdelasfuentes Primary Health Care Center (Alcobendas), Public Health System from Madrid, Spain.
⁵ Child and Adolescent Psychiatry and Psychology Department, University Hospital Niño Jesús, Centro de Investigación Biomédica en Red de SaludMental (CIBERSAM), Madrid, Spain.
⁶ Department of Biological and Health Psychology, Faculty of Psychology (Department of Biological and Clinical Psychology), Autonomous University of Madrid, Spain. Electronic address: anarosa.sepulveda@uam.es.

PMID: 35871907
DOI: 10.1016/j.orcp.2022.07.001

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.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Body Mass Index
Child
Exercise
Humans
Parents / psychology
Pediatric Obesity* / prevention & control
Primary Health Care
Randomized Controlled Trials as Topic