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

BACKGROUNDPediatric 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/DESIGNThe 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. DISCUSSIONTo 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.