Treatment of Childhood Obesity Based on Brazilian Dietary Guidelines Plus Energy Restriction (PAPPAS HUPE Study): Protocol for a Randomized Clinical Trial

BACKGROUND: The Food Guide for the Brazilian Population relies on natural or minimally processed foods mainly of plant origin such as beans and rice with low oil, salt, and sugar content and limited consumption of ultraprocessed foods. Reduction of ultraprocessed foods improves diet quality and energy consumption. OBJECTIVE: The goal of this study is to evaluate the effectiveness of an intervention for the treatment of obesity in children, with counseling based on the Brazilian Food Guide plus control of total energy intake. METHODS: A parallel, randomized clinical trial will include children aged 7 to 12 years. Randomization will be performed in blocks of 10 individuals using computer-generated random sequence numbers. Both the control and intervention groups will participate in 6 standardized educational activities based on the 10 steps of the Brazilian Food Guide. These activities will be conducted at the University Hospital Toy Library, located in the pediatric outpatient clinic. For the intervention group, in addition to the educational activities, an individualized food plan based on the nutritional recommendations of the Brazilian Society of Pediatrics will be prescribed and discussed with the mothers and fathers. The primary outcome of the study will be variations in body mass index, and secondary outcomes will include analysis of insulin resistance, blood pressure, body fat percentage, and waist and neck circumference. RESULTS: This project was funded by the National Council for Scientific and Technological Development in December 2017 (grant no 408333/2017-0). Recruitment began in August 2018 and by September 2019, we had enrolled the 101 participants. In addition to the patients referred by the national system of regulation, recruitment was made by medical outpatient referral and external indication. This is an ongoing study. We expect the results to be published in November 2020. CONCLUSIONS: At the end of the project, in case of a positive result, a protocol for the treatment of obesity based on the Brazilian Food Guide will be proposed to the Unified Health System. A successful method to reduce childhood obesity is expected. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials RBR-3st5sn; http://www.ensaiosclinicos.gov.br/rg/RBR-3st5sn INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16170