Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 6, 2019
Date Accepted: Nov 13, 2019
Date Submitted to PubMed: Jun 5, 2020
Randomized clinical trial for the treatment of childhood obesity based on Brazilian dietary guidelines plus energy restriction: PAPPAS HUPE study protocol
ABSTRACT
Background:
The Food Guide for the Brazilian Population rely 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 ultra-processed foods. Reduction of ultra-processed 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 with children between 7 and 12 years of age. 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 their mothers/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 (CNPQ) in December 2017 (grant no.: 408333/2017-0). As of September 2019, we enrolled 101 participants. This is a ongoing study, we expected results to be published in april 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 for the Unified Health System. Clinical Trial: This trial is registered at the Brazilian Registry of Clinical Trials (REBEC), under the RBR-3st5sn registry, available at http://www.ensaiosclinicos.gov.br/rg/RBR-3st5sn/.
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