基于巴西饮食指南加能量限制的儿童肥胖治疗（PAPPAS HUPE研究）：一项随机临床试验方案

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

作者信息

Brandao Joana Maia, Sichieri Rosely, Ribas Simone Augusta, Verly-Jr Eliseu, Pereira Rosangela Alves, Castro Inês Rugani Ribeiro De, Hassan Bruna Kulik, Oliveira Alessandra Silva Dias De, Marques Emanuele Souza, Cunha Diana Barbosa

机构信息

Department of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro, Rio de Janeiro, Brazil.

Department of Nutrition and Public Health, School of Nutrition, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.

出版信息

JMIR Res Protoc. 2020 Jun 8;9(6):e16170. doi: 10.2196/16170.

DOI:10.2196/16170

PMID:32502969

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7308900/

Abstract

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.

摘要

背景

巴西人群饮食指南依赖主要源自植物的天然或最低限度加工食品，如豆类和大米，其油、盐和糖含量低，超加工食品的消费量有限。减少超加工食品可改善饮食质量和能量消耗。

目的

本研究的目的是评估基于巴西饮食指南进行咨询并控制总能量摄入的干预措施对儿童肥胖治疗的有效性。

方法

一项平行随机临床试验将纳入7至12岁的儿童。使用计算机生成的随机序列号按10人一组进行随机分组。对照组和干预组都将参加基于巴西饮食指南10个步骤的6项标准化教育活动。这些活动将在位于儿科门诊的大学医院玩具图书馆开展。对于干预组，除教育活动外，还将根据巴西儿科学会的营养建议制定个性化饮食计划，并与父母进行讨论。该研究的主要结局将是体重指数的变化，次要结局将包括胰岛素抵抗、血压、体脂百分比以及腰围和颈围的分析。

结果

该项目于2017年12月获得国家科学技术发展委员会资助（资助编号408333/2017 - 0）。招募工作于2018年8月开始，到2019年9月，我们已招募了101名参与者。除了国家监管系统转诊来的患者外，还通过医疗门诊转诊和外部推荐进行招募。这是一项正在进行的研究。我们预计结果将于2020年11月发表。