Efficacy of a digital intervention to promote the Brazilian diet on diseases prevention: the PREDIBRA clinical trial

• Grant number: 24/23129-3
• Support Opportunities: Regular Research Grants
• Start date: October 01, 2025
• End date: September 30, 2028
• Field of knowledge: Health Sciences - Nutrition - Nutritional Analysis of Population
• Principal Investigator: Maria Laura da Costa Louzada
• Grantee: Maria Laura da Costa Louzada
• Host Institution: Faculdade de Saúde Pública (FSP). Universidade de São Paulo (USP). São Paulo , SP, Brazil
• City of the host institution: São Paulo
• Associated researchers: AMANDA CRISTINA DA SILVA DE JESUS ; Ana Correa ruiz ; Ana Maria Pandolfo Feoli ; Carlos Augusto Monteiro ; Juliana Giaj Levra de Jesus ; Kamila Tiemann Gabe ; Laura Virgili Claro ; Luisa Gazola Lage ; Marthina Streda Walker ; Patricia Constante Jaime ; Renata Bertazzi Levy ; Rosane Marques Augusto Santana ; Sabrina Dalbosco Gadenz
• Associated scholarship(s): 25/21619-6 - Development and implementation of a nutritional care protocol for teleconsultations: training, supervision, and monitoring of an intervention, BP.DR

Abstract

Introduction: The Brazilian Dietary Guidelines recommend avoiding ultra-processed foods and promoting fresh or minimally processed foods and their culinary preparations as the foundation of a healthy diet. Despite the relevance of this document, there is a lack of experimental studies evaluating the effect of adherence to the diet proposed by the Guidelines in preventing risk factors for non-communicable chronic diseases. This project aims to conduct the study "PREDIBRA: Prevention of Diseases with the Brazilian Diet," a randomized clinical trial designed to evaluate the effectiveness of a digital intervention promoting the Brazilian diet proposed by the Guidelines in preventing health outcomes among adult participants of the NutriNet Brasil cohort. Methods: Randomized clinical trial. The intervention will last six months and consist of a healthy eating promotion program based on the Dietary Guidelines, delivered through a mobile application combined with monthly teleconsultations with nutritionists. A sub-sample of participants from the NutriNet Brasil cohort (n=2760) will be recruited and randomized into four arms: two intervention groups (1 - app + teleconsultations and 2 - app only) and two control groups (1 - app without dietary messages and 2 - no intervention). The study's primary outcome is change in body weight. Secondary outcomes include changes in depressive symptoms, dietary knowledge regarding food processing levels, adherence to dietary practices associated with healthy eating, and adherence to the Brazilian diet proposed by the Guidelines. Outcomes will be assessed mid-intervention (3 months), immediately post-intervention (6 months), and six months after the intervention ends (12 months). Dissemination and Evaluation: The study will provide evidence on the causal relationship between the diet proposed by the Dietary Guidelines and health outcomes. The digital health intervention developed may be made available to the Ministry of Health for integration into Brazil's Unified Health System (SUS). (AU)