A multicomponent family intervention, combined with salt reduction for children with obesity: a factorial randomized study protocol

Abstract Background Clinical trials to treat childhood obesity show modest results, weight regain and high dropout rates. Children with obesity often live in families with habits that contribute to unhealthy weight gain. This study will test whether a family intervention with a Brazilian-adapted Pla...

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Main Authors: Cinthia Guimarães Assemany, Diana Barbosa Cunha, Joana Maia Brandão, Vitor Barreto Paravidino, Magno Conceição Garcia, Ana Lúcia Viégas Rêgo, Rosangela Alves Pereira, Rosely Sichieri
Format: Article
Language:English
Published: BMC 2023-07-01
Series:BMC Public Health
Subjects:
Online Access:https://doi.org/10.1186/s12889-023-16356-6
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author Cinthia Guimarães Assemany
Diana Barbosa Cunha
Joana Maia Brandão
Vitor Barreto Paravidino
Magno Conceição Garcia
Ana Lúcia Viégas Rêgo
Rosangela Alves Pereira
Rosely Sichieri
author_facet Cinthia Guimarães Assemany
Diana Barbosa Cunha
Joana Maia Brandão
Vitor Barreto Paravidino
Magno Conceição Garcia
Ana Lúcia Viégas Rêgo
Rosangela Alves Pereira
Rosely Sichieri
author_sort Cinthia Guimarães Assemany
collection DOAJ
description Abstract Background Clinical trials to treat childhood obesity show modest results, weight regain and high dropout rates. Children with obesity often live in families with habits that contribute to unhealthy weight gain. This study will test whether a family intervention with a Brazilian-adapted Planetary Healthy Diet (PHD) and reduced portion sizes, along with increased physical activity and reduced sedentary behavior, can reduce excessive weight gain. The protocol promotes the intake of in natura products and water and reduces ultra-processed foods, sugar, and sodium. It encourages family lifestyle changes and physical activities, with randomized allocation to experimental and control groups. The responsible family member will be evaluated during follow-up. The control group will receive a print of the Brazilian dietary guideline. Methods A factorial crossover design will also allocate families to receive reduced sodium salt plus anti-inflammatory herbs and a placebo salt. Both the control and intervention groups will be randomly assigned to the sequence of both salts. The approach aims to reduce body weight expectations and evaluate salt's impact on blood pressure. It includes a 1-month intervention, 1-month washout, and 1-month intervention with monthly clinic visits and teleservice by health professionals. The primary outcomes will be the variation in the Body Mass Index (BMI) of the children. BMI and the variation in the blood pressure of the pair (child/mother or father) as well as waist circumference (WC) and waist-to-height ratio (WHtR) will also be measured. Discussion The project will test the effectiveness of the use of the recommendations of the PHD, physical activity and a salt-reduced sodium. The results of the present study will allow the refinement of interventions aimed at the treatment of childhood obesity and may help develop guidelines for the treatment of obesity in Brazilian children. Trial registration The study is registered in the Brazilian Registry of Clinical Trials (RBR-10 mm62vs). Registered 10 February 2023.
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spelling doaj.art-dd8b371dcbdb42bda36e71204c178c6a2023-07-30T11:26:08ZengBMCBMC Public Health1471-24582023-07-0123111010.1186/s12889-023-16356-6A multicomponent family intervention, combined with salt reduction for children with obesity: a factorial randomized study protocolCinthia Guimarães Assemany0Diana Barbosa Cunha1Joana Maia Brandão2Vitor Barreto Paravidino3Magno Conceição Garcia4Ana Lúcia Viégas Rêgo5Rosangela Alves Pereira6Rosely Sichieri7Department of Epidemiology, Institute of Social Medicine, State University of Rio de JaneiroDepartment of Epidemiology, Institute of Social Medicine, State University of Rio de JaneiroDepartment of Epidemiology, Institute of Social Medicine, State University of Rio de JaneiroDepartment of Epidemiology, Institute of Social Medicine, State University of Rio de JaneiroDepartment of Epidemiology, Institute of Social Medicine, State University of Rio de JaneiroDepartment of Epidemiology, Institute of Social Medicine, State University of Rio de JaneiroDepartment of Social and Applied Nutrition, Federal University of Rio de JaneiroDepartment of Epidemiology, Institute of Social Medicine, State University of Rio de JaneiroAbstract Background Clinical trials to treat childhood obesity show modest results, weight regain and high dropout rates. Children with obesity often live in families with habits that contribute to unhealthy weight gain. This study will test whether a family intervention with a Brazilian-adapted Planetary Healthy Diet (PHD) and reduced portion sizes, along with increased physical activity and reduced sedentary behavior, can reduce excessive weight gain. The protocol promotes the intake of in natura products and water and reduces ultra-processed foods, sugar, and sodium. It encourages family lifestyle changes and physical activities, with randomized allocation to experimental and control groups. The responsible family member will be evaluated during follow-up. The control group will receive a print of the Brazilian dietary guideline. Methods A factorial crossover design will also allocate families to receive reduced sodium salt plus anti-inflammatory herbs and a placebo salt. Both the control and intervention groups will be randomly assigned to the sequence of both salts. The approach aims to reduce body weight expectations and evaluate salt's impact on blood pressure. It includes a 1-month intervention, 1-month washout, and 1-month intervention with monthly clinic visits and teleservice by health professionals. The primary outcomes will be the variation in the Body Mass Index (BMI) of the children. BMI and the variation in the blood pressure of the pair (child/mother or father) as well as waist circumference (WC) and waist-to-height ratio (WHtR) will also be measured. Discussion The project will test the effectiveness of the use of the recommendations of the PHD, physical activity and a salt-reduced sodium. The results of the present study will allow the refinement of interventions aimed at the treatment of childhood obesity and may help develop guidelines for the treatment of obesity in Brazilian children. Trial registration The study is registered in the Brazilian Registry of Clinical Trials (RBR-10 mm62vs). Registered 10 February 2023.https://doi.org/10.1186/s12889-023-16356-6Pediatric obesityDietHealthyMedicinal herbsDietSodium-restricted
spellingShingle Cinthia Guimarães Assemany
Diana Barbosa Cunha
Joana Maia Brandão
Vitor Barreto Paravidino
Magno Conceição Garcia
Ana Lúcia Viégas Rêgo
Rosangela Alves Pereira
Rosely Sichieri
A multicomponent family intervention, combined with salt reduction for children with obesity: a factorial randomized study protocol
BMC Public Health
Pediatric obesity
Diet
Healthy
Medicinal herbs
Diet
Sodium-restricted
title A multicomponent family intervention, combined with salt reduction for children with obesity: a factorial randomized study protocol
title_full A multicomponent family intervention, combined with salt reduction for children with obesity: a factorial randomized study protocol
title_fullStr A multicomponent family intervention, combined with salt reduction for children with obesity: a factorial randomized study protocol
title_full_unstemmed A multicomponent family intervention, combined with salt reduction for children with obesity: a factorial randomized study protocol
title_short A multicomponent family intervention, combined with salt reduction for children with obesity: a factorial randomized study protocol
title_sort multicomponent family intervention combined with salt reduction for children with obesity a factorial randomized study protocol
topic Pediatric obesity
Diet
Healthy
Medicinal herbs
Diet
Sodium-restricted
url https://doi.org/10.1186/s12889-023-16356-6
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