Comprehensive management of children and adolescents with type 1 diabetes mellitus through personalized physical exercise and education using an mHealth system: The Diactive-1 study protocol

IntroductionThe use of new technologies presents an opportunity to promote physical activity, especially among young people with type 1 diabetes (T1DM), who tend to be less active compared to their healthy counterparts. The aim of this study is to investigate the impact of a personalized resistance...

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Main Authors: Ignacio Hormazábal-Aguayo, Jacinto Muñoz-Pardeza, José Francisco López-Gil, Nidia Huerta-Uribe, María J. Chueca-Guindulain, Sara Berrade-Zubiri, Elisabet Burillo Sánchez, Mikel Izquierdo, Yasmin Ezzatvar, Antonio García-Hermoso
Format: Article
Language:English
Published: Frontiers Media S.A. 2024-02-01
Series:Frontiers in Endocrinology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fendo.2024.1354734/full
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author Ignacio Hormazábal-Aguayo
Jacinto Muñoz-Pardeza
José Francisco López-Gil
Nidia Huerta-Uribe
María J. Chueca-Guindulain
Sara Berrade-Zubiri
Elisabet Burillo Sánchez
Mikel Izquierdo
Yasmin Ezzatvar
Antonio García-Hermoso
author_facet Ignacio Hormazábal-Aguayo
Jacinto Muñoz-Pardeza
José Francisco López-Gil
Nidia Huerta-Uribe
María J. Chueca-Guindulain
Sara Berrade-Zubiri
Elisabet Burillo Sánchez
Mikel Izquierdo
Yasmin Ezzatvar
Antonio García-Hermoso
author_sort Ignacio Hormazábal-Aguayo
collection DOAJ
description IntroductionThe use of new technologies presents an opportunity to promote physical activity, especially among young people with type 1 diabetes (T1DM), who tend to be less active compared to their healthy counterparts. The aim of this study is to investigate the impact of a personalized resistance exercise program, facilitated by the Diactive-1 App, on insulin requirements among children and adolescents diagnosed with T1DM.Methods and analysisA minimum of 52 children and adolescents aged 8-18 years, who were diagnosed with T1DM at least 6 months ago, will be randomly assigned to either a group engaging in an individualized resistance exercise program at least 3 times per week over a 24-week period or a waiting-list control group. The primary outcome will be the daily insulin dose requirement. The secondary outcomes will include glycemic control, cardiometabolic profile, body composition, vascular function, physical fitness, 24-hour movement behaviors, diet, and psychological parameters. The usability of the app will also be assessed.Ethics and disseminationEthical approval to conduct this study has been granted by the University Hospital of Navarra Research Board (PI_2020/140). Parents or legal guardians of minors participating in the study will provide written consent, while children and adolescents will sign an assent form to indicate their voluntary agreement. The trial’s main findings will be shared through conference presentations, peer-reviewed publications, and communication directly with participating families. This study aims to offer valuable insights into the holistic management of children and adolescents with T1DM by utilizing personalized exercise interventions through an mHealth system.Trial registrationNCT06048757
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spelling doaj.art-887cc059e46b48c6a4c12cc3e9f2bc9e2024-02-06T05:02:37ZengFrontiers Media S.A.Frontiers in Endocrinology1664-23922024-02-011510.3389/fendo.2024.13547341354734Comprehensive management of children and adolescents with type 1 diabetes mellitus through personalized physical exercise and education using an mHealth system: The Diactive-1 study protocolIgnacio Hormazábal-Aguayo0Jacinto Muñoz-Pardeza1José Francisco López-Gil2Nidia Huerta-Uribe3María J. Chueca-Guindulain4Sara Berrade-Zubiri5Elisabet Burillo Sánchez6Mikel Izquierdo7Yasmin Ezzatvar8Antonio García-Hermoso9Navarrabiomed, Hospital Universitario de Navarra (HUN), Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, SpainNavarrabiomed, Hospital Universitario de Navarra (HUN), Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, SpainOne Health Research Group, Universidad de Las Américas, Quito, EcuadorNavarrabiomed, Hospital Universitario de Navarra (HUN), Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, SpainPediatric Endocrinology Unit, Hospital Universitario de Navarra (HUN), IdiSNA, Pamplona, SpainPediatric Endocrinology Unit, Hospital Universitario de Navarra (HUN), IdiSNA, Pamplona, SpainPediatric Endocrinology Unit, Hospital Universitario de Navarra (HUN), IdiSNA, Pamplona, SpainNavarrabiomed, Hospital Universitario de Navarra (HUN), Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, SpainDepartment of Nursing, Universitat de València, Valencia, SpainNavarrabiomed, Hospital Universitario de Navarra (HUN), Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, SpainIntroductionThe use of new technologies presents an opportunity to promote physical activity, especially among young people with type 1 diabetes (T1DM), who tend to be less active compared to their healthy counterparts. The aim of this study is to investigate the impact of a personalized resistance exercise program, facilitated by the Diactive-1 App, on insulin requirements among children and adolescents diagnosed with T1DM.Methods and analysisA minimum of 52 children and adolescents aged 8-18 years, who were diagnosed with T1DM at least 6 months ago, will be randomly assigned to either a group engaging in an individualized resistance exercise program at least 3 times per week over a 24-week period or a waiting-list control group. The primary outcome will be the daily insulin dose requirement. The secondary outcomes will include glycemic control, cardiometabolic profile, body composition, vascular function, physical fitness, 24-hour movement behaviors, diet, and psychological parameters. The usability of the app will also be assessed.Ethics and disseminationEthical approval to conduct this study has been granted by the University Hospital of Navarra Research Board (PI_2020/140). Parents or legal guardians of minors participating in the study will provide written consent, while children and adolescents will sign an assent form to indicate their voluntary agreement. The trial’s main findings will be shared through conference presentations, peer-reviewed publications, and communication directly with participating families. This study aims to offer valuable insights into the holistic management of children and adolescents with T1DM by utilizing personalized exercise interventions through an mHealth system.Trial registrationNCT06048757https://www.frontiersin.org/articles/10.3389/fendo.2024.1354734/fullinsulin-dependent diabetes mellitusphysical exerciseresistance trainingmobile-healthpediatrics
spellingShingle Ignacio Hormazábal-Aguayo
Jacinto Muñoz-Pardeza
José Francisco López-Gil
Nidia Huerta-Uribe
María J. Chueca-Guindulain
Sara Berrade-Zubiri
Elisabet Burillo Sánchez
Mikel Izquierdo
Yasmin Ezzatvar
Antonio García-Hermoso
Comprehensive management of children and adolescents with type 1 diabetes mellitus through personalized physical exercise and education using an mHealth system: The Diactive-1 study protocol
Frontiers in Endocrinology
insulin-dependent diabetes mellitus
physical exercise
resistance training
mobile-health
pediatrics
title Comprehensive management of children and adolescents with type 1 diabetes mellitus through personalized physical exercise and education using an mHealth system: The Diactive-1 study protocol
title_full Comprehensive management of children and adolescents with type 1 diabetes mellitus through personalized physical exercise and education using an mHealth system: The Diactive-1 study protocol
title_fullStr Comprehensive management of children and adolescents with type 1 diabetes mellitus through personalized physical exercise and education using an mHealth system: The Diactive-1 study protocol
title_full_unstemmed Comprehensive management of children and adolescents with type 1 diabetes mellitus through personalized physical exercise and education using an mHealth system: The Diactive-1 study protocol
title_short Comprehensive management of children and adolescents with type 1 diabetes mellitus through personalized physical exercise and education using an mHealth system: The Diactive-1 study protocol
title_sort comprehensive management of children and adolescents with type 1 diabetes mellitus through personalized physical exercise and education using an mhealth system the diactive 1 study protocol
topic insulin-dependent diabetes mellitus
physical exercise
resistance training
mobile-health
pediatrics
url https://www.frontiersin.org/articles/10.3389/fendo.2024.1354734/full
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