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Effectiveness of a multifactorial intervention based on an application for smartphones, heart-healthy walks and a nutritional workshop in patients with type 2 diabetes mellitus in primary care (EMID): study protocol for a randomised controlled trial

INTRODUCTION: New information and communication technologies (ICTs) may promote lifestyle changes, but no adequate evidence is available on their combined effect of ICTs with multifactorial interventions aimed at improving diet and increasing physical activity in patients with type 2 diabetes mellit...

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Autores principales: Alonso-Domínguez, Rosario, Gómez-Marcos, Manuel A, Patino-Alonso, Maria C, Sánchez-Aguadero, Natalia, Agudo-Conde, Cristina, Castaño-Sánchez, Carmen, García-Ortiz, Luis, Recio-Rodríguez, José I
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5640135/
https://www.ncbi.nlm.nih.gov/pubmed/28912193
http://dx.doi.org/10.1136/bmjopen-2017-016191
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author Alonso-Domínguez, Rosario
Gómez-Marcos, Manuel A
Patino-Alonso, Maria C
Sánchez-Aguadero, Natalia
Agudo-Conde, Cristina
Castaño-Sánchez, Carmen
García-Ortiz, Luis
Recio-Rodríguez, José I
author_facet Alonso-Domínguez, Rosario
Gómez-Marcos, Manuel A
Patino-Alonso, Maria C
Sánchez-Aguadero, Natalia
Agudo-Conde, Cristina
Castaño-Sánchez, Carmen
García-Ortiz, Luis
Recio-Rodríguez, José I
author_sort Alonso-Domínguez, Rosario
collection PubMed
description INTRODUCTION: New information and communication technologies (ICTs) may promote lifestyle changes, but no adequate evidence is available on their combined effect of ICTs with multifactorial interventions aimed at improving diet and increasing physical activity in patients with type 2 diabetes mellitus (DM2). The primary objective of this study is to assess the effect of a multifactorial intervention to increase physical activity and adherence to Mediterranean diet in DM2. METHODS AND ANALYSIS: Study scope and population: The study will be conducted at ‘La Alamedilla’ primary care research unit in Salamanca (Spain). 200 patients with DM2 of both sexes, aged 25–70 years and who meet the inclusion criteria and sign the informed consent will be recruited. Each participant will attend the clinic at baseline and 3 and 12 months after intervention. INTERVENTION: Both groups will be given short advice on diet and physical activity. The intervention group will also take five heart-healthy walks and attend a group session on diet education and will be trained on use of an application for smartphone (EVIDENT II) for 3 months. VARIABLES AND MEASUREMENT INSTRUMENTS: The main study endpoints will be changes in physical activity, as assessed by a pedometer and the International Physical Activity Questionnaire, and adherence to the Mediterranean diet, as evaluated by an adherence questionnaire and the Diet Quality Index. Anthropometric parameters and laboratory values, lifestyles and quality of life will also be assessed. ETHICS AND DISSEMINATION: It was approved by the Clinical Research Ethics Committee of Salamanca on 28/11/2016. TRIAL REGISTRATION: NCT02991079; Pre-results.
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spelling pubmed-56401352017-10-19 Effectiveness of a multifactorial intervention based on an application for smartphones, heart-healthy walks and a nutritional workshop in patients with type 2 diabetes mellitus in primary care (EMID): study protocol for a randomised controlled trial Alonso-Domínguez, Rosario Gómez-Marcos, Manuel A Patino-Alonso, Maria C Sánchez-Aguadero, Natalia Agudo-Conde, Cristina Castaño-Sánchez, Carmen García-Ortiz, Luis Recio-Rodríguez, José I BMJ Open Medical Education and Training INTRODUCTION: New information and communication technologies (ICTs) may promote lifestyle changes, but no adequate evidence is available on their combined effect of ICTs with multifactorial interventions aimed at improving diet and increasing physical activity in patients with type 2 diabetes mellitus (DM2). The primary objective of this study is to assess the effect of a multifactorial intervention to increase physical activity and adherence to Mediterranean diet in DM2. METHODS AND ANALYSIS: Study scope and population: The study will be conducted at ‘La Alamedilla’ primary care research unit in Salamanca (Spain). 200 patients with DM2 of both sexes, aged 25–70 years and who meet the inclusion criteria and sign the informed consent will be recruited. Each participant will attend the clinic at baseline and 3 and 12 months after intervention. INTERVENTION: Both groups will be given short advice on diet and physical activity. The intervention group will also take five heart-healthy walks and attend a group session on diet education and will be trained on use of an application for smartphone (EVIDENT II) for 3 months. VARIABLES AND MEASUREMENT INSTRUMENTS: The main study endpoints will be changes in physical activity, as assessed by a pedometer and the International Physical Activity Questionnaire, and adherence to the Mediterranean diet, as evaluated by an adherence questionnaire and the Diet Quality Index. Anthropometric parameters and laboratory values, lifestyles and quality of life will also be assessed. ETHICS AND DISSEMINATION: It was approved by the Clinical Research Ethics Committee of Salamanca on 28/11/2016. TRIAL REGISTRATION: NCT02991079; Pre-results. BMJ Publishing Group 2017-09-14 /pmc/articles/PMC5640135/ /pubmed/28912193 http://dx.doi.org/10.1136/bmjopen-2017-016191 Text en © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Medical Education and Training
Alonso-Domínguez, Rosario
Gómez-Marcos, Manuel A
Patino-Alonso, Maria C
Sánchez-Aguadero, Natalia
Agudo-Conde, Cristina
Castaño-Sánchez, Carmen
García-Ortiz, Luis
Recio-Rodríguez, José I
Effectiveness of a multifactorial intervention based on an application for smartphones, heart-healthy walks and a nutritional workshop in patients with type 2 diabetes mellitus in primary care (EMID): study protocol for a randomised controlled trial
title Effectiveness of a multifactorial intervention based on an application for smartphones, heart-healthy walks and a nutritional workshop in patients with type 2 diabetes mellitus in primary care (EMID): study protocol for a randomised controlled trial
title_full Effectiveness of a multifactorial intervention based on an application for smartphones, heart-healthy walks and a nutritional workshop in patients with type 2 diabetes mellitus in primary care (EMID): study protocol for a randomised controlled trial
title_fullStr Effectiveness of a multifactorial intervention based on an application for smartphones, heart-healthy walks and a nutritional workshop in patients with type 2 diabetes mellitus in primary care (EMID): study protocol for a randomised controlled trial
title_full_unstemmed Effectiveness of a multifactorial intervention based on an application for smartphones, heart-healthy walks and a nutritional workshop in patients with type 2 diabetes mellitus in primary care (EMID): study protocol for a randomised controlled trial
title_short Effectiveness of a multifactorial intervention based on an application for smartphones, heart-healthy walks and a nutritional workshop in patients with type 2 diabetes mellitus in primary care (EMID): study protocol for a randomised controlled trial
title_sort effectiveness of a multifactorial intervention based on an application for smartphones, heart-healthy walks and a nutritional workshop in patients with type 2 diabetes mellitus in primary care (emid): study protocol for a randomised controlled trial
topic Medical Education and Training
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5640135/
https://www.ncbi.nlm.nih.gov/pubmed/28912193
http://dx.doi.org/10.1136/bmjopen-2017-016191
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