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Lowering blood pressure by changing lifestyle through a motivational education program: a cluster randomized controlled trial study protocol

BACKGROUND: High blood pressure is an independent risk factor of cardiovascular disease (CVD) and is a major cause of disability and death. Managing a healthy lifestyle has been shown to reduce blood pressure and improve health outcomes. We aim to investigate the effectiveness of a lifestyle modific...

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Autores principales: Islam, Fakir M Amirul, Lambert, Elisabeth A., Islam, Sheikh Mohammed Shariful, Islam, M. Ariful, Biswas, Dip, McDonald, Rachael, Maddison, Ralph, Thompson, Bruce, Lambert, Gavin W.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8264477/
https://www.ncbi.nlm.nih.gov/pubmed/34238363
http://dx.doi.org/10.1186/s13063-021-05379-2
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author Islam, Fakir M Amirul
Lambert, Elisabeth A.
Islam, Sheikh Mohammed Shariful
Islam, M. Ariful
Biswas, Dip
McDonald, Rachael
Maddison, Ralph
Thompson, Bruce
Lambert, Gavin W.
author_facet Islam, Fakir M Amirul
Lambert, Elisabeth A.
Islam, Sheikh Mohammed Shariful
Islam, M. Ariful
Biswas, Dip
McDonald, Rachael
Maddison, Ralph
Thompson, Bruce
Lambert, Gavin W.
author_sort Islam, Fakir M Amirul
collection PubMed
description BACKGROUND: High blood pressure is an independent risk factor of cardiovascular disease (CVD) and is a major cause of disability and death. Managing a healthy lifestyle has been shown to reduce blood pressure and improve health outcomes. We aim to investigate the effectiveness of a lifestyle modification intervention program for lowering blood pressure in a rural area of Bangladesh. METHODS: A single-center cluster randomized controlled trial (RCT). The study will be conducted for 6 months, a total of 300 participants of age 30 to 75 years with 150 adults in each of the intervention and the control arms. The intervention arm will involve the delivery of a blended learning education program on lifestyle changes for the management of high blood pressure. The education program comprises evidence-based information with pictures, fact sheets, and published literature about the effects of high blood pressure on CVD development, increased physical activity, and the role of a healthy diet in blood pressure management. The control group involves providing information booklets and general advice at the baseline data collection point. The primary outcome will be the absolute difference in clinic SBP and DBP. Secondary outcomes include the difference in the percentage of people adopting regular exercise habits, cessation of smoking and reducing sodium chloride intake, health literacy of all participants, and the perceived barriers and enablers to adopt behavior changes by collecting qualitative data. Analyses will include analysis of covariance to report the mean difference in blood pressure between the control and the intervention group and the difference in change in blood pressure due to the intervention. DISCUSSION: The study will assess the effects of physical activity and lifestyle modification in controlling high blood pressure. This study will develop new evidence as to whether a simple lifestyle program implemented in a rural region of a low- and middle-income country will improve blood pressure parameters for people with different chronic diseases by engaging community people. TRIAL REGISTRATION: ClinicalTrials.gov NCT04505150. Registered on 7 August 2020
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spelling pubmed-82644772021-07-08 Lowering blood pressure by changing lifestyle through a motivational education program: a cluster randomized controlled trial study protocol Islam, Fakir M Amirul Lambert, Elisabeth A. Islam, Sheikh Mohammed Shariful Islam, M. Ariful Biswas, Dip McDonald, Rachael Maddison, Ralph Thompson, Bruce Lambert, Gavin W. Trials Study Protocol BACKGROUND: High blood pressure is an independent risk factor of cardiovascular disease (CVD) and is a major cause of disability and death. Managing a healthy lifestyle has been shown to reduce blood pressure and improve health outcomes. We aim to investigate the effectiveness of a lifestyle modification intervention program for lowering blood pressure in a rural area of Bangladesh. METHODS: A single-center cluster randomized controlled trial (RCT). The study will be conducted for 6 months, a total of 300 participants of age 30 to 75 years with 150 adults in each of the intervention and the control arms. The intervention arm will involve the delivery of a blended learning education program on lifestyle changes for the management of high blood pressure. The education program comprises evidence-based information with pictures, fact sheets, and published literature about the effects of high blood pressure on CVD development, increased physical activity, and the role of a healthy diet in blood pressure management. The control group involves providing information booklets and general advice at the baseline data collection point. The primary outcome will be the absolute difference in clinic SBP and DBP. Secondary outcomes include the difference in the percentage of people adopting regular exercise habits, cessation of smoking and reducing sodium chloride intake, health literacy of all participants, and the perceived barriers and enablers to adopt behavior changes by collecting qualitative data. Analyses will include analysis of covariance to report the mean difference in blood pressure between the control and the intervention group and the difference in change in blood pressure due to the intervention. DISCUSSION: The study will assess the effects of physical activity and lifestyle modification in controlling high blood pressure. This study will develop new evidence as to whether a simple lifestyle program implemented in a rural region of a low- and middle-income country will improve blood pressure parameters for people with different chronic diseases by engaging community people. TRIAL REGISTRATION: ClinicalTrials.gov NCT04505150. Registered on 7 August 2020 BioMed Central 2021-07-08 /pmc/articles/PMC8264477/ /pubmed/34238363 http://dx.doi.org/10.1186/s13063-021-05379-2 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Islam, Fakir M Amirul
Lambert, Elisabeth A.
Islam, Sheikh Mohammed Shariful
Islam, M. Ariful
Biswas, Dip
McDonald, Rachael
Maddison, Ralph
Thompson, Bruce
Lambert, Gavin W.
Lowering blood pressure by changing lifestyle through a motivational education program: a cluster randomized controlled trial study protocol
title Lowering blood pressure by changing lifestyle through a motivational education program: a cluster randomized controlled trial study protocol
title_full Lowering blood pressure by changing lifestyle through a motivational education program: a cluster randomized controlled trial study protocol
title_fullStr Lowering blood pressure by changing lifestyle through a motivational education program: a cluster randomized controlled trial study protocol
title_full_unstemmed Lowering blood pressure by changing lifestyle through a motivational education program: a cluster randomized controlled trial study protocol
title_short Lowering blood pressure by changing lifestyle through a motivational education program: a cluster randomized controlled trial study protocol
title_sort lowering blood pressure by changing lifestyle through a motivational education program: a cluster randomized controlled trial study protocol
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8264477/
https://www.ncbi.nlm.nih.gov/pubmed/34238363
http://dx.doi.org/10.1186/s13063-021-05379-2
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