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

Fakir M Amirul Islam, Elisabeth A Lambert, Sheikh Mohammed Shariful Islam, M Ariful Islam, Dip Biswas, Rachael McDonald, Ralph Maddison, Bruce Thompson, Gavin W Lambert, Fakir M Amirul Islam, Elisabeth A Lambert, Sheikh Mohammed Shariful Islam, M Ariful Islam, Dip Biswas, Rachael McDonald, Ralph Maddison, Bruce Thompson, Gavin W Lambert

Abstract

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.

Conflict of interest statement

The authors declare that they have no competing interests. The authors have approved its submission.

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