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Lowering Blood Pressure by Changing Lifestyle

NCT04505150 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2021-09-23

No results posted yet for this study

Summary

Introduction: 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 and analysis: A single-centre cluster randomized controlled trial (RCT). The study will be conducted for six 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 systolic and diastolic blood pressure. 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, the perceived barriers and enablers to adopt behaviour 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.

Conditions

Interventions

BEHAVIORAL

Lifestyle changes, e.g., take part in regular exercise, quitting smoking, and reduce salt consumption

Intervention participants will receive ongoing counselling with evidence-based information with pictures, fact sheets, published literature about the harmful effect of smoking on hypertension and other cardiovascular diseases for the cessation of smoking and to take part in regular exercise.

Sponsors & Collaborators

  • Swinburne University of Technology

    collaborator OTHER

  • Organisation for Rural Community Development, Bangladesh

    lead OTHER

Principal Investigators

  • Fakir M Amirul Islam, PhD · Organisation for Rural Community Development

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2021-01-31
Completion
2022-12-31

Countries

  • Bangladesh

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04505150 on ClinicalTrials.gov