Lowering Blood Pressure by Changing Lifestyle

NCT04505150 | Unknown

• 1 other identifier: LBP2723
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

High Blood Pressure

Keywords

lifestyle; health literacy; cluster RCT; physical exercise; smoking

Outcome Measures

Primary Outcomes (1)

• Change in systolic and diastolic blood pressure in mmHg

  Data at baselie will be compared between the control and intervention arms; change will be computed from the difference between three and six months from baseline measures and will be compared between and within groups. Omron blood pressure measuring tool will be used.

  1. Baseline, 2. during the intervention (3 months) and 3. Immediately after the intervention (six months)

Secondary Outcomes (7)

• Evaluation of the psychometric properties of a Health literacy tool, European Health Literacy Survey Questionnaire (HLS-Q12) in rural Bangladesh.

  Baseline

• Assesment of the level of health literacy using health related scale European Health Literacy Survey Questionnaire

  1. Baseline and 2. Immediately after the intervention (six months)

• Barriers and enablers in managing healthy lifestyle in a rural area in Bangladesh

  1. Immediately after the intervention (six months)

• Mobile use, reading SMS, intention to receive SMS for health information in people with high blood pressure in a rural area in Bangladesh

  1. Baseline

• Physical activity levels and intention to take part in physical activities in people with high blood pressure: A cluster RCT

  1. Baseline and 2. Immediately after the intervention (six months)

Study Arms (2)

Monitoring of lifestyle change activities

EXPERIMENTAL

The intervention arm will involve (i) the delivery of a blended learning education program and (ii) weekly phone calls to participants. The lectures will be delivered to 10 teams, comprised of about 15 participants in each team and lead by a volunteer team leader using the ORCD's laptop, overhead projector and the sound system in local clubs, school premises or participants' houses. The ORCD investigator including the physician and an information technology person will facilitate the education programs. The interpretations or additional explanations will be made by the physician following WHO guidelines and recommendations\[36\]. The investigator will maintain a folder for each team and will communicate at least with the team leaders by phone calls once every week to remind them to adhere to lifestyle modification intervention program. The weekly monitoring program will continue until the study ends.

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

lifestyle change activities: non-monitoring

NO INTERVENTION

The control group will only receive the printed materials, no active monitoring

Interventions

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

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.

Also known as: Monitoring of lifestyle change activities

Monitoring of lifestyle change activities

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with clinic blood pressure more than or equal to 130/80 mm Hg who are not taking medication
• Participants with controlled blood pressure defined as \< 130/80 using anti-hypertensive medication for a minimum of six weeks.
• Participants live in Banshgram Union only

You may not qualify if:

• Aged \> 75 years of age
• Pregnant women
• People who have advanced CVDs or are any serious condition that restricts their participation in the study
• Participants will be withdrawn from the study if they are unwilling to continue their participation and withdraw their consent, or any women participants who become pregnant during the study.

Sponsors & Collaborators

• Organisation for Rural Community Development, Bangladesh: lead
• Swinburne University of Technology: collaborator

Study Sites (1)

Organisation for Rural Community Development

Narail, 7500, Bangladesh

RECRUITING

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  PMID: 40354386 DERIVED

• Islam FMA, Lambert EA, Islam SMS, Islam MA, Biswas D, McDonald R, Maddison R, Thompson B, Lambert GW. Lowering blood pressure by changing lifestyle through a motivational education program: a cluster randomized controlled trial study protocol. Trials. 2021 Jul 8;22(1):438. doi: 10.1186/s13063-021-05379-2.

  PMID: 34238363 DERIVED

MeSH Terms

Conditions

Hypertension; Motor Activity; Smoking

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Fakir M Amirul Islam, PhD

  Organisation for Rural Community Development

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fakir M Amirul Islam, PhD

CONTACT

+61433968084; amirul.islam@orcdbd.org

Sadequl Islam, MBA

CONTACT

+8801912626902; sadequlislam60@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The individual participant will not be randomly assigned but as a group of participants (intervention arm and control arm) will be randomly selected.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomised

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 10, 2020
• Study Start: November 1, 2020
• Primary Completion: January 31, 2021
• Study Completion: December 31, 2022
• Last Updated: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After two years of data collection
• Access Criteria: Contact with the chief investigator: amirul.islam@orcdbd.org; fislam@swin.edu.au

Locations

BA (1)