Lowering Blood Pressure by Changing Lifestyle

Study Overview
=================
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.

Detailed Description
-----------------
High blood pressure is a fundamental cause of cardiovascular disease (CVD) and a major cause of disability and death. Raised blood pressure accounts for as many as 10.4 million deaths per year globally. The prevalence of high blood pressure has increased from 87.0 million in 1999-2000 to 108.2 million in 2015-2016. Of the 1.5 million worldwide annual deaths, 9.4% has been attributed to high blood pressure. Modifiable risk factors such as smoking, unhealthy diet and physical inactivity are shared and established risk factors for CVDs. Lifestyle changes such as smoking cessation, diet alteration including a reduction in dietary sodium intake and increased physical activity can improve health outcomes by decreasing or slowing complications associated with high blood pressure and other CVDs. Development and subsequent evaluation of effectiveness for any intervention targeting high blood pressure should include core components comprising baseline participant assessment, educational interventions for participants to acquire adequate knowledge about the etiology and risk factors of hypertension, and modification of lifestyle factors such as participating in regular physical activity, consuming a healthy diet and smoking cessation. Despite the high prevalence of high blood pressure in low-income and middle-income countries, there are relatively few data on intervention programs from low-income and middle-income countries (LMICs). Studies also report that a significant proportion of people with high blood pressure are undiagnosed or do not meet targets to control blood pressure both in developed and in LMICs. Among people with known high blood pressure, less than one-third of people are able to control their high blood pressure with appropriate treatment. Lifestyle modification programs have been shown to be effective in controlling blood pressure in LMICs. Bangladesh, a low-income country in South East Asia, is currently confronting an increasing burden of chronic diseases, including high blood pressure. Islam et al. conducted a cross-sectional study among adults age ≥30 years in a rural district in Bangladesh that reported the knowledge, attitudes and practice of diabetes and common eye diseases, and found overall knowledge was below average. The study also reported the prevalence and risk factors associated with known and undiagnosed diabetes, and self-reported known high blood pressure and newly diagnosed high blood pressure. The study identified that 40% of adults had high blood pressure, of which 82% were previously undiagnosed. Almost 60% of those with high blood pressure also had diabetes. Recently, a community-based cluster randomized controlled trial was conducted in rural communities in Bangladesh, Pakistan and Sri Lanka. This multicomponent intervention program was conducted for 24 months in 2645 adults with hypertension defined as blood pressure greater than or equal to 140/90 mm Hg. The study reported a statistically significant mean reduction of systolic blood pressure of 5.2 mm Hg from the baseline mean blood pressure 146.7 mm Hg compared to the usual care in which the reduction was 3.9 mm Hg. Relatively small reductions of 2 mm Hg in SBP and DBP have been reported to lower the risk of stroke by 14% and 17%, respectively, and the risk of coronary artery disease by 9% and 6%, respectively. The intervention program included home visits by government community health workers for blood-pressure monitoring and counselling and the training of physicians. A possible limitation of this intervention program maybe that home visits by trained community health workers for blood pressure monitoring and counselling may not be a sustainable and cost-saving approach due to the shortage of qualified workforce and the budget constraints in low- middle-income countries. Application of blended learning education programs to educate patients in managing blood pressure by changing lifestyle and participation in intervention programs as volunteers coordinated by volunteer leaders may be a sustainable approach for lowering blood pressure in the community setting. The goal of this pilot study is to compare a multicomponent intervention program to evaluate its effectiveness for lowering blood pressure among adults with high blood pressure in a rural district in Bangladesh. Health literacy is a complex and combined perception comprising a range of attributes including available resources of health-related information, and an individuals' intellectual, emotional, social and personal skills. Health literacy empowers people with skills to improve their health and well-being. Evidence indicates that deficits in health literacy are associated with poorer health outcomes and higher health-related costs at both individual and system levels. Improved health literacy had been reported to be associated with reductions in risk behaviours for chronic disease. However, an extended and often asymptomatic onset and a need for ongoing management, these conditions present people with a sharp and upward learning curve about risks, treatments and self-care. Self-care, especially in resource-limited settings, an essential dimension of treatment, depends on the ability of systems and providers to teach and patients to learn effective self-management skills. At the individual level, good health literacy is the foundation of successful management and prevention of chronic disease. Health literacy assessment can be used to improve community participation in health, health service planning, public health education, and policy development. In the past decade, much research on the impact of health literacy on health outcomes has been conducted across the globe; however, health literacy tools in rural areas of Bangladesh have not been developed or tested. The European Health Literacy Survey (HLS- Q12) questionnaire has been used to assess health literacy; however, its usefulness to measure health literacy in rural Bangladesh has not been investigated.

Official Title
-----------------
Lowering Blood Pressure by Changing Lifestyle Through a Motivational Education Program: a Cluster RCT Study Protocol

Conditions
-----------------
High Blood Pressure

Intervention / Treatment
-----------------
* Behavioral: Lifestyle changes, e.g., take part in regular exercise, quitting smoking, and reduce salt consumption


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomised
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monitoring of lifestyle change activities<br>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<br>* 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.<br>* Other names: Monitoring of lifestyle change activities;|
| No Intervention: lifestyle change activities: non-monitoring<br>The control group will only receive the printed materials, no active monitoring | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the psychometric properties of a Health literacy tool, European Health Literacy Survey Questionnaire (HLS-Q12) in rural Bangladesh. | Psychometric properties of a Health literacy tool will be investigated. HLQ12 is a 12 item questionnaire developed to measure health literacy related to knowledge of and access to health. The Questionnaire was developed and valided in European countries but it is not known whether all items are appropriate in any developing countries such as in Bangladesh. Therefore, using Rasch analysis, we could investigate if 12 items are necessary or need any modifications. Therefore, the outcome measure is the tool itself. Do we need all the items or not? | Baseline | 
| Assesment of the level of health literacy using health related scale European Health Literacy Survey Questionnaire | Estimate the current level of health literacy. After assessing psychometric properties, we may come up with all 12 or removing one or two items. Based on these items, we will be able to report the proportion of people who have a higher/lower level of health literacy. For example, 70 percent of people with higher education are able to access to health facilities, can read prescriptions or can take a decision which physicians they need to go compared to 30 per cent in people who are illiterate. Outcome: proportion. Each item of the scale has four categories (1-4), 1 is associated low level of literacy and 4 mean high level of literacy | 1. Baseline and 2. Immediately after the intervention (six months) | 
| Barriers and enablers in managing healthy lifestyle in a rural area in Bangladesh | Qualitative data will be collected from 10 participants and five health professionals and study coordinator. This is qualitative information from the participants to investigate the perceived barriers and enablers to scale up this study. The software NVivo will be used to investigate if there are any common themes of barriers which could intervene. This is descriptive information. | 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 | percentage of people who owns a mobile, can read SMS and willing to receive SMS and pay for it. Outcomes: Proportion | 1. Baseline | 
| Physical activity levels and intention to take part in physical activities in people with high blood pressure: A cluster RCT | Physical activity levels and their correlation with the socio-demographic factors (reported as proporion and relative risk), and intention to take part in physical activity program (reported as proporion and relative risk) in people with high blood pressure in a rural area in Bangladesh. Tool: Global Physical Activity Questionnaire (GPAQ). There are 17 items with yes and no responses. Yes indicates people take part in physical activity and no means they do not take part in physical activity. | 1. Baseline and 2. Immediately after the intervention (six months) | 
| Tobacco smoking and use of smokeless tobacco, and intention to quit among people with high blood pressure in a rural area in Bangladesh | Proportion of people who smoke tobacco and consume smokeless tobacco. What are the proportion of people who intend to quit smoking or reduce smoking within next three months or six months, and associated socio-demographic factors. Tool: Smoking cessation motivation questionnaire (Q-MAT). The Q-MAT has 19 items. Some items have yes and no responses and some items have 1-5 scores such as item 4: Do you think that smoking is bad for your health with possible responses are: 1.Not at all 2. A little 3. A lot 4. Enormously 5. I do not know. | 1. Baseline and 2. Immediately after the intervention (six months) | 
| Perception of and practice in salt and fruit consumptions and their associations with high blood pressure | Proportion of people who are aware that raw salt is not good for blood pressure, what are the factors associated, who are aware of healthy diet and how many people have been practicing. Tool: A modified version of Q-MAT | 1. Baseline and 3. Immediately after the intervention (six months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lifestyle, health literacy, cluster RCT, physical exercise, smoking