<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04505150</url>
  </required_header>
  <id_info>
    <org_study_id>LBP2723</org_study_id>
    <nct_id>NCT04505150</nct_id>
  </id_info>
  <brief_title>Lowering Blood Pressure by Changing Lifestyle</brief_title>
  <acronym>LBP</acronym>
  <official_title>Lowering Blood Pressure by Changing Lifestyle Through a Motivational Education Program: a Cluster RCT Study Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Organisation for Rural Community Development, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swinburne University of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Organisation for Rural Community Development, Bangladesh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: High blood pressure is an independent risk factor of cardiovascular disease&#xD;
      (CVD) and is a major cause of disability and death. Managing a healthy lifestyle has been&#xD;
      shown to reduce blood pressure and improve health outcomes. We aim to investigate the&#xD;
      effectiveness of a lifestyle modification intervention program for lowering blood pressure in&#xD;
      a rural area of Bangladesh.&#xD;
&#xD;
      Methods and analysis: A single-centre cluster randomized controlled trial (RCT). The study&#xD;
      will be conducted for six months, a total of 300 participants of age 30 to 75 years with 150&#xD;
      adults in each of the intervention and the control arms. The intervention arm will involve&#xD;
      the delivery of a blended learning education program on lifestyle changes for the management&#xD;
      of high blood pressure. The education program comprises evidence-based information with&#xD;
      pictures, fact sheets, and published literature about the effects of high blood pressure on&#xD;
      CVD development, increased physical activity and the role of a healthy diet in blood pressure&#xD;
      management. The control group involves providing information booklets and general advice at&#xD;
      the baseline data collection point. The primary outcome will be the absolute difference in&#xD;
      clinic systolic and diastolic blood pressure. Secondary outcomes include the difference in&#xD;
      the percentage of people adopting regular exercise habits, cessation of smoking and reducing&#xD;
      sodium chloride intake, health literacy of all participants, the perceived barriers and&#xD;
      enablers to adopt behaviour changes by collecting qualitative data. Analyses will include&#xD;
      analysis of covariance to report the mean difference in blood pressure between the control&#xD;
      and the intervention group and the difference in change in blood pressure due to the&#xD;
      intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      High blood pressure is a fundamental cause of cardiovascular disease (CVD) and a major cause&#xD;
      of disability and death. Raised blood pressure accounts for as many as 10.4 million deaths&#xD;
      per year globally. The prevalence of high blood pressure has increased from 87.0 million in&#xD;
      1999-2000 to 108.2 million in 2015-2016. Of the 1.5 million worldwide annual deaths, 9.4% has&#xD;
      been attributed to high blood pressure. Modifiable risk factors such as smoking, unhealthy&#xD;
      diet and physical inactivity are shared and established risk factors for CVDs. Lifestyle&#xD;
      changes such as smoking cessation, diet alteration including a reduction in dietary sodium&#xD;
      intake and increased physical activity can improve health outcomes by decreasing or slowing&#xD;
      complications associated with high blood pressure and other CVDs.&#xD;
&#xD;
      Development and subsequent evaluation of effectiveness for any intervention targeting high&#xD;
      blood pressure should include core components comprising baseline participant assessment,&#xD;
      educational interventions for participants to acquire adequate knowledge about the etiology&#xD;
      and risk factors of hypertension, and modification of lifestyle factors such as participating&#xD;
      in regular physical activity, consuming a healthy diet and smoking cessation. Despite the&#xD;
      high prevalence of high blood pressure in low-income and middle-income countries, there are&#xD;
      relatively few data on intervention programs from low-income and middle-income countries&#xD;
      (LMICs). Studies also report that a significant proportion of people with high blood pressure&#xD;
      are undiagnosed or do not meet targets to control blood pressure both in developed and in&#xD;
      LMICs. Among people with known high blood pressure, less than one-third of people are able to&#xD;
      control their high blood pressure with appropriate treatment. Lifestyle modification programs&#xD;
      have been shown to be effective in controlling blood pressure in LMICs.&#xD;
&#xD;
      Bangladesh, a low-income country in South East Asia, is currently confronting an increasing&#xD;
      burden of chronic diseases, including high blood pressure. Islam et al. conducted a&#xD;
      cross-sectional study among adults age ≥30 years in a rural district in Bangladesh that&#xD;
      reported the knowledge, attitudes and practice of diabetes and common eye diseases, and found&#xD;
      overall knowledge was below average. The study also reported the prevalence and risk factors&#xD;
      associated with known and undiagnosed diabetes, and self-reported known high blood pressure&#xD;
      and newly diagnosed high blood pressure. The study identified that 40% of adults had high&#xD;
      blood pressure, of which 82% were previously undiagnosed. Almost 60% of those with high blood&#xD;
      pressure also had diabetes.&#xD;
&#xD;
      Recently, a community-based cluster randomized controlled trial was conducted in rural&#xD;
      communities in Bangladesh, Pakistan and Sri Lanka. This multicomponent intervention program&#xD;
      was conducted for 24 months in 2645 adults with hypertension defined as blood pressure&#xD;
      greater than or equal to 140/90 mm Hg. The study reported a statistically significant mean&#xD;
      reduction of systolic blood pressure of 5.2 mm Hg from the baseline mean blood pressure 146.7&#xD;
      mm Hg compared to the usual care in which the reduction was 3.9 mm Hg. Relatively small&#xD;
      reductions of 2 mm Hg in SBP and DBP have been reported to lower the risk of stroke by 14%&#xD;
      and 17%, respectively, and the risk of coronary artery disease by 9% and 6%, respectively.&#xD;
      The intervention program included home visits by government community health workers for&#xD;
      blood-pressure monitoring and counselling and the training of physicians. A possible&#xD;
      limitation of this intervention program maybe that home visits by trained community health&#xD;
      workers for blood pressure monitoring and counselling may not be a sustainable and&#xD;
      cost-saving approach due to the shortage of qualified workforce and the budget constraints in&#xD;
      low- middle-income countries. Application of blended learning education programs to educate&#xD;
      patients in managing blood pressure by changing lifestyle and participation in intervention&#xD;
      programs as volunteers coordinated by volunteer leaders may be a sustainable approach for&#xD;
      lowering blood pressure in the community setting. The goal of this pilot study is to compare&#xD;
      a multicomponent intervention program to evaluate its effectiveness for lowering blood&#xD;
      pressure among adults with high blood pressure in a rural district in Bangladesh.&#xD;
&#xD;
      Health literacy is a complex and combined perception comprising a range of attributes&#xD;
      including available resources of health-related information, and an individuals'&#xD;
      intellectual, emotional, social and personal skills. Health literacy empowers people with&#xD;
      skills to improve their health and well-being. Evidence indicates that deficits in health&#xD;
      literacy are associated with poorer health outcomes and higher health-related costs at both&#xD;
      individual and system levels. Improved health literacy had been reported to be associated&#xD;
      with reductions in risk behaviours for chronic disease. However, an extended and often&#xD;
      asymptomatic onset and a need for ongoing management, these conditions present people with a&#xD;
      sharp and upward learning curve about risks, treatments and self-care. Self-care, especially&#xD;
      in resource-limited settings, an essential dimension of treatment, depends on the ability of&#xD;
      systems and providers to teach and patients to learn effective self-management skills. At the&#xD;
      individual level, good health literacy is the foundation of successful management and&#xD;
      prevention of chronic disease. Health literacy assessment can be used to improve community&#xD;
      participation in health, health service planning, public health education, and policy&#xD;
      development. In the past decade, much research on the impact of health literacy on health&#xD;
      outcomes has been conducted across the globe; however, health literacy tools in rural areas&#xD;
      of Bangladesh have not been developed or tested. The European Health Literacy Survey (HLS-&#xD;
      Q12) questionnaire has been used to assess health literacy; however, its usefulness to&#xD;
      measure health literacy in rural Bangladesh has not been investigated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">January 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Cluster randomised</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The individual participant will not be randomly assigned but as a group of participants (intervention arm and control arm) will be randomly selected.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in systolic and diastolic blood pressure in mmHg</measure>
    <time_frame>1. Baseline, 2. during the intervention (3 months) and 3. Immediately after the intervention (six months)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the psychometric properties of a Health literacy tool, European Health Literacy Survey Questionnaire (HLS-Q12) in rural Bangladesh.</measure>
    <time_frame>Baseline</time_frame>
    <description>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?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assesment of the level of health literacy using health related scale European Health Literacy Survey Questionnaire</measure>
    <time_frame>1. Baseline and 2. Immediately after the intervention (six months)</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barriers and enablers in managing healthy lifestyle in a rural area in Bangladesh</measure>
    <time_frame>1. Immediately after the intervention (six months)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobile use, reading SMS, intention to receive SMS for health information in people with high blood pressure in a rural area in Bangladesh</measure>
    <time_frame>1. Baseline</time_frame>
    <description>percentage of people who owns a mobile, can read SMS and willing to receive SMS and pay for it. Outcomes: Proportion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity levels and intention to take part in physical activities in people with high blood pressure: A cluster RCT</measure>
    <time_frame>1. Baseline and 2. Immediately after the intervention (six months)</time_frame>
    <description>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 &quot;yes&quot; and &quot;no&quot; responses. Yes indicates people take part in physical activity and &quot;no&quot; means they do not take part in physical activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tobacco smoking and use of smokeless tobacco, and intention to quit among people with high blood pressure in a rural area in Bangladesh</measure>
    <time_frame>1. Baseline and 2. Immediately after the intervention (six months)</time_frame>
    <description>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 &quot;yes&quot; and &quot;no&quot; 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of and practice in salt and fruit consumptions and their associations with high blood pressure</measure>
    <time_frame>1. Baseline and 3. Immediately after the intervention (six months)</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>High Blood Pressure</condition>
  <arm_group>
    <arm_group_label>Monitoring of lifestyle change activities</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>lifestyle change activities: non-monitoring</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will only receive the printed materials, no active monitoring</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle changes, e.g., take part in regular exercise, quitting smoking, and reduce salt consumption</intervention_name>
    <description>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.</description>
    <arm_group_label>Monitoring of lifestyle change activities</arm_group_label>
    <other_name>Monitoring of lifestyle change activities</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with clinic blood pressure more than or equal to 130/80 mm Hg who are not&#xD;
             taking medication&#xD;
&#xD;
          -  Participants with controlled blood pressure defined as &lt; 130/80 using&#xD;
             anti-hypertensive medication for a minimum of six weeks.&#xD;
&#xD;
          -  Participants live in Banshgram Union only&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aged &gt; 75 years of age&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  People who have advanced CVDs or are any serious condition that restricts their&#xD;
             participation in the study&#xD;
&#xD;
          -  Participants will be withdrawn from the study if they are unwilling to continue their&#xD;
             participation and withdraw their consent, or any women participants who become&#xD;
             pregnant during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fakir M Amirul Islam, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Organisation for Rural Community Development</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fakir M Amirul Islam, PhD</last_name>
    <phone>+61433968084</phone>
    <email>amirul.islam@orcdbd.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sadequl Islam, MBA</last_name>
    <phone>+8801912626902</phone>
    <email>sadequlislam60@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Organisation for Rural Community Development</name>
      <address>
        <city>Narail</city>
        <zip>7500</zip>
        <country>Bangladesh</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fakir M A Islam, PhD</last_name>
      <phone>01912626902</phone>
      <email>amirul.islam@orcdbd.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
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  </reference>
  <reference>
    <citation>Islam FM, Chakrabarti R, Islam SZ, Finger RP, Critchley C. Factors Associated with Awareness, Attitudes and Practices Regarding Common Eye Diseases in the General Population in a Rural District in Bangladesh: The Bangladesh Population-based Diabetes and Eye Study (BPDES). PLoS One. 2015 Jul 22;10(7):e0133043. doi: 10.1371/journal.pone.0133043. eCollection 2015.</citation>
    <PMID>26200458</PMID>
  </reference>
  <reference>
    <citation>Islam FM, Chakrabarti R, Islam MT, Wahab M, Lamoureux E, Finger RP, Shaw JE. Prediabetes, diagnosed and undiagnosed diabetes, their risk factors and association with knowledge of diabetes in rural Bangladesh: The Bangladesh Population-based Diabetes and Eye Study. J Diabetes. 2016 Mar;8(2):260-8. doi: 10.1111/1753-0407.12294. Epub 2015 May 6.</citation>
    <PMID>25851830</PMID>
  </reference>
  <reference>
    <citation>Finbraten HS, Wilde-Larsson B, Nordstrom G, Pettersen KS, Trollvik A, Guttersrud O. Establishing the HLS-Q12 short version of the European Health Literacy Survey Questionnaire: latent trait analyses applying Rasch modelling and confirmatory factor analysis. BMC Health Serv Res. 2018 Jun 28;18(1):506. doi: 10.1186/s12913-018-3275-7.</citation>
    <PMID>29954382</PMID>
  </reference>
  <reference>
    <citation>Dansou A, Groussin L, Gaborit C, Touraine A, Blanchet E, Laporte L, Jouneau C, Pennamen E, Maino B. [Approach and management of tobacco quitting process of the smoker patient by 149 residents in a university hospital in Tours]. Rev Mal Respir. 2012 Sep;29(7):878-88. doi: 10.1016/j.rmr.2012.02.010. Epub 2012 Jun 6. French.</citation>
    <PMID>22980548</PMID>
  </reference>
  <reference>
    <citation>Mumu SJ, Ali L, Barnett A, Merom D. Validity of the global physical activity questionnaire (GPAQ) in Bangladesh. BMC Public Health. 2017 Aug 10;17(1):650. doi: 10.1186/s12889-017-4666-0.</citation>
    <PMID>28797237</PMID>
  </reference>
  <reference>
    <citation>Chu AH, Ng SH, Koh D, Muller-Riemenschneider F. Reliability and Validity of the Self- and Interviewer-Administered Versions of the Global Physical Activity Questionnaire (GPAQ). PLoS One. 2015 Sep 1;10(9):e0136944. doi: 10.1371/journal.pone.0136944. eCollection 2015.</citation>
    <PMID>26327457</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>September 17, 2021</last_update_submitted>
  <last_update_submitted_qc>September 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lifestyle</keyword>
  <keyword>health literacy</keyword>
  <keyword>cluster RCT</keyword>
  <keyword>physical exercise</keyword>
  <keyword>smoking</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified data will be shared with other researchers for collaborations</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>After two years of data collection</ipd_time_frame>
    <ipd_access_criteria>Contact with the chief investigator: amirul.islam@orcdbd.org; fislam@swin.edu.au</ipd_access_criteria>
    <ipd_url>http://www.orcdbd.org</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04505150
org study id: LBP2723
nct id: NCT04505150
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Cluster randomised
primary purpose: Health Services Research
masking: None (Open Label)
masking description: The individual participant will not be randomly assigned but as a group of participants (intervention arm and control arm) will be randomly selected.
measure: Change in systolic and diastolic blood pressure in mmHg
time frame: 1. Baseline, 2. during the intervention (3 months) and 3. Immediately after the intervention (six months)
description: 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.
measure: Evaluation of the psychometric properties of a Health literacy tool, European Health Literacy Survey Questionnaire (HLS-Q12) in rural Bangladesh.
time frame: Baseline
description: 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?
measure: Assesment of the level of health literacy using health related scale European Health Literacy Survey Questionnaire
time frame: 1. Baseline and 2. Immediately after the intervention (six months)
description: 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
measure: Barriers and enablers in managing healthy lifestyle in a rural area in Bangladesh
time frame: 1. Immediately after the intervention (six months)
description: 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.
measure: Mobile use, reading SMS, intention to receive SMS for health information in people with high blood pressure in a rural area in Bangladesh
time frame: 1. Baseline
description: percentage of people who owns a mobile, can read SMS and willing to receive SMS and pay for it. Outcomes: Proportion
measure: Physical activity levels and intention to take part in physical activities in people with high blood pressure: A cluster RCT
time frame: 1. Baseline and 2. Immediately after the intervention (six months)
description: 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.
measure: Tobacco smoking and use of smokeless tobacco, and intention to quit among people with high blood pressure in a rural area in Bangladesh
time frame: 1. Baseline and 2. Immediately after the intervention (six months)
description: 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.
measure: Perception of and practice in salt and fruit consumptions and their associations with high blood pressure
time frame: 1. Baseline and 3. Immediately after the intervention (six months)
description: 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
arm group label: Monitoring of lifestyle change activities
arm group type: Experimental
description: 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.
arm group label: lifestyle change activities: non-monitoring
arm group type: No Intervention
description: The control group will only receive the printed materials, no active monitoring
intervention type: Behavioral
intervention name: Lifestyle changes, e.g., take part in regular exercise, quitting smoking, and reduce salt consumption
description: 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.
arm group label: Monitoring of lifestyle change activities
other name: Monitoring of lifestyle change activities
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fakir M Amirul Islam, PhD
role: Principal Investigator
affiliation: Organisation for Rural Community Development
last name: Fakir M Amirul Islam, PhD
phone: +61433968084
email: amirul.islam@orcdbd.org
last name: Sadequl Islam, MBA
phone: +8801912626902
email: sadequlislam60@gmail.com
facility: 
status: Recruiting
contact: 
country: Bangladesh
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citation: Islam FM, Chakrabarti R, Dirani M, Islam MT, Ormsby G, Wahab M, Critchley C, Finger RP. Knowledge, attitudes and practice of diabetes in rural Bangladesh: the Bangladesh Population based Diabetes and Eye Study (BPDES). PLoS One. 2014 Oct 14;9(10):e110368. doi: 10.1371/journal.pone.0110368. eCollection 2014.
PMID: 25313643
citation: Islam FM, Chakrabarti R, Islam SZ, Finger RP, Critchley C. Factors Associated with Awareness, Attitudes and Practices Regarding Common Eye Diseases in the General Population in a Rural District in Bangladesh: The Bangladesh Population-based Diabetes and Eye Study (BPDES). PLoS One. 2015 Jul 22;10(7):e0133043. doi: 10.1371/journal.pone.0133043. eCollection 2015.
PMID: 26200458
citation: Islam FM, Chakrabarti R, Islam MT, Wahab M, Lamoureux E, Finger RP, Shaw JE. Prediabetes, diagnosed and undiagnosed diabetes, their risk factors and association with knowledge of diabetes in rural Bangladesh: The Bangladesh Population-based Diabetes and Eye Study. J Diabetes. 2016 Mar;8(2):260-8. doi: 10.1111/1753-0407.12294. Epub 2015 May 6.
PMID: 25851830
citation: Finbraten HS, Wilde-Larsson B, Nordstrom G, Pettersen KS, Trollvik A, Guttersrud O. Establishing the HLS-Q12 short version of the European Health Literacy Survey Questionnaire: latent trait analyses applying Rasch modelling and confirmatory factor analysis. BMC Health Serv Res. 2018 Jun 28;18(1):506. doi: 10.1186/s12913-018-3275-7.
PMID: 29954382
citation: Dansou A, Groussin L, Gaborit C, Touraine A, Blanchet E, Laporte L, Jouneau C, Pennamen E, Maino B. [Approach and management of tobacco quitting process of the smoker patient by 149 residents in a university hospital in Tours]. Rev Mal Respir. 2012 Sep;29(7):878-88. doi: 10.1016/j.rmr.2012.02.010. Epub 2012 Jun 6. French.
PMID: 22980548
citation: Mumu SJ, Ali L, Barnett A, Merom D. Validity of the global physical activity questionnaire (GPAQ) in Bangladesh. BMC Public Health. 2017 Aug 10;17(1):650. doi: 10.1186/s12889-017-4666-0.
PMID: 28797237
citation: Chu AH, Ng SH, Koh D, Muller-Riemenschneider F. Reliability and Validity of the Self- and Interviewer-Administered Versions of the Global Physical Activity Questionnaire (GPAQ). PLoS One. 2015 Sep 1;10(9):e0136944. doi: 10.1371/journal.pone.0136944. eCollection 2015.
PMID: 26327457
responsible party type: Sponsor
mesh term: Hypertension
sharing ipd: Yes
ipd description: De-identified data will be shared with other researchers for collaborations
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: After two years of data collection
ipd access criteria: Contact with the chief investigator: amirul.islam@orcdbd.org; fislam@swin.edu.au
ipd url: http://www.orcdbd.org