Ignite Creation Date:
2024-05-06 @ 3:02 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04505150
Status:
UNKNOWN
Last Update Posted:
2021-09-23
First Post:
2020-08-06
Brief Title:
Lowering Blood Pressure by Changing Lifestyle
Sponsor:
Organisation for Rural Community Development Bangladesh
Organization:
Organisation for Rural Community Development Bangladesh
Study Overview
Official Title:
Lowering Blood Pressure by Changing Lifestyle Through a Motivational Education Program a Cluster RCT Study Protocol
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LBP
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
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 104 million deaths per year globally The prevalence of high blood pressure has increased from 870 million in 1999-2000 to 1082 million in 2015-2016 Of the 15 million worldwide annual deaths 94 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 14090 mm Hg The study reported a statistically significant mean reduction of systolic blood pressure of 52 mm Hg from the baseline mean blood pressure 1467 mm Hg compared to the usual care in which the reduction was 39 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
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 14090 mm Hg The study reported a statistically significant mean reduction of systolic blood pressure of 52 mm Hg from the baseline mean blood pressure 1467 mm Hg compared to the usual care in which the reduction was 39 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None