An interventional study of counseling, leaflet and mhealth education for hypertension and Leaflets and mhealth education in Hypertension and Cardiovascular Diseases, sponsored by Bangladesh University of Health Sciences. Enrolling by invitation at 1 site in Bangladesh. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by Bangladesh University of Health Sciences · Not applicable, Interventional, and Prevention
This study aims to evaluate the effectiveness of counseling interventions in promoting positive changes in hypertension markers among adult slum dwellers. The intervention is designed to address modifiable risk factors, such as physical inactivity, obesity, unhealthy dietary practices, tobacco and harmful uses of alcohol within a resource-limited community setting. The main question it aims to answer is:
Participants will:
This study aims to provide valuable insights into the effectiveness of counseling interventions in improving hypertension-related health outcomes among vulnerable urban populations. By focusing on modifiable risk factors, such as physical activity, dietary behavior, and tobacco use, the study will assess the potential of personalized counseling to reduce obesity, improve lipid profiles, and lower blood pressure. The intervention group will receive leaflet and counseling; and the control group will receive a leaflet only. After randomization, we will perform a baseline assessment. The participants will be allocated using stratified randomization. Allocation coverup will be ensured by performing allocation after completing all baseline assessments. A researcher who will not directly be involved with study delivery will allocate participants in a 1:1 ratio, generating a random sequence.
For both the primary and secondary outcomes, an intent-to-treat (ITT) design will be employed to ensure the robustness of the findings by including all participants, regardless of whether they complete the study or drop out. To address the potential impact of missing data due to dropout, participants will still be invited back for final assessment evaluations, minimizing bias in outcome measurement.
Through rigorous monitoring of primary and secondary outcomes in a double-blinded randomized controlled trial, the findings are expected to contribute to evidence-based public health interventions tailored for slum communities in Dhaka. These insights will guide future programs aimed at reducing the burden of hypertension and associated cardiovascular risks. The study will also highlight the importance of community-level preventive strategies in addressing chronic diseases where access to healthcare is limited. Ultimately, the research can inform scalable public health initiatives, advancing efforts toward equitable healthcare solutions in urban low-income settings
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's planned enrollment of 1,700 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
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Inclusion Criteria: People who are not diagnosed as hypertensive patients are healthy and have no history of diseases and stay in the slum for at least one year.
Exclusion Criteria: People who have the following condition will be excluded:
CG-1: Leaflet + Dummy counselling CG-2: Mobile SMS + Dummy counselling CG-3: Leaflet + Mobile SMS + Dummy counselling
Behavioral: Leaflets and mhealth education
CG-4: No intervention + Dummy counselling.
Other: Dummy Placebo
IG-1: Leaflet + Counselling (WHO Brief interventions) IG-2: Mobile SMS + Counselling (WHO Brief interventions) IG-3: Leaflet + Mobile SMS + Counselling (WHO Brief interventions) IG-4: Counselling (WHO Brief interventions)
Behavioral: counseling, leaflet and mhealth education for hypertension
Investigators will develop 6 leaflets and 24-SMSs containing messages on the burden of hypertension, consequences, and the benefits of preventing of hypertension, and the healthy practices for preventing hypertension, tobacco, physical inactivity, dietary salt intake, inadequate fruits and vegetables, overweight and obesity, and the use of trans fat. It will be written in plain and simple Bengali. Leaflets will be received by CG-1, CG-3, IG-1 and IG-3. 24-SMSs. Face-to-face counselling (approximately 20 min/session). A total of 20 sessions (1 cycle) will be provided. The session will be repeated if the cycle is over.
Participants will receive 6 leaflets containing messages on the burden of hypertension, consequences, and benefits of prevention of hypertension, and the healthy practices for preventing hypertension. Participants will receive 24 SMSs containing the burden of hypertension, consequences, and benefits of prevention of hypertension, and the healthy practices for preventing hypertension. And additionally receive a dummy counselling of 5 to 10 minutes informal discussion with the participants, which will not include any health messages that will be received by the participants of the intervention group.
Participants will only receive a dummy counselling of 5 to 10 minutes informal discussion with the participants, which will not include any health messages that will be received by the participants of the intervention group.
BMI classification (kg/m²)
Body mass index (BMI) will be calculated as weight in kilograms divided by height in meters squared (kg/m²). The participants will be considered as obese and over-weight when BMI ≥ 30kg/m2 and 25-29.9 kg/m2, respectively
Time frame: From enrollment until 18 months
Waist circumference (cm)
Central obesity was categorized according to the cut-off value specified by the international Diabetes Federation--- waist circumference 90 cm for men and 80 cm for women or waist-hip ratio\>0.90 for men and \>0.85 for women.
Time frame: From enrollment until 18 months
Waist-to-hip ratio
Waist-to-hip ratio will be calculated as the ratio of waist circumference to hip circumference. Central obesity will be defined as a ratio \>0.90 in men and \>0.85 in women.
Time frame: From enrollment until 18 months
Tobacco use in the past 30 days
Those who have the past 30 days history of smoking or use of smokeless tobacco will be considered as a current tobacco user.
Time frame: From enrollment until 18 months
Physical activity level (MET-minutes/week)
As per the WHO STEPS protocol, we were converted all work-related physical activities in metabolic equivalent of task in minutes per day (MET-minute) as follows: 1 minute in sedentary position = 1 MET-minute 1 minute in a moderate physical activity = 4 MET-minutes 1 minute in a vigorous physical activity = 8 MET-minutes All MET-minutes were then added together to get the cumulative MET-minutes. As per the cumulative MET-minutes, participants were categorized as less, moderately, and highly active: * 600 MET-minutes per week = less active * 600-3000 MET-minutes per week = moderately active ≥ 3000 MET-minutes per week = highly active The rest of the respondents, those didn't not meet even moderate activities, they were categorized as low activity
Time frame: From enrollment until 18 months
Inadequate fruit and/or vegetables intake (servings)
WHO recommendation of fruit and/or vegetable intake \<5 servings per day was considered as an inadequate intake. Participants will be asked about the number of days they used to eat fruit and vegetables in a week and the number of servings on those days they eat these. One standard serving size equal to 80 grams.
Time frame: From enrollment until 18 months
Dietary salt intake
The added salt consumption will be defined as taking dietary salt during eating a meal.
Time frame: From enrollment until 18 months
Systolic Blood pressure (mmHg)
The blood pressure of the respondents will be measured following WHO guideline for blood pressure measurement using WHO-certified automated blood pressure monitor namely OMRON model HEM-7121 made in Japan. Hypertension will be defined as SBP ≥140 mmHg or if the participant is on antihypertensive treatment.
Time frame: From enrollment until 18 months
Diastolic blood pressure (mmHg)
The participants will be considered hypertensive when the systolic blood pressure reading was ≥140 mmHg and/or the diastolic blood pressure reading was ≥ 90 mmHg or known case hypertensive or on antihypertensive medication. Raised blood pressure means SBP: ≥ 120 mmHg and /or DBP: ≥ 80 mmHg
Time frame: From enrollment until 18 months
Heart rate (beats per minute)
Heart rate refers to the number of times the heart beats per minute (bpm). In this study, heart rate will be measured using a validated automated device (OMRON model HEM-7121) following the standard protocols recommended by the World Health Organization. Participants will be instructed to rest for at least five minutes before the measurement to ensure accuracy. Heart rate readings will be taken at baseline and follow-up intervals to track any significant changes over time, with abnormal heart rates defined as below 60 bpm (bradycardia) or above 100 bpm (tachycardia) in accordance with clinical guidelines.
Time frame: From enrollment until 18 months
Lipid profile (mg/dL)
Serum total cholesterol, triglycerides and HDL-cholesterol will be measured by end-point method using Backman Coulter AU-480 automated Biochemistry analyzer. Serum LDL-cholesterol will be calculated using Friedewald formula. Dyslipidemia was defined as Total Cholesterol ≥ 200 mg/dl, or Triglycerides ≥150 mg/dl, or Low-density lipoprotein cholesterol (LDL-C) ≥ 130 mg/dl, or HDL-C \< 40 mg/dl (for men) and High-density lipoprotein cholesterol (HDL-C) \< 50 (for women)
Time frame: From enrollment until 18 months
Fasting blood glucose (mg/dL)
Fasting blood sugar levels will be measured from venous samples following an 8-hour fast using the Turbidimetric Immunoinhibition methods using Backman Coulter AU-480.
Time frame: From enrollment until 18 months
Diagnosis of Type 2 Diabetes Mellitus
Type 2 diabetes mellitus will be diagnosed if fasting blood glucose is ≥126 mg/dL or if the participant is on antidiabetic medication, following WHO criteria.
Time frame: From enrollment until 18 months
High-sensitivity C-reactive protein (hs-CRP) (mg/L)
Hs-CRP will be measured using turbidimetric immunoassay methods with a Beckman Coulter AU-480 automated biochemistry analyzer. Blood samples will be collected from participants after fasting, and Hs-CRP levels will be expressed in milligrams per liter (mg/L). Following clinical standards, values below 1 mg/L indicate low cardiovascular risk, 1-3 mg/L represent moderate risk, and above 3 mg/L indicate high cardiovascular risk
Time frame: From enrollment until 18 months
Urine creatinine test (mg/dL)
Following instruction on proper urine preservation, participants were given a 15-20 ml sterile labeled container to collect urine for urine specimens, which were to be stored overnight at room temperature before being collected the following morning. The creatinine level was estimated using the Jaffy method and the Backman Coulter AU-480 automated Biochemistry analyzer was used to measure serum creatinine.
Time frame: From enrollment until 18 months
Urinary sodium (Na+) and potassium (K+) estimation (mmol/L)
In this investigation, we employed the Tanaka equation to estimate 24-hour urine Na+, K+, and Na+/K+ ratio. The equation used Japanese data items from the INTERSALT project, which was carried out using a highly standardized technique, to build this equation to estimate 24-hour urine Na+ and K+ excretion. By contrasting 24-hour urine samples with spot urine from the same participants, they were able to create this equation. Additional data utilized to create the equation included the respondents' age, sex, height, weight, and creatinine levels. This was then used to get the 24-hour sodium intake, which was then divided by 17.1 as a conversion factor to determine the predicted salt intake in grams. Using the Backman Coulter AU-480 automated biochemistry analyzer, the ISE method will be used to measure the amount of sodium (Na+) in the urine.
Time frame: From enrollment until 18 months
10-year cardiovascular disease (CVD) risk prediction
CVD risk will be estimated using WHO/ISH risk prediction charts (version 2023), incorporating factors like age, sex, blood pressure, smoking status, diabetes, and total cholesterol. Risk will be categorized as very low risk \<5%, low risk 5%-\<10%, moderate risk 10%-\<20%, high risk 20%-\<30% and very high risk ≥30%
Time frame: From enrollment until 18 months
Plan to share: Yes — Only IPD used in the results publication.
Supporting information: Study protocol, Sap
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