Efficacy of Counselling for the Prevention of Hypertension Among Slum Dwellers in Dhaka City, Bangladesh
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 1,700
- Locations
- 1
- Primary Endpoint
- BMI classification (kg/m²)
Study Overview
Brief Summary
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:
- Is counseling a more effective intervention for the prevention of hypertension among adult slum dwellers in Dhaka city compared to other interventions?
Participants will:
- provide data related to tobacco use, physical activity, and dietary intake.
- provide a sample for blood pressure measurements. Will receive the WHO Brief Counselling intervention through 20 personalised sessions (each lasting approximately 20 minutes), focusing on lifestyle modifications, including physical activity promotion, balanced nutrition, and hypertension awareness.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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:
- •kidney disease
- •psychiatric illness
- •including depression
- •Pregnant women
Arms & Interventions
Control group (CG)
CG-1: Leaflet + Dummy counselling CG-2: Mobile SMS + Dummy counselling CG-3: Leaflet + Mobile SMS + Dummy counselling
Intervention: Leaflets and mhealth education (Behavioral)
Placebo
CG-4: No intervention + Dummy counselling.
Intervention: Dummy Placebo (Other)
Intervention group (IG)
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)
Intervention: counseling, leaflet and mhealth education for hypertension (Behavioral)
Outcomes
Primary Outcomes
BMI classification (kg/m²)
Time Frame: From enrollment until 18 months
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
Waist circumference (cm)
Time Frame: From enrollment until 18 months
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.
Waist-to-hip ratio
Time Frame: From enrollment until 18 months
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.
Tobacco use in the past 30 days
Time Frame: From enrollment until 18 months
Those who have the past 30 days history of smoking or use of smokeless tobacco will be considered as a current tobacco user.
Physical activity level (MET-minutes/week)
Time Frame: From enrollment until 18 months
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
Inadequate fruit and/or vegetables intake (servings)
Time Frame: From enrollment until 18 months
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.
Dietary salt intake
Time Frame: From enrollment until 18 months
The added salt consumption will be defined as taking dietary salt during eating a meal.
Secondary Outcomes
- Lipid profile (mg/dL)(From enrollment until 18 months)
- Systolic Blood pressure (mmHg)(From enrollment until 18 months)
- Diastolic blood pressure (mmHg)(From enrollment until 18 months)
- Heart rate (beats per minute)(From enrollment until 18 months)
- Fasting blood glucose (mg/dL)(From enrollment until 18 months)
- Diagnosis of Type 2 Diabetes Mellitus(From enrollment until 18 months)
- High-sensitivity C-reactive protein (hs-CRP) (mg/L)(From enrollment until 18 months)
- Urine creatinine test (mg/dL)(From enrollment until 18 months)
- Urinary sodium (Na+) and potassium (K+) estimation (mmol/L)(From enrollment until 18 months)
- 10-year cardiovascular disease (CVD) risk prediction(From enrollment until 18 months)
Investigators
Palash Chandra Banik
Associate Professor
Bangladesh University of Health Sciences