Clinical trial NCT07012096: Efficacy of Counselling for the Prevention of Hypertension (ECoPH)
Official title: Efficacy of Counselling for the Prevention of Hypertension Among Slum Dwellers in Dhaka City, Bangladesh
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Cardiovascular Diseases
Keywords: Hypertension
Cardiovascular diseases
counseling intervention
urban slums
randomized controlled trial
preventive healthcare
Dhaka
Good Clinical Practices
Lead sponsor: Bangladesh University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Bangladesh University of Professionals
First posted: 2025-06-10
Enrollment: 1700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: BMI classification (kg/m²)
timeFrame: From enrollment until 18 months
measure: Waist circumference (cm)
timeFrame: From enrollment until 18 months
measure: Waist-to-hip ratio
timeFrame: From enrollment until 18 months
measure: Tobacco use in the past 30 days
timeFrame: From enrollment until 18 months
measure: Physical activity level (MET-minutes/week)
timeFrame: From enrollment until 18 months
measure: Inadequate fruit and/or vegetables intake (servings)
timeFrame: From enrollment until 18 months
measure: Dietary salt intake
timeFrame: From enrollment until 18 months
Secondary outcomes:
measure: Systolic Blood pressure (mmHg)
timeFrame: From enrollment until 18 months
measure: Diastolic blood pressure (mmHg)
timeFrame: From enrollment until 18 months
measure: Heart rate (beats per minute)
timeFrame: From enrollment until 18 months
measure: Lipid profile (mg/dL)
timeFrame: From enrollment until 18 months
measure: Fasting blood glucose (mg/dL)
timeFrame: From enrollment until 18 months
measure: Diagnosis of Type 2 Diabetes Mellitus
timeFrame: From enrollment until 18 months
measure: High-sensitivity C-reactive protein (hs-CRP) (mg/L)
timeFrame: From enrollment until 18 months
measure: Urine creatinine test (mg/dL)
timeFrame: From enrollment until 18 months
measure: Urinary sodium (Na+) and potassium (K+) estimation (mmol/L)
timeFrame: From enrollment until 18 months
measure: 10-year cardiovascular disease (CVD) risk prediction
timeFrame: From enrollment until 18 months
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Kallyanpur Pora slum, Kalyanpur mahalla
Study officials:
affiliation: Bangladesh University of Health Sciences
name: Palash C. Banik, MPhil in Noncommunicable disea
role: PRINCIPAL_INVESTIGATOR
References: