NCT07012096

Efficacy of Counselling for the Prevention of Hypertension (ECoPH)

Efficacy of Counselling for the Prevention of Hypertension Among Slum Dwellers in Dhaka City, Bangladesh

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,700 (estimated)
• Sponsor: Bangladesh University of Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Conditions

• Hypertension
• Cardiovascular Diseases

Interventions

Type	Name	Description
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.
BEHAVIORAL	Leaflets and mhealth education	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.
OTHER	Dummy Placebo	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.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-12-30
• Completion: 2027-03-30
• First posted: 2025-06-10
• Last updated: 2026-02-04

Locations

1 site across 1 country: Bangladesh