Efficacy of Counselling for the Prevention of Hypertension (ECoPH)

Bangladesh University of Health Sciences

Status: Invitation-only

Conditions: Hypertension; Cardiovascular Diseases

Treatments: Behavioral: counseling, leaflet and mhealth education for hypertension; Other: Dummy Placebo; Behavioral: Leaflets and mhealth education

Study type: Interventional

Funder types: Other

Identifiers

NCT07012096

LS20221832

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,700 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,700 participants in 3 patient groups, including a placebo group

Control group (CG)

Active Comparator group

Description:

CG-1: Leaflet + Dummy counselling CG-2: Mobile SMS + Dummy counselling CG-3: Leaflet + Mobile SMS + Dummy counselling

Treatment:

Behavioral: Leaflets and mhealth education

Placebo

Placebo Comparator group

Description:

CG-4: No intervention + Dummy counselling.

Treatment:

Other: Dummy Placebo

Intervention group (IG)

Experimental group

Description:

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)

Treatment:

Behavioral: counseling, leaflet and mhealth education for hypertension