Efficacy of Counselling for the Prevention of Hypertension (ECoPH)
NCT ID: NCT07012096
Last Updated: 2025-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1700 participants
INTERVENTIONAL
2025-06-20
2027-03-30
Brief Summary
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* 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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Control group (CG)
CG-1: Leaflet + Dummy counselling CG-2: Mobile SMS + Dummy counselling CG-3: Leaflet + Mobile SMS + Dummy counselling
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.
Placebo
CG-4: No intervention + Dummy counselling.
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.
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)
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Exclusion Criteria
* psychiatric illness
* including depression
* Pregnant women
18 Years
70 Years
ALL
Yes
Sponsors
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Bangladesh University of Professionals
UNKNOWN
Bangladesh University of Health Sciences
OTHER
Responsible Party
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Palash Chandra Banik
Associate Professor
Principal Investigators
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Palash C. Banik, MPhil in Noncommunicable disea
Role: PRINCIPAL_INVESTIGATOR
Bangladesh University of Health Sciences
Locations
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Kallyanpur Pora slum, Kalyanpur mahalla
Dhaka, , Bangladesh
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LS20221832
Identifier Type: -
Identifier Source: org_study_id
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