Efficacy of Counselling for the Prevention of Hypertension (ECoPH)

NCT07012096 | Enrolling By Invitation DMC

• 1 other identifier: LS20221832
• Study Type: interventional
• Target: 1,700
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Cardiovascular Diseases

Keywords

Hypertension; Cardiovascular diseases; counseling intervention; urban slums; randomized controlled trial; preventive healthcare; Dhaka; Good Clinical Practices

Outcome Measures

Primary Outcomes (7)

• BMI classification (kg/m²)

  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

  From enrollment until 18 months

• Waist circumference (cm)

  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.

  From enrollment until 18 months

• Waist-to-hip ratio

  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.

  From enrollment until 18 months

• Tobacco use in the past 30 days

  Those who have the past 30 days history of smoking or use of smokeless tobacco will be considered as a current tobacco user.

  From enrollment until 18 months

• Physical activity level (MET-minutes/week)

  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

  From enrollment until 18 months

• Inadequate fruit and/or vegetables intake (servings)

  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.

  From enrollment until 18 months

• Dietary salt intake

  The added salt consumption will be defined as taking dietary salt during eating a meal.

  From enrollment until 18 months

Secondary Outcomes (10)

• 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

• Lipid profile (mg/dL)

  From enrollment until 18 months

• Fasting blood glucose (mg/dL)

  From enrollment until 18 months

Study Arms (3)

Control group (CG)

ACTIVE COMPARATOR

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

Behavioral: Leaflets and mhealth education

Placebo

PLACEBO COMPARATOR

CG-4: No intervention + Dummy counselling.

Other: Dummy Placebo

Intervention group (IG)

EXPERIMENTAL

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)

Behavioral: counseling, leaflet and mhealth education for hypertension

Interventions

counseling, leaflet and mhealth education for hypertension BEHAVIORAL

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.

Intervention group (IG)

Leaflets and mhealth education BEHAVIORAL

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.

Control group (CG)

Dummy Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Only individuals whose self-identified gender on their national identity card is listed as (Male/Female/other) are eligible to participate.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• kidney disease
• psychiatric illness
• including depression
• Pregnant women

Sponsors & Collaborators

• Bangladesh University of Health Sciences: lead
• Bangladesh University of Professionals: collaborator

Study Sites (1)

Kallyanpur Pora slum, Kalyanpur mahalla

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Interventions

Counseling

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Palash C. Banik, MPhil in Noncommunicable disea

  Bangladesh University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 10, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 1 year after publication with no end date
• Access Criteria: Data will be available upon valid request to the PI through email

Locations

BA (1)