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

Overview

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

Interventions

• 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 (approxim
• 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, whic
• 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.

Primary outcome measures

• BMI classification (kg/m²) [Time frame: From enrollment until 18 months]
• Waist circumference (cm) [Time frame: From enrollment until 18 months]
• Waist-to-hip ratio [Time frame: From enrollment until 18 months]
• Tobacco use in the past 30 days [Time frame: From enrollment until 18 months]
• Physical activity level (MET-minutes/week) [Time frame: From enrollment until 18 months]
• Inadequate fruit and/or vegetables intake (servings) [Time frame: From enrollment until 18 months]
• Dietary salt intake [Time frame: From enrollment until 18 months]

Secondary outcome measures (10)

• Systolic Blood pressure (mmHg) [Time frame: From enrollment until 18 months]
• Diastolic blood pressure (mmHg) [Time frame: From enrollment until 18 months]
• Heart rate (beats per minute) [Time frame: From enrollment until 18 months]
• Lipid profile (mg/dL) [Time frame: From enrollment until 18 months]
• Fasting blood glucose (mg/dL) [Time frame: From enrollment until 18 months]
• Diagnosis of Type 2 Diabetes Mellitus [Time frame: From enrollment until 18 months]
• High-sensitivity C-reactive protein (hs-CRP) (mg/L) [Time frame: From enrollment until 18 months]
• Urine creatinine test (mg/dL) [Time frame: From enrollment until 18 months]
• Urinary sodium (Na+) and potassium (K+) estimation (mmol/L) [Time frame: From enrollment until 18 months]
• 10-year cardiovascular disease (CVD) risk prediction [Time frame: From enrollment until 18 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

Bangladesh · 1 center

• Kallyanpur Pora slum, Kalyanpur mahalla — Dhaka

Identifiers

NCT: NCT07012096 · LS20221832

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗