Community health workers provide low-sodium salt substitutes in rural Bangladesh
Effectiveness of a Community Health Worker-Led Low-Sodium Salt Intervention to Reduce Blood Pressure: A Cluster Randomized Controlled Trial in Rural Bangladesh
This study is testing whether giving low-sodium salt substitutes to families in rural Bangladesh can help lower their blood pressure and improve heart health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Dhaka, Mohakhali) |
| Trial ID | NCT05425030 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a low-sodium salt substitute (LSSS) in reducing blood pressure among adults in rural Bangladesh. Community health workers will deliver the LSSS directly to households, addressing dietary sodium intake, which is a major contributor to hypertension. The study will involve 309 households and assess the impact of this intervention on blood pressure levels. By providing education and resources, the study seeks to overcome resistance to dietary changes and improve cardiovascular health in the community.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years and older living in rural Bangladesh, specifically in the Parbatipur area.
Not a fit: Patients who are taking potassium-sparing diuretics, potassium supplements, or have known kidney disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly lower blood pressure levels and reduce the risk of heart attacks and strokes in the target population.
How similar studies have performed: Other studies have shown promise in using dietary interventions to manage hypertension, but this specific approach using community health workers and LSSS is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Our target population is that of adults living in rural Bangladesh, while our study population will be comprised of adults (age ≥18 years old) living in Parbatipur, a rural/semi-rural sub-district in Dinajpur District (Rangpur Division), in the north of the country. Within Parbatipur, BRAC University has assessed 700 households for NCD risk factors as part of a larger Wellcome-trust funded multinational biobank (involving those living in Bangladesh, India, Pakistan, and Sri Lanka) to better understand the patterns and determinants of cardiovascular health in South Asian people in a cross-sectional analysis. All adults living in these surveyed households will be eligible to participate. Exclusion Criteria: * Exclusion criteria include subjects taking potassium-sparing diuretics, already taking potassium supplements, or those who have known kidney disease at baseline. * All adults initially screened for intervention will undergo serum creatinine testing, with those with values \>106 mMol/L for males and \>97 mMol/L for female excluded from the intervention but kept in the intervention group by intention-to-treat principles to avoid breaking of randomization. * Although minors will not be involved in the study, to avoid spillover injury to children in the intervention households, all members of intervention households under the age of 18 will also undergo urine dipstick testing. If proteinuria is detected, the household will be excluded from receiving the LSSS intervention (but followed in the intervention arm to avoid breaking randomization).
Where this trial is running
Dhaka, Mohakhali
- BRAC University, James P Grant School of Public Health — Dhaka, Mohakhali, Bangladesh (Recruiting)
Study contacts
- Principal investigator: Malabika Sarker, PhD — James P Grant School of Public Health, BRAC University
- Study coordinator: Animesh Talukder, MPH
- Email: animesh.talukder@bracu.ac.bd
- Phone: +880 1670427812
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.