A Community Health Worker-Led LSSS Intervention in Bangladesh

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Trial ID: NCT05425030

Purpose

The sodium found in salt is a powerful cause of high blood pressure, and most sodium ingested by humans is from their diet. High blood pressure is known to cause heart attacks and strokes, so various public health programs have attempted to find ways for people to reduce their salt intake to avoid these complications. These programs, however, have proven challenging, as asking people to alter their food preparation practices is often met with resistance. As such, we wish to test the blood pressure-lowering effects of low sodium salt substitute (LSSS), a salt substance in which a third of the compound by weight is composed of potassium (which does not increase blood pressure) rather than sodium. Additionally, the best way of supplying LSSS to people is yet unknown. We thus propose to study the effectiveness of an LSSS product by directly providing it via community health workers in 309 households in rural Bangladesh.

Official Title

Effectiveness of a Community Health Worker-Led Low-Sodium Salt Intervention to Reduce Blood Pressure: A Cluster Randomized Controlled Trial in Rural Bangladesh

Stanford Investigator(s)

Eligibility


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).

Intervention(s):

dietary supplement: Low-Sodium Salt Substitute

behavioral: Information/Education

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Animesh Talukder, MPH
+880 1670427812