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NCT05425030 | RECRUITING | Blood Pressure

A Community Health Worker-Led LSSS Intervention in Bangladesh
Sponsor:

Stanford University

Information provided by (Responsible Party):

Pascal money sheets

Brief Summary:

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.

Condition or disease

Blood Pressure

Hypertension

Intervention/treatment

Low-Sodium Salt Substitute

Information/Education

Phase

NA

Detailed Description:

The overall objective of this study is to assess the effectiveness of providing access to low-sodium salt substitute (LSSS) (a compound in which a percentage of the sodium chloride (NaCl) is replaced by potassium chloride (KCl) for blood pressure (BP) reduction in a general population of adults (aged 18 years and older) in rural Bangladesh. The intervention will be delivered in the study wing by community health workers to determine if this method is an efficacious approach for blood pressure lowering in this setting.

Study Type : INTERVENTIONAL
Estimated Enrollment : 1000 participants
Masking : DOUBLE
Masking Description : intervention), participants cannot be blinded. Investigators not involved in the allocation and direct data collection efforts, however, including the analysts, will be blinded to which household received which intervention. Of note, the community health workers responsible for provisioning the intervention and conducting the baseline survey will be a separate team of field workers from those collecting the endline outcomes assessment.
Primary Purpose : PREVENTION
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
Actual Study Start Date : 2023-01-26
Estimated Primary Completion Date : 2024-05-30
Estimated Study Completion Date : 2024-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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).
A Community Health Worker-Led LSSS Intervention in Bangladesh

Location Details

NCT05425030

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Locations

RECRUITING

Bangladesh, Mohakhali

BRAC University, James P Grant School of Public Health

Dhaka, Mohakhali, Bangladesh, 68 Tajuddin array