A Community Health Worker-Led LSSS Intervention in Bangladesh

Not Applicable

Recruiting

• Conditions: Hypertension; Blood Pressure
• Interventions: Dietary Supplement: Low-Sodium Salt Substitute; Behavioral: Information/Education

• Registration Number: NCT05425030
• Lead Sponsor: Stanford University

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-15
• Study First Posted: 2022-06-21
• Study Start: 2023-01-26
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-21
• Primary Completion: 2024-05-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Free LSSS Arm	Information/Education	Participants will receive 6 months of free low-sodium salt by delivery from a community health worker. In addition, the same educational information as provided in Arm 2 (Information Only Arm, below) will be provided.
Free LSSS Arm	Low-Sodium Salt Substitute	Participants will receive 6 months of free low-sodium salt by delivery from a community health worker. In addition, the same educational information as provided in Arm 2 (Information Only Arm, below) will be provided.
Information Only Arm	Information/Education	Community health workers will provide basic information on high blood pressure, the health consequences of excessive salt consumption, and feedback to the participant on the likely quantity of salt s/he consumes (estimated using a questionnaire)

Primary Outcome Measures

Name	Time	Method
Change in Systolic Blood Pressure at 6 months	6 months	Systolic blood pressure will be treated as a continuous variable expressed in millimeters of mercury (mmHg). This measurement will be made by trained fieldworkers using Omron Series 3 automatic portable blood pressure cuffs (Omron Healthcare, Kyoto, Japan) while trial subjects are in the seated position in the left arm after 15 minutes rest. Three measurements will be taken at least 5 minutes apart to ensure accurate capture, with the mean of the second and third measurements used in the final data analysis. These measurements will be taken at both baseline (prior to the initiation of the intervention) and at the endline survey at the conclusion of the study.
Change in Diastolic Blood Pressure at 6 months	6 months	Diastolic blood pressure will be treated as a continuous variable expressed in millimeters of mercury (mmHg). This measurement will be made by trained fieldworkers using Omron Series 3 automatic portable blood pressure cuffs (Omron Healthcare, Kyoto, Japan) while trial subjects are in the seated position in the left arm after 15 minutes rest. Three measurements will be taken at least 5 minutes apart to ensure accurate capture, with the mean of the second and third measurements used in the final data analysis. These measurements will be taken at both baseline (prior to the initiation of the intervention) and at the endline survey at the conclusion of the study.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Hypertension	6 months	Clinical hypertension will be defined as a measured blood pressure over 140mmHg systolic or over 90mmHg diastolic (or a pre-existing diagnosis of hypertension by patient report). This outcome will be treated as a binary variable.
Number of Participants AchievingHypertension Control	6 months	Hypertension control will be defined as an endline survey blood pressure below 140mmHg systolic or below 90mmHg diastolic in patients previously diagnosed with hypertension or meeting our trial definition of hypertension based on the baseline survey.

Trial Locations

Locations (1)

BRAC University, James P Grant School of Public Health; 🇧🇩 Dhaka, Mohakhali, Bangladesh