Launching a Salt Substitute to Reduce Blood Pressure at the Population Level in Peru

Not Applicable

Completed

• Conditions: Hypertension; Blood Pressure

• Registration Number: NCT01960972
• Lead Sponsor: Universidad Peruana Cayetano Heredia

Brief Summary

This protocol aims to implement, using a stepped wedge trial design, a population-level intervention to replace high-sodium salt for a salt substitute (low-sodium, high-potassium salt) to reduce blood pressure levels among adults aged 18 years and over of the semi-urban area of Tumbes.

We hypothesize that participants aged 18 years and over from villages receiving a salt substitute will have lower blood pressure compared to control villages.

Detailed Description

Several randomized clinical trials and meta-analysis have reported that reduction of sodium intake decreases blood pressure. Also, the increase of potassium ingestion in minimal doses has been found in systematic reviews to produce a small reduction in blood pressure levels.

The proposed intervention is a community-wide mass-strategy in which direct delivery of a salt substitute to households is accompanied by wide social marketing campaigns, both before and during the intervention period. With this experimental stepped wedge trial design, we will estimate the impact of a reduced-sodium salt substitution program on blood pressure at the population level.

We propose the following specific aims:

Specific Aim 1: To implement and assess the impact of an intervention using a salt substitute on blood pressure at the population level using a stepped wedge trial design.

Specific Aim 2: To determine costs and efficacy of this implementation strategy using cost-effectiveness analysis.

Study Timeline

• Study First Submitted: 2013-10-07
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-11
• Study Start: 2014-03
• Primary Completion: 2017-03
• Study Completion: 2017-04
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-22
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2376

Inclusion Criteria

• Males or females aged 18 years and over from the randomly selected villages.
• Capable of understanding study procedures and providing informed consent.
• Full-time resident in the area.

Exclusion Criteria

• Self-reported history of chronic kidney disease or heart disease.
• Refusal to participate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Systolic/diastolic blood pressure (mmHg)	Three years	We will assess changes in systolic and diastolic blood pressure over time. Periodic assessments will be carried out to obtain clinical measurements. Every five months, a new evaluation will be performed in all participant villages (intervention and control).; Systolic and diastolic blood pressure will be measured in triplicate using standard procedures and automated and validated devices. These periodic assessments will be taken at each household to guarantee contact with each family member enrolled in this study.

Secondary Outcome Measures

Name	Time	Method
Progression to hypertension	Three years	Using data of systolic and diastolic blood pressure, we will estimate progression towards hypertension among participants in intervened and control villages.

Trial Locations

Locations (1)

Center for Global Health (Universidad Peruana Cayetano Heredia); 🇵🇪 Tumbes, Peru