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

Universidad Peruana Cayetano Heredia

Status: Completed

Conditions: Hypertension; Blood Pressure

Treatments: Other: Salt substitute

Study type: Interventional

Funder types: Other

Identifiers

NCT01960972

5U01HL114180

58563 (Other Identifier)

00004928 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,376 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,376 participants in 1 patient group

Salt substitute

Experimental group

Description:

As described by Brown, in a stepped wedge design, an intervention is rolled-out sequentially to the trial participants (either as individuals or clusters of individuals) over a number of time periods. The order in which the different individuals or clusters receive the intervention is determined at random and, by the end of the random allocation, all individuals or groups will have received the intervention. Stepped wedge designs incorporate data collection at each point where a new group (step) receives the intervention. Thus, the salt substitute will be implemented in each cluster (village) in a randomized fashion. Not arms are needed since the 6 randomly-selected villages will be implemented in some moment of the protocol.

Treatment:

Other: Salt substitute