Launching a Salt Substitute to Reduce Blood Pressure at the Population Level in Peru
This trial is active, not recruiting.
|Conditions||blood pressure, hypertension|
|Sponsor||Universidad Peruana Cayetano Heredia|
|Collaborator||Johns Hopkins University|
|Start date||April 2014|
|End date||March 2017|
|Trial size||2000 participants|
|Trial identifier||NCT01960972, 00004928, 58563, 5U01HL114180|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Systolic/diastolic blood pressure (mmHg)
time frame: Three years
Progression to hypertension
time frame: Three years
Male or female participants at least 18 years old.
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.
|Official title||Launching a Salt Substitute to Reduce Blood Pressure at the Population Level - Peru|
|Principal investigator||Jaime Miranda, MD, PhD|
|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.|
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