Blood Pressure, Hypertension
Conditions
Keywords
Blood pressure, Hypertension, Stepped wedge trial design
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.
Interventions
OTHERSalt substitute
A salt substitute using 25% of potassium chloride and 75% of sodium chloride will be implemented in each of the villages.
Sponsors
Johns Hopkins University
Universidad Peruana Cayetano Heredia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame |
|---|---|
| Cost-effectiveness analysis | Three years |
Countries
Peru
Outcome results
None listed