Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 58563 | Other Identifier | UPCH SIDISI | |
| 00004928 | Other Identifier | JHU IRB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salt substitute | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salt substitute | Other | A salt substitute using 25% of potassium chloride and 75% of sodium chloride will be implemented in each of the villages. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systolic/diastolic blood pressure (mmHg) | 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. | Three years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression to hypertension | Using data of systolic and diastolic blood pressure, we will estimate progression towards hypertension among participants in intervened and control villages. | Three years |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness analysis | Three years |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jaime Miranda, MD, PhD | Universidad Peruana Cayetano Heredia | Principal Investigator |
| Robert H Gilman, MD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Antonio Bernabe-Ortiz, MD, MPH | Universidad Peruana Cayetano Heredia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Global Health (Universidad Peruana Cayetano Heredia) | Tumbes | Peru |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24667035 | Background | Bernabe-Ortiz A, Diez-Canseco F, Gilman RH, Cardenas MK, Sacksteder KA, Miranda JJ. Launching a salt substitute to reduce blood pressure at the population level: a cluster randomized stepped wedge trial in Peru. Trials. 2014 Mar 25;15:93. doi: 10.1186/1745-6215-15-93. | |
| 28678190 | Result | Pesantes MA, Diez-Canseco F, Bernabe-Ortiz A, Ponce-Lucero V, Miranda JJ. Taste, Salt Consumption, and Local Explanations around Hypertension in a Rural Population in Northern Peru. Nutrients. 2017 Jul 5;9(7):698. doi: 10.3390/nu9070698. |
Not provided
Not provided
Data can be shared potentially when main papers are published.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 26225848 | Result | Saavedra-Garcia L, Bernabe-Ortiz A, Gilman RH, Diez-Canseco F, Cardenas MK, Sacksteder KA, Miranda JJ. Applying the Triangle Taste Test to Assess Differences between Low Sodium Salts and Common Salt: Evidence from Peru. PLoS One. 2015 Jul 30;10(7):e0134700. doi: 10.1371/journal.pone.0134700. eCollection 2015. |
| 32066973 | Result | Bernabe-Ortiz A, Sal Y Rosas VG, Ponce-Lucero V, Cardenas MK, Carrillo-Larco RM, Diez-Canseco F, Pesantes MA, Sacksteder KA, Gilman RH, Miranda JJ. Effect of salt substitution on community-wide blood pressure and hypertension incidence. Nat Med. 2020 Mar;26(3):374-378. doi: 10.1038/s41591-020-0754-2. Epub 2020 Feb 17. |
| 37275501 | Derived | Lazo-Porras M, Del Valle A, Beran D, Pesantes MA, Perez-Leon S, Ponce-Lucero V, Bernabe-Ortiz A, Cardenas MK, Chappuis F, Perel P, Miranda JJ, Diez-Canseco F. Implementation of a salt substitute intervention using social marketing in resourced-limited communities in Peru: a process evaluation study. Front Public Health. 2023 May 19;11:1068624. doi: 10.3389/fpubh.2023.1068624. eCollection 2023. |