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

NCT01960972 | Completed

• 3 other identifiers: 5U01HL1141805856300004928
• Study Type: interventional
• Target: 2,376
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Hypertension

Keywords

Blood pressure; Hypertension; Stepped wedge trial design

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Progression to hypertension

  Three years

Other Outcomes (1)

• Cost-effectiveness analysis

  Three years

Study Arms (1)

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.

Other: Salt substitute

Interventions

Salt substitute OTHER

A salt substitute using 25% of potassium chloride and 75% of sodium chloride will be implemented in each of the villages.

Salt substitute

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia: lead
• Johns Hopkins University: collaborator

Study Sites (1)

Center for Global Health (Universidad Peruana Cayetano Heredia)

Tumbes, Peru

Location

Related Publications (5)

• 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.

  PMID: 24667035 BACKGROUND

• 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.

  PMID: 28678190 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.

  PMID: 26225848 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.

  PMID: 32066973 RESULT

• 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.

  PMID: 37275501 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 11, 2013
• Study Start: March 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: August 26, 2021

Record last verified: 2021-08

Locations

PE (1)