Clinical trial NCT03830021: Effect of a Multi-component Education Program on Salt Reduction in Adults
Official title: Effect of a Multi-component Education Program on Salt Reduction in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Hypertension
Lead sponsor: Academia Cuf Descobertas
Sponsor class: NETWORK
Collaborators: name: CUF Academic and Research Medical Center
name: José de Mello Saúde
name: Pingo Doce
name: NOVA Medical School
First posted: 2019-02-05
Enrollment: 311
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Excess salt intake is a major contributor to high blood pressure, the leading individual risk factor for cardiovascular events, such as stroke, myocardial infarction and heart failure. According to PHYSA study, salt intake in Portugal remains much higher (10.7 g) than recommended by the international health organisations, indicating the need for effective implementation of salt reduction interventions. In Portugal the main source of daily salt intake is added salt during cooking, and salt content in bread, cheese and processed meat.

The objective of this study is to determine the effectiveness of a dietary education program tailored for salt reduction. To assess the effectiveness of the salt reduction program the investigator's will measure changes in salt consumption levels, by evaluating the 24 h urinary sodium excretion.

This study is a consortium-initiated, randomised, simple-blinded, controlled trial designed to assess the effectiveness of a salt reduction program versus generic healthy lifestyle program in the Lisbon Metropolitan Area.


Eligibility criteria: Inclusion Criteria:

* Adults between the ages of 20 and 70.
* Subjects with or without hypertension, not medicated or medicated with medication and diet stabilized for at least 3 weeks.
* Responsible for the purchase and confection of their meals.
* Available to comply with study protocol and sign informed consent.

Exclusion Criteria:

* Pregnant, breastfeeding or planning to become pregnant within the study period.
* Subjects with current or previous cardiovascular disease (ischemic cardiovascular disease, angina stable or unstable; myocardial infarction, stroke or symptomatic peripheral arteriosclerosis).
* Subjects with liver or kidney diseases or cancer.
* Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to cooperate during the study.
* Subjects with special dietary needs.
* Health condition that prevents compliance with study requirements.

Primary outcomes:
measure: Change in 24-hour urinary sodium excretion
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in systolic and diastolic blood pressure
timeFrame: 12 week
measure: Change in weight
timeFrame: 12 week
measure: Change in waist circumference
timeFrame: 12 week
measure: Change in salt content in foods purchased
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Hospital CUF Infante Santo
city: Lisbon
country: Portugal
facility: Hospital CUF Descobertas
Study officials:
affiliation: CINTESIS, Faculty of Medicine of the University of Porto
name: Jorge Polónia, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NOVA Medical School
name: Conceição Calhau, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Polonia J, Martins L, Pinto F, Nazare J. Prevalence, awareness, treatment and control of hypertension and salt intake in Portugal: changes over a decade. The PHYSA study. J Hypertens. 2014 Jun;32(6):1211-21. doi: 10.1097/HJH.0000000000000162.
citation: Polonia J, Monteiro J, Almeida J, Silva JA, Bertoquini S. High salt intake is associated with a higher risk of cardiovascular events: a 7.2-year evaluation of a cohort of hypertensive patients. Blood Press Monit. 2016 Oct;21(5):301-6. doi: 10.1097/MBP.0000000000000205.
citation: Polonia J, Lobo MF, Martins L, Pinto F, Nazare J. Estimation of populational 24-h urinary sodium and potassium excretion from spot urine samples: evaluation of four formulas in a large national representative population. J Hypertens. 2017 Mar;35(3):477-486. doi: 10.1097/HJH.0000000000001180.