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Effect of a Multi-component Education Program on Salt Reduction in Adults

A

Academia Cuf Descobertas

Status

Completed

Conditions

Hypertension
Blood Pressure

Treatments

Behavioral: Healthy lifestyle program
Behavioral: Salt reduction program

Study type

Interventional

Funder types

Other
NETWORK

Identifiers

NCT03830021
ReEducSal001

Details and patient eligibility

About

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.

Enrollment

311 patients

Sex

All

Ages

20 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

311 participants in 2 patient groups

Salt reduction program
Experimental group
Description:
Salt reduction program.
Treatment:
Behavioral: Salt reduction program
Healthy lifestyle program
Active Comparator group
Description:
Healthy lifestyle program.
Treatment:
Behavioral: Healthy lifestyle program

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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