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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

311 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-28

Study Completion Date

2019-09-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Blood Pressure Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Salt reduction program

Salt reduction program.

Group Type EXPERIMENTAL

Salt reduction program

Intervention Type BEHAVIORAL

Dietary and behavioural change program, led by nutritionists, including low sodium dietary advice; use of aromatic herbs and spices in food instead of salt; motivational activities; food diaries; restrict salty processed foods; eat more fresh foods and seasoning advice; problem solving exercises; digital bulletins; individual counselling reinforced at each clinic visit and shopping counselling at local supermarket.

Healthy lifestyle program

Healthy lifestyle program.

Group Type ACTIVE_COMPARATOR

Healthy lifestyle program

Intervention Type BEHAVIORAL

Participants receive an educational healthy lifestyle program that includes 1) methods to cook healthier and the Mediterranean diet based on a high intake of fresh fruit and, vegetables, beans, grain legumes, lentils, nuts, cereals, and olive oil as source of fat; moderate intake of fish, poultry, yoghurt and cheese, low intake of salt, red meat, processed meats and sugar; 2) physical activity; 3) drink more water and reducing alcohol consumption; and 4) sleep education.

Interventions

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Salt reduction program

Dietary and behavioural change program, led by nutritionists, including low sodium dietary advice; use of aromatic herbs and spices in food instead of salt; motivational activities; food diaries; restrict salty processed foods; eat more fresh foods and seasoning advice; problem solving exercises; digital bulletins; individual counselling reinforced at each clinic visit and shopping counselling at local supermarket.

Intervention Type BEHAVIORAL

Healthy lifestyle program

Participants receive an educational healthy lifestyle program that includes 1) methods to cook healthier and the Mediterranean diet based on a high intake of fresh fruit and, vegetables, beans, grain legumes, lentils, nuts, cereals, and olive oil as source of fat; moderate intake of fish, poultry, yoghurt and cheese, low intake of salt, red meat, processed meats and sugar; 2) physical activity; 3) drink more water and reducing alcohol consumption; and 4) sleep education.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes