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NCT Number: NCT03830021

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

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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Key information

Conditions

Blood Pressure Cardiovascular Diseases Hypertension Vascular Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital CUF Descobertas, Lisbon, Portugal

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Salt reduction program

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

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.

Primary outcomes

  1. Change in 24-hour urinary sodium excretion

    Time frame: 12 weeks

    Difference between the intervention and control group in the change in 24-hour urinary sodium excretion from baseline to the end of follow-up.

Secondary outcomes

  1. Change in systolic and diastolic blood pressure

    Time frame: 12 week

    Difference between the intervention and control group in the change in systolic and diastolic blood pressure from baseline to the end of follow-up.

  2. Change in weight

    Time frame: 12 week

    Difference between the intervention and control group in the change of weight from baseline to the end of follow-up.

  3. Change in waist circumference

    Time frame: 12 week

    Difference between the intervention and control group in the change of waist circumference from baseline to the end of follow-up.

  4. Change in salt content in foods purchased

    Time frame: 12 weeks

    Difference between the intervention and control group in the change of salt content in foods purchased from baseline to the end of follow-up.

Sponsors and collaborators

Lead sponsor

Academia Cuf Descobertas

Network

Collaborators

  • CUF Academic and Research Medical Center
  • José de Mello Saúde
  • NOVA Medical School
  • Pingo Doce

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2019
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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