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

NCT03830021 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 311

Last updated 2020-01-13

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

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.

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.

Sponsors & Collaborators

  • Academia Cuf Descobertas

    lead NETWORK
  • CUF Academic and Research Medical Center

    collaborator UNKNOWN
  • José de Mello Saúde

    collaborator UNKNOWN
  • Pingo Doce

    collaborator UNKNOWN
  • NOVA Medical School

    collaborator OTHER

Principal Investigators

  • Jorge Polónia, PhD · CINTESIS, Faculty of Medicine of the University of Porto

  • Conceição Calhau, PhD · NOVA Medical School

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-28
Primary Completion
2019-09-06
Completion
2019-09-06

Countries

  • Portugal

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03830021 on ClinicalTrials.gov