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

January 9, 2020 updated by: Academia Cuf Descobertas

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

311

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lisbon, Portugal, 1350-070
        • Hospital CUF Infante Santo
      • Lisbon, Portugal, 1998-018
        • Hospital Cuf Descobertas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Salt reduction program
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.
Active Comparator: Healthy lifestyle program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 week
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.
12 week
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.
12 week
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jorge Polónia, PhD, CINTESIS, Faculty of Medicine of the University of Porto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2019

Primary Completion (Actual)

September 6, 2019

Study Completion (Actual)

September 6, 2019

Study Registration Dates

First Submitted

January 28, 2019

First Submitted That Met QC Criteria

February 4, 2019

First Posted (Actual)

February 5, 2019

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 9, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ReEducSal001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on Salt reduction program

3
Subscribe