- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lisbon, Portugal, 1350-070
- Hospital CUF Infante Santo
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Lisbon, Portugal, 1998-018
- Hospital Cuf Descobertas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Jorge Polónia, PhD, CINTESIS, Faculty of Medicine of the University of Porto
Publications and helpful links
General Publications
- Polonia J, Martins L, Pinto F, Nazare J. Prevalence, awareness, treatment and control of hypertension and salt intake in Portugal: changes over a decade. The PHYSA study. J Hypertens. 2014 Jun;32(6):1211-21. doi: 10.1097/HJH.0000000000000162.
- Polonia J, Monteiro J, Almeida J, Silva JA, Bertoquini S. High salt intake is associated with a higher risk of cardiovascular events: a 7.2-year evaluation of a cohort of hypertensive patients. Blood Press Monit. 2016 Oct;21(5):301-6. doi: 10.1097/MBP.0000000000000205.
- Polonia J, Lobo MF, Martins L, Pinto F, Nazare J. Estimation of populational 24-h urinary sodium and potassium excretion from spot urine samples: evaluation of four formulas in a large national representative population. J Hypertens. 2017 Mar;35(3):477-486. doi: 10.1097/HJH.0000000000001180.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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