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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Blood Pressure, Hypertension

Intervention / Treatment
-----------------
* Behavioral: Salt reduction program
* Behavioral: Healthy lifestyle program


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salt reduction program<br>Salt reduction program. | Behavioral: Salt reduction program<br>* 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.<br>|
| Active Comparator: Healthy lifestyle program<br>Healthy lifestyle program. | Behavioral: Healthy lifestyle program<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24-hour urinary sodium excretion | 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 | 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 | 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 | 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 | 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 |