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| Name | Class |
|---|---|
| CUF Academic and Research Medical Center | UNKNOWN |
| José de Mello Saúde | UNKNOWN |
| Pingo Doce | UNKNOWN |
| NOVA Medical School |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salt reduction program | Experimental | Salt reduction program. |
|
| Healthy lifestyle program | Active Comparator | Healthy lifestyle program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Polónia, PhD | CINTESIS, Faculty of Medicine of the University of Porto | Principal Investigator |
| Conceição Calhau, PhD | NOVA Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital CUF Infante Santo | Lisbon | 1350-070 | Portugal | |||
| Hospital CUF Descobertas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24675681 | Background | 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. | |
| 27495189 | Background | 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. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
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|
| 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. |
|
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 |
| Lisbon |
| 1998-018 |
| Portugal |
| 27898506 | Background | 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. |
| 38026295 | Derived | Moreira-Rosario A, Ismael S, Barreiros-Mota I, Morais J, Rodrigues C, Castela I, Mendes IC, Soares MI, da Costa LS, Oliveira CB, Henriques T, Pinto P, Pita D, de Oliveira CM, Maciel J, Serafim T, Araujo J, Rocha JC, Pestana D, Silvestre MP, Marques C, Faria A, Polonia J, Calhau C. Empowerment-based nutrition interventions on blood pressure: a randomized comparative effectiveness trial. Front Public Health. 2023 Nov 13;11:1277355. doi: 10.3389/fpubh.2023.1277355. eCollection 2023. |