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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03830021
• Other study ID #: ReEducSal001
• Status: Completed
• Phase: N/A
• Start date: January 28, 2019
• Est. completion date: September 6, 2019

Study information

• Verified date: January 2020
• Source: Academia Cuf Descobertas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: September 6, 2019
• Est. primary completion date: September 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension

Intervention

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.
• 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.

Locations

Country	Name	City	State
Portugal	Hospital CUF Descobertas	Lisbon
Portugal	Hospital CUF Infante Santo	Lisbon

Sponsors (5)

Lead Sponsor	Collaborator
Academia Cuf Descobertas	CUF Academic and Research Medical Center, José de Mello Saúde, NOVA Medical School, Pingo Doce

Country where clinical trial is conducted

Portugal, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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