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

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

Sponsors

Lead Sponsor: Academia Cuf Descobertas

Collaborator: CUF Academic and Research Medical Center
José de Mello Saúde
Pingo Doce
NOVA Medical School

Source Academia Cuf Descobertas
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.

Overall Status Completed
Start Date January 28, 2019
Completion Date September 6, 2019
Primary Completion Date September 6, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in 24-hour urinary sodium excretion 12 weeks
Secondary Outcome
Measure Time Frame
Change in systolic and diastolic blood pressure 12 week
Change in weight 12 week
Change in waist circumference 12 week
Change in salt content in foods purchased 12 weeks
Enrollment 311
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Salt reduction program

Description: 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.

Arm Group Label: Salt reduction program

Intervention Type: Behavioral

Intervention Name: Healthy lifestyle program

Description: 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.

Arm Group Label: Healthy lifestyle program

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.

Gender: All

Minimum Age: 20 Years

Maximum Age: 70 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Location
Facility:
Hospital CUF Infante Santo | Lisbon, 1350-070, Portugal
Hospital CUF Descobertas | Lisbon, 1998-018, Portugal
Location Countries

Portugal

Verification Date

January 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Salt reduction program

Type: Experimental

Description: Salt reduction program.

Label: Healthy lifestyle program

Type: Active Comparator

Description: Healthy lifestyle program.

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Single (Participant)

Source: ClinicalTrials.gov