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

Not Applicable

Completed

• Conditions: Hypertension; Blood Pressure
• Interventions: Behavioral: Healthy lifestyle program; Behavioral: Salt reduction program

• Registration Number: NCT03830021
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-28
• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-05
• Primary Completion: 2019-09-06
• Study Completion: 2019-09-06
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 311

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy lifestyle program	Healthy lifestyle program	Healthy lifestyle program.
Salt reduction program	Salt reduction program	Salt reduction program.

Primary Outcome Measures

Name	Time	Method
Change in 24-hour urinary sodium excretion	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.

Secondary Outcome Measures

Name	Time	Method
Change in weight	12 week	Difference between the intervention and control group in the change of weight from baseline to the end of follow-up.
Change in waist circumference	12 week	Difference between the intervention and control group in the change of waist circumference from baseline to the end of follow-up.
Change in systolic and diastolic blood pressure	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.
Change in salt content in foods purchased	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.

Trial Locations

Locations (2)

Hospital CUF Infante Santo; 🇵🇹 Lisbon, Portugal

Hospital CUF Descobertas; 🇵🇹 Lisbon, Portugal