Study With an Innovative Equipment to Monitor and Control SALT During Cooking (iMC_SALT)

Universidade do Porto

Status: Unknown

Conditions: Hypertension; Salt; Excess

Treatments: Device: SALT CONTROL H equipment to control and monitor salt during cooking process

Study type: Interventional

Funder types: Other

Identifiers

NCT03974477

iMCSALT19-21

Details and patient eligibility

About

In this study, the researchers will evaluate the efficacy of an intervention using the SALT CONTROL H instrument (an innovative equipment to monitor and control salt) in workers at the University of Porto to reduce dietary salt intake. This is a randomized clinical trial with intervention conducted according to good clinical practice guidelines.

The researchers will randomize 260 workers who meet the eligibility criteria and are enrolled in occupational health appointments. Prior to the intervention, the informed consent of the participants will be obtained and those who agree to participate will be allocated randomly in one of the two arms of the study (control or intervention), with balance of baseline characteristics (sex and hypertension).

The intervention will last for 8 weeks, an individual session of presentation of SALT CONTROL H will be carried out, with explanation of how the equipment works in the culinary preparation with an adequate salt content, will be used an illustrative video and recipes with an adequate salt content; use of SALT CONTROL H at home by the participant to control the use of salt during the cooking process; supervision and enhancement of the use of equipment; daily occurrence log; and the application of a satisfaction questionnaire on the use of SALT CONTROL H. A leaflet will also be delivered about "The new Food Wheel, a guide to the daily food choice!".

Control Group: No intervention will be carried out except the provision of a leaflet on "The new Food Wheel, a guide to the daily food choice!" to the participants.

Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention analysis will cover the following domains: urinary sodium excretion corresponding to a 24 hour urine collection as a proxy for salt intake; 24-hour urinary potassium excretion, sodium:potassium ratio, systolic and diastolic blood pressure, and anthropometric measurements. Urine samples will be collected according to standardized procedures and analyzed by a certified laboratory. Secondary data such as satisfaction questionnaire, daily use of equipment, iodine analysis of salt used and excreted in urine 24h, hydration status, analysis of quality of life and quality of diet will also be analyzed, as well as intestinal microbiota.

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults (> 18 years)
• Eat frequently cooked meals at home (> 4 days a week, of which at least 3 Sundays / month)
• Have an occupational health appoitments at São João Hospital
• Reported motivation to control salt consumption

Exclusion criteria

• Pregnant
• Subjects with kidney disease,
• Subjects with active infection with an impact on renal function,
• Subjects with urinary incontinence,
• Subjects with acute coronary syndrome,
• Subjects with severe liver disease;
• Subjects with heart failure;
• Subjects who do not use salt for cooking;
• Subjects with hypotension;
• Subjects that work at Faculty that are the Sponsor of the study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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260 participants in 2 patient groups

Intervention

Experimental group

Description:

The intervention will last for 8 weeks, an individual session of presentation of SALT CONTROL H will be carried out, with explanation of how the equipment works in the culinary preparation with an adequate salt content (will be used an illustrative video and recipes with an adequate salt content); use of SALT CONTROL H at home by the participant to control the use of salt during the cooking process; supervision and enhancement of the use of equipment; daily occurrence log; and the application of a satisfaction questionnaire on the use of SALT CONTROL H. A leaflet will also be delivered about "The new Food Wheel, a guide to the daily food choice!".

Treatment:

Device: SALT CONTROL H equipment to control and monitor salt during cooking process

Control

No Intervention group

Description:

No intervention will be carried out except the provision of a leaflet on "The new Food Wheel, a guide to the daily food choice!" to the participants.