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

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Trial With SALT CONTROL H - Impact on Individual Sodium and Sodium to Potassium Ratio Excretion

Conditions
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Salt; Excess, Hypertension

Intervention / Treatment
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* Device: SALT CONTROL H equipment to control and monitor salt during cooking process


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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!. | Device: SALT CONTROL H equipment to control and monitor salt during cooking process<br>* Participants will use SALT CONTROL H at home during 8 weeks to cook meals with adequate salt content.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline 24h urinary sodium excretion at during and after intervention | Sodium excretion as a proxy of dietary salt intake | Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline 24h urinary potassium excretion at during and after intervention | Urinary potassium excretion as a proxy of dietary potassium intake | Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention | 
| Change from Baseline Systolic Blood Pressure at during and after intervention | Systolic blood pressure | Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention | 
| Change from Baseline Diastolic Blood Pressure at during and after intervention | Diastolic blood pressure | Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention | 
| Change from Baseline Hydration Status at during and after intervention | urinary osmolality (mOsm/kg) | Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention | 
| Change from Baseline Perception of quality of life at during and after intervention | Questionnaire WHOQOL-BREF, results from 0 to 100, higher values represent better perception of quality of life | Baseline, at 8th intervention week, and 6 months after intervention | 
| Change from Baseline Culinary competences at during and after intervention | Questionnaire, questions scales from 1 to 6 according to culinary competences, higher values represent better culinary competences | Baseline, at 8th intervention week, and 6 months after intervention | 
| Change from Baseline Intestinal Microbiota at after intervention | OTU (operational taxonomy unit) analysis (%) | Baseline and at 8th intervention week | 
| Change from Baseline Diet Quality at during and after intervention | HDI (Healthy Diet Indicator), HDI-2015 was calculated as the sum of 7 components (range 0-7) and was classified as follows: high adherence (met 6-7 components), moderate adherence (met 4-5 components), and low adherence (met 0-3 components) | Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention | 
| Change from Baseline Knowledges, attitudes and behaviours about salt at during and after intervention | Questionnaire on Knowledge, Attitudes, Behavior toward Dietary Salt and Health from PAHO (n and %) | Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention | 
| Change from Baseline Weight at during and after intervention | Weight in kilograms | Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention | 
| Change from Baseline Height at during and after intervention | Height in meters | Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention | 
| Change from Baseline Fat Mass and Fat Free Mass at during and after intervention | Fat mass (in kg), Fat free mass (in kg) | Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention | 
| Change from Baseline Extra and intra cellular water at during and after intervention | Extra and intra cellular water, basal metabolic rate | Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention | 
| Change from Baseline Extra and intra cellular water at during and after intervention | Extra and intra cellular water (in kg) | Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention | 
| Change from Baseline Basal Metabolic Rate at during and after intervention | Basal metabolic rate (in kcal) | Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary Salt, Urinary sodium excretion, Cooking, Hypertension, Randomized Controlled Trial, Sodium, Diet, Patient Education