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

Universidade do Porto260 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from Baseline 24h urinary sodium excretion at during and after intervention

Sodium excretion as a proxy of dietary salt intake

Time frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention

Secondary Outcomes

Change from Baseline 24h urinary potassium excretion at during and after intervention

Urinary potassium excretion as a proxy of dietary potassium intake

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: Baseline, at 8th intervention week, and 6 months after intervention

Change from Baseline Intestinal Microbiota at after intervention

OTU (operational taxonomy unit) analysis (%)

Time frame: 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)

Time frame: 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 %)

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes