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

Sponsor

Universidade do Porto (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03974477

Collaborator

Fundação para a Ciência e a Tecnologia (Other), Instituto Nacional de Saúde Doutor Ricardo Jorge (Other), Centro Hospitalar De São João, E.P.E. (Other)

260

Enrollment

Location

Arms

Anticipated Duration (Months)

11.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Salt; Excess Hypertension	Device: SALT CONTROL H equipment to control and monitor salt during cooking process	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

260 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 1, 2019

Anticipated Primary Completion Date :

Mar 31, 2021

Anticipated Study Completion Date :

Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention 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 Participants will use SALT CONTROL H at home during 8 weeks to cook meals with adequate salt content.
No Intervention: Control 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.

Arm

Intervention/Treatment

Experimental: Intervention

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

Participants will use SALT CONTROL H at home during 8 weeks to cook meals with adequate salt content.

No Intervention: Control

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.

Outcome Measures

Primary Outcome Measures

Change from Baseline 24h urinary sodium excretion at during and after intervention [Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention]
Sodium excretion as a proxy of dietary salt intake

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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