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出境医 / 临床实验 / Study With an Innovative Equipment to Monitor and Control SALT During Cooking (iMC_SALT)

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

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 Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 1, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 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.
Outcome Measures
Primary Outcome Measures :
  1. Change from Baseline 24h urinary sodium excretion at during and after intervention [ Time Frame: 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 :
  1. Change from Baseline 24h urinary potassium excretion at during and after intervention [ Time Frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention ]
    Urinary potassium excretion as a proxy of dietary potassium intake

  2. Change from Baseline Systolic Blood Pressure at during and after intervention [ Time Frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention ]
    Systolic blood pressure

  3. Change from Baseline Diastolic Blood Pressure at during and after intervention [ Time Frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention ]
    Diastolic blood pressure

  4. Change from Baseline Hydration Status at during and after intervention [ Time Frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention ]
    urinary osmolality (mOsm/kg)

  5. Change from Baseline Perception of quality of life at during and after intervention [ Time Frame: 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

  6. Change from Baseline Culinary competences at during and after intervention [ Time Frame: 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

  7. Change from Baseline Intestinal Microbiota at after intervention [ Time Frame: Baseline and at 8th intervention week ]
    OTU (operational taxonomy unit) analysis (%)

  8. Change from Baseline Diet Quality at during and after intervention [ Time Frame: 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)

  9. Change from Baseline Knowledges, attitudes and behaviours about salt at during and after intervention [ Time Frame: 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 %)

  10. Change from Baseline Weight at during and after intervention [ Time Frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention ]
    Weight in kilograms

  11. Change from Baseline Height at during and after intervention [ Time Frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention ]
    Height in meters

  12. Change from Baseline Fat Mass and Fat Free Mass at during and after intervention [ Time Frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention ]
    Fat mass (in kg), Fat free mass (in kg)

  13. Change from Baseline Extra and intra cellular water at during and after intervention [ Time Frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention ]
    Extra and intra cellular water, basal metabolic rate

  14. Change from Baseline Extra and intra cellular water at during and after intervention [ Time Frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention ]
    Extra and intra cellular water (in kg)

  15. Change from Baseline Basal Metabolic Rate at during and after intervention [ Time Frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention ]
    Basal metabolic rate (in kcal)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Locations
Layout table for location information
Portugal
Carla Gonçalves
Porto, Portugal, 4200-465
Sponsors and Collaborators
Universidade do Porto
Fundação para a Ciência e a Tecnologia
Instituto Nacional de Saúde Doutor Ricardo Jorge
Centro Hospitalar De São João, E.P.E.
Investigators
Layout table for investigator information
Principal Investigator: Carla Gonçalves, PhD Researcher
Tracking Information
First Submitted Date  ICMJE April 29, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date January 8, 2021
Actual Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019) 		Change from Baseline 24h urinary sodium excretion at during and after intervention [ Time Frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention ]
Sodium excretion as a proxy of dietary salt intake
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • Change from Baseline 24h urinary potassium excretion at during and after intervention [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline and at 8th intervention week ]
    OTU (operational taxonomy unit) analysis (%)
  • Change from Baseline Diet Quality at during and after intervention [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention ]
    Basal metabolic rate (in kcal)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study With an Innovative Equipment to Monitor and Control SALT During Cooking
Official Title  ICMJE Randomized Controlled Trial With SALT CONTROL H - Impact on Individual Sodium and Sodium to Potassium Ratio Excretion
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Salt; Excess
  • Hypertension
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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!".
    Intervention: Device: SALT CONTROL H equipment to control and monitor salt during cooking process
  • 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.
Publications *
  • Gonçalves C, Abreu S, Padrão P, Pinho O, Graça P, Breda J, Santos R, Moreira P. Sodium and potassium urinary excretion and dietary intake: a cross-sectional analysis in adolescents. Food Nutr Res. 2016 Apr 11;60:29442. doi: 10.3402/fnr.v60.29442. eCollection 2016.
  • Gonçalves C, Monteiro S, Padrão P, Rocha A, Abreu S, Pinho O, Moreira P. Salt reduction in vegetable soup does not affect saltiness intensity and liking in the elderly and children. Food Nutr Res. 2014 Oct 6;58. doi: 10.3402/fnr.v58.24825. eCollection 2014.
  • Moreira P, Sousa AS, Guerra RS, Santos A, Borges N, Afonso C, Amaral TF, Padrão P. Sodium and potassium urinary excretion and their ratio in the elderly: results from the Nutrition UP 65 study. Food Nutr Res. 2018 Feb 27;62. doi: 10.29219/fnr.v62.1288. eCollection 2018.
  • Gonçalves C, Silva-Santos T, Abreu S, Padrão P, Graça P, Oliveira L, Esteves S, Norton P, Moreira P, Pinho O. Innovative equipment to monitor and control salt usage when cooking at home: iMC SALT research protocol for a randomised controlled trial. BMJ Open. 2020 May 17;10(5):e035898. doi: 10.1136/bmjopen-2019-035898.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 3, 2019) 		260
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Portugal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03974477
Other Study ID Numbers  ICMJE iMCSALT19-21
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: In order to promote the quality of the data, they will be introduced by an researcher with delegation of competences by the PI, a verification of double data entry and verification of outliers will be performed. The data will be used for publication of the results by the researchers of the project and for the accomplishment of master's and doctoral thesis.
Responsible Party Universidade do Porto
Study Sponsor  ICMJE Universidade do Porto
Collaborators  ICMJE
  • Fundação para a Ciência e a Tecnologia
  • Instituto Nacional de Saúde Doutor Ricardo Jorge
  • Centro Hospitalar De São João, E.P.E.
Investigators  ICMJE
Principal Investigator: Carla Gonçalves, PhD Researcher
PRS Account Universidade do Porto
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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