Blood PressureNCT03830021
Effect of a Multi-component Education Program on Salt Reduction in Adults
A study testing Salt reduction program and Healthy lifestyle program in people with Blood Pressure and Hypertension, run by Academia Cuf Descobertas at 2 sites in Portugal.
Trial summary
Excess salt intake is a major contributor to high blood pressure, the leading individual risk factor for cardiovascular events, such as stroke, myocardial infarction and heart failure. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Hypertension
- What is being tested?
- Salt reduction program and Healthy lifestyle program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 2 sitesPortugal
- Study dates
- 28 Jan 2019to 6 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults between the ages of 20 and 70.
- Subjects with or without hypertension, not medicated or medicated with medication and diet stabilized for at least 3 weeks.
- Responsible for the purchase and confection of their meals.
- Available to comply with study protocol and sign informed consent.
Who cannot join
- Pregnant, breastfeeding or planning to become pregnant within the study period.
- Subjects with current or previous cardiovascular disease (ischemic cardiovascular disease, angina stable or unstable; myocardial infarction, stroke or symptomatic peripheral arteriosclerosis).
- Subjects with liver or kidney diseases or cancer.
- Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to cooperate during the study.
- Subjects with special dietary needs.
- Health condition that prevents compliance with study requirements.
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites
Hospital CUF Infante Santo
Lisbon, 1350-070
Hospital CUF Descobertas
Lisbon, 1998-018
About this study
Excess salt intake is a major contributor to high blood pressure, the leading individual risk factor for cardiovascular events, such as stroke, myocardial infarction and heart failure. According to PHYSA study, salt intake in Portugal remains much higher (10.7 g) than recommended by the international health organisations, indicating the need for effective implementation of salt reduction interventions. In Portugal the main source of daily salt intake is added salt during cooking, and salt content in bread, cheese and processed meat.
The objective of this study is to determine the effectiveness of a dietary education program tailored for salt reduction. To assess the effectiveness of the salt reduction program the investigator's will measure changes in salt consumption levels, by evaluating the 24 h urinary sodium excretion.
This study is a consortium-initiated, randomised, simple-blinded, controlled trial designed to assess the effectiveness of a salt reduction program versus generic healthy lifestyle program in the Lisbon Metropolitan Area.
- Conditions
- Blood Pressure, Hypertension
- Being tested
- Salt reduction program, Healthy lifestyle program
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salt reduction programBehavioural
Dietary and behavioural change program, led by nutritionists, including low sodium dietary advice; use of aromatic herbs and spices in food instead of salt; motivational activities; food diaries; restrict salty processed foods; eat more fresh foods and seasoning advice; problem solving exercises; digital bulletins; individual counselling reinforced at each clinic visit and shopping counselling at local supermarket.
Healthy lifestyle programBehavioural
Participants receive an educational healthy lifestyle program that includes 1) methods to cook healthier and the Mediterranean diet based on a high intake of fresh fruit and, vegetables, beans, grain legumes, lentils, nuts, cereals, and olive oil as source of fat; moderate intake of fish, poultry, yoghurt and cheese, low intake of salt, red meat, processed meats and sugar; 2) physical activity; 3) drink more water and reducing alcohol consumption; and 4) sleep education.
| Study group | Role | What they receive |
|---|---|---|
| Salt reduction program | Experimental | Salt reduction program. Receives: Behavioral: Salt reduction program |
| Healthy lifestyle program | Active comparator | Healthy lifestyle program. Receives: Behavioral: Healthy lifestyle program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hour urinary sodium excretion
Difference between the intervention and control group in the change in 24-hour urinary sodium excretion from baseline to the end of follow-up.
Measured: 12 weeks
Secondary outcomes (4)
Change in systolic and diastolic blood pressure
Difference between the intervention and control group in the change in systolic and diastolic blood pressure from baseline to the end of follow-up.
Measured: 12 week
Change in weight
Difference between the intervention and control group in the change of weight from baseline to the end of follow-up.
Measured: 12 week
Change in waist circumference
Difference between the intervention and control group in the change of waist circumference from baseline to the end of follow-up.
Measured: 12 week
Change in salt content in foods purchased
Difference between the intervention and control group in the change of salt content in foods purchased from baseline to the end of follow-up.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start28 Jan 2019
- Primary completion6 Sep 2019
- Study completion6 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academia Cuf Descobertas
- Sponsor type
- Research network
- Collaborators
- CUF Academic and Research Medical Center, José de Mello Saúde, Pingo Doce, NOVA Medical School
- Responsible party
- Sponsor
- Investigators
- Jorge Polónia, PhD, Principal investigator, CINTESIS, Faculty of Medicine of the University of PortoConceição Calhau, PhD, Principal investigator, NOVA Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830021
- Sponsor's protocol ID
- ReEducSal001
- Status last verified
- Jan 2020
- First submitted
- 28 Jan 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Polonia J, Martins L, Pinto F, Nazare J. Prevalence, awareness, treatment and control of hypertension and salt intake in Portugal: changes over a decade. The PHYSA study. J Hypertens. 2014 Jun;32(6):1211-21. doi: 10.1097/HJH.0000000000000162.
PubMed 24675681Polonia J, Monteiro J, Almeida J, Silva JA, Bertoquini S. High salt intake is associated with a higher risk of cardiovascular events: a 7.2-year evaluation of a cohort of hypertensive patients. Blood Press Monit. 2016 Oct;21(5):301-6. doi: 10.1097/MBP.0000000000000205.
PubMed 27495189Polonia J, Lobo MF, Martins L, Pinto F, Nazare J. Estimation of populational 24-h urinary sodium and potassium excretion from spot urine samples: evaluation of four formulas in a large national representative population. J Hypertens. 2017 Mar;35(3):477-486. doi: 10.1097/HJH.0000000000001180.
PubMed 27898506Moreira-Rosario A, Ismael S, Barreiros-Mota I, Morais J, Rodrigues C, Castela I, Mendes IC, Soares MI, da Costa LS, Oliveira CB, Henriques T, Pinto P, Pita D, de Oliveira CM, Maciel J, Serafim T, Araujo J, Rocha JC, Pestana D, Silvestre MP, Marques C, Faria A, Polonia J, Calhau C. Empowerment-based nutrition interventions on blood pressure: a randomized comparative effectiveness trial. Front Public Health. 2023 Nov 13;11:1277355. doi: 10.3389/fpubh.2023.1277355. eCollection 2023.
PubMed 38026295
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Multi-component Education Program on Salt Reduction in Adults
- ClinicalTrials.gov ID
- NCT03830021
- Acronym / sponsor ID
- ReEducSal001
- Conditions
- Blood Pressure, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Academia Cuf DescobertasResearch network
- Collaborators
- CUF Academic and Research Medical Center, José de Mello Saúde, Pingo Doce, NOVA Medical School
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 6 Sep 2019 (actual)
- First posted
- 5 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Excess salt intake is a major contributor to high blood pressure, the leading individual risk factor for cardiovascular events, such as stroke, myocardial infarction and heart failure. According to PHYSA study, salt intake in Portugal remains much higher (10.7 g) than recommended by the international health organisations, indicating the need for effective implementation of salt reduction interventions. In Portugal the main source of daily salt intake is added salt during cooking, and salt content in bread, cheese and processed meat.
The objective of this study is to determine the effectiveness of a dietary education program tailored for salt reduction. To assess the effectiveness of the salt reduction program the investigator's will measure changes in salt consumption levels, by evaluating the 24 h urinary sodium excretion.
This study is a consortium-initiated, randomised, simple-blinded, controlled trial designed to assess the effectiveness of a salt reduction program versus generic healthy lifestyle program in the Lisbon Metropolitan Area.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salt reduction program | Experimental | Behavioral: Salt reduction programSalt reduction program. |
| Healthy lifestyle program | Active comparator | Behavioral: Healthy lifestyle programHealthy lifestyle program. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults between the ages of 20 and 70.
- Subjects with or without hypertension, not medicated or medicated with medication and diet stabilized for at least 3 weeks.
- Responsible for the purchase and confection of their meals.
- Available to comply with study protocol and sign informed consent.
Key exclusion criteria (6 listed)
- Pregnant, breastfeeding or planning to become pregnant within the study period.
- Subjects with current or previous cardiovascular disease (ischemic cardiovascular disease, angina stable or unstable; myocardial infarction, stroke or symptomatic peripheral arteriosclerosis).
- Subjects with liver or kidney diseases or cancer.
- Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to cooperate during the study.
- Subjects with special dietary needs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salt reduction programDietary and behavioural change program, led by nutritionists, including low sodium dietary advice; use of aromatic herbs and spices in food instead of salt; motivational activities; food diaries; restrict salty processed foods; eat more fresh foods and seasoning advice; problem solving exercises; digital bulletins; individual counselling reinforced at each clinic visit and shopping counselling at local supermarket. | Behavioural | Salt reduction program |
| Healthy lifestyle programParticipants receive an educational healthy lifestyle program that includes 1) methods to cook healthier and the Mediterranean diet based on a high intake of fresh fruit and, vegetables, beans, grain legumes, lentils, nuts, cereals, and olive oil as source of fat; moderate intake of fish, poultry, yoghurt and cheese, low intake of salt, red meat, processed meats and sugar; 2) physical activity; 3) drink more water and reducing alcohol consumption; and 4) sleep education. | Behavioural | Healthy lifestyle program |
Primary outcome
Change in 24-hour urinary sodium excretion
Time frame: 12 weeks
Difference between the intervention and control group in the change in 24-hour urinary sodium excretion from baseline to the end of follow-up.
4 secondary outcomes
Change in systolic and diastolic blood pressure
Time frame: 12 week
Change in weight
Time frame: 12 week
Change in waist circumference
Time frame: 12 week
Change in salt content in foods purchased
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Background: PubMed 24675681Polonia J, Martins L, Pinto F, Nazare J. Prevalence, awareness, treatment and control of hypertension and salt intake in Portugal: changes over a decade. The PHYSA study. J Hypertens. 2014 Jun;32(6):1211-21. doi: 10.1097/HJH.0000000000000162.
- Background: PubMed 27495189Polonia J, Monteiro J, Almeida J, Silva JA, Bertoquini S. High salt intake is associated with a higher risk of cardiovascular events: a 7.2-year evaluation of a cohort of hypertensive patients. Blood Press Monit. 2016 Oct;21(5):301-6. doi: 10.1097/MBP.0000000000000205.
- Background: PubMed 27898506Polonia J, Lobo MF, Martins L, Pinto F, Nazare J. Estimation of populational 24-h urinary sodium and potassium excretion from spot urine samples: evaluation of four formulas in a large national representative population. J Hypertens. 2017 Mar;35(3):477-486. doi: 10.1097/HJH.0000000000001180.
- Derived from this study: PubMed 38026295Moreira-Rosario A, Ismael S, Barreiros-Mota I, Morais J, Rodrigues C, Castela I, Mendes IC, Soares MI, da Costa LS, Oliveira CB, Henriques T, Pinto P, Pita D, de Oliveira CM, Maciel J, Serafim T, Araujo J, Rocha JC, Pestana D, Silvestre MP, Marques C, Faria A, Polonia J, Calhau C. Empowerment-based nutrition interventions on blood pressure: a randomized comparative effectiveness trial. Front Public Health. 2023 Nov 13;11:1277355. doi: 10.3389/fpubh.2023.1277355. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Polónia, PhD principal investigator
CINTESIS, Faculty of Medicine of the University of Porto
Conceição Calhau, PhD principal investigator
NOVA Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salt reduction program and Healthy lifestyle program in people with Blood Pressure and Hypertension, run by Academia Cuf Descobertas at 2 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24-hour urinary sodium excretion (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03830021, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.