NCT03830021

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
311

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

January 28, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2019

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

January 28, 2019

Last Update Submit

January 9, 2020

Conditions

Blood PressureHypertension

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (4)

  • Change in systolic and diastolic blood pressure

    12 week

  • Change in weight

    12 week

  • Change in waist circumference

    12 week

  • Change in salt content in foods purchased

    12 weeks

Study Arms (2)

Salt reduction program

EXPERIMENTAL

Salt reduction program.

Behavioral: Salt reduction program

Healthy lifestyle program

ACTIVE COMPARATOR

Healthy lifestyle program.

Behavioral: Healthy lifestyle program

Interventions

Salt reduction programBEHAVIORAL

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.

Salt reduction program
Healthy lifestyle programBEHAVIORAL

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.

Healthy lifestyle program

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital CUF Infante Santo

Lisbon, 1350-070, Portugal

Location

Hospital CUF Descobertas

Lisbon, 1998-018, Portugal

Location

Related Publications (4)

  • 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.

    PMID: 24675681BACKGROUND

  • Polonia 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.

    PMID: 27495189BACKGROUND

  • Polonia 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.

    PMID: 27898506BACKGROUND

  • Moreira-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.

    PMID: 38026295DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Jorge Polónia, PhD

    CINTESIS, Faculty of Medicine of the University of Porto

    PRINCIPAL INVESTIGATOR

  • Conceição Calhau, PhD

    NOVA Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2019

First Posted

February 5, 2019

Study Start

January 28, 2019

Primary Completion

September 6, 2019

Study Completion

September 6, 2019

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations

PT(2)