Salt Intake and Blood Pressure Control in Adults With Essential Hypertension

NCT07025928 | Recruiting

• 2 other identifiers: 2025-0006SHP-CG-CRGNov24-A05
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to explore the barriers and facilitators to adopting a reduced dietary salt and increased potassium intake among adults with essential hypertension in Singapore, and to evaluate the feasibility and preliminary effectiveness of a newly developed educational tool-Decreased Salt High Potassium (DSHP) Diet Tool-in reducing dietary sodium intake and increasing potassium intake. This three-part study will involve adults aged 21 years and above, with a self-reported diagnosis of hypertension for at least six months and/or currently taking antihypertensive medication. Participants will be recruited from two SingHealth Polyclinics (Punggol Polyclinic and Pasir Ris Polyclinic). Healthcare providers (HCPs) working at these clinics who have experience in managing patients with hypertension and in educating patients on reducing dietary sodium intake will also be recruited. The main questions this study aims to answer are:

• What are the perceived barriers and facilitators for patients with hypertension to reduce dietary sodium and increase potassium intake?
• What are the perceived barriers and facilitators experienced by healthcare providers in educating patients about sodium reduction and potassium intake?
• Is the DSHP Diet Tool feasible and effective in reducing dietary sodium intake and increasing potassium intake among patients with hypertension? Participants in the intervention group will be provided DSHP Diet Tool and Decreased Salt High Potassium patient information leaflet (DSHP PIL). Participants in the control group will receive standard care and a patient information leaflet (DSHP PIL). Researchers will compare participants in the intervention group to the control group to determine whether the DSHP tool is effective in reducing dietary sodium and increasing potassium intake in patients with hypertension.

Conditions

Hypertension

Keywords

Hypertension; sodium reduction; increased potassium intake; reduced salt; blood pressure control; primary care; Singapore; educational intervention

Outcome Measures

Primary Outcomes (2)

• 24 hour Urinary Sodium level

  24 hour urinary sodium level will be assessed at baseline and at the end of the intervention

  At baseline and at the end of the intervention (24 weeks)

• 24 hour urinary potassium level

  24 hour urinary potassium level will be measured at baseline and at the end of intervention (24 weeks)

  at baseline and at the end of intervention (24 weeks)

Secondary Outcomes (4)

• Blood pressure

  at baseline and at the end of intervention (24 weeks)

• Body mass index

  at baseline and at the end of 24 weeks

• Salt literacy scale

  At baseline and at the end of intervention (24 weeks)

• DASH score

  at baseline and at the end of intervention (24 weeks)

Study Arms (2)

DSHP Diet Tool and DSHP Patient information leaflet

EXPERIMENTAL

Participants in this arm will receive standard hypertension care along with access to the Decreased Salt High Potassium (DSHP) Diet Tool for 24 weeks and DSHP Patient information leaflet. The DSHP Tool is a patient-centered educational resource developed to support sodium reduction and increase potassium intake through practical strategies, goal setting, and food guidance. Participants will also receive the DSHP Patient Information Leaflet (PIL). Patients will be guided on how to use the tool by a study coordinator. Clinical and dietary assessments will be conducted at baseline and at the end of the intervention.

Behavioral: Decreased Salt High Potassium Tool (DSHP Tool)

Standard Care + DSHP Patient Information Leaflet

NO INTERVENTION

Participants in this arm will receive standard hypertension care as provided at SingHealth Polyclinics, along with the DSHP Patient Information Leaflet (PIL). The PIL provides written guidance on reducing sodium and increasing potassium intake. No access to the DSHP Tool will be provided in this arm. Participants will undergo the same clinical and dietary assessments as the intervention group at baseline and after 24 weeks.

Interventions

Decreased Salt High Potassium Tool (DSHP Tool) BEHAVIORAL

Participants in this arm will receive standard hypertension care and the Decreased Salt High Potassium (DSHP)Tool for 24 weeks. The DSHP Tool is an educational resource which includes a sodium intake calculator and tracker, potassium-rich food lists, risk matrix visuals, goal-setting modules tailored to the Singaporean diet. Participants will also receive the DSHP Patient Information Leaflet (PIL) .

DSHP Diet Tool and DSHP Patient information leaflet

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who are 21 years old and above.
• Participants who self-reports to have hypertension for at least six months and/ or taking at least one type of antihypertensive medication daily for at least six months
• Able to read English

You may not qualify if:

• Participants with type 1/ type 2 or secondary diabetes mellitus
• Participants with CKD stage 3B and above
• Participants with serum potassium of above 4.5mmol/L (on the latest blood test)
• Participants with serum sodium of less than 135 mmol/L (on the latest blood test)
• Participants who are on daily potassium chloride
• Participants who are on diuretics (thiazide or thiazide like diuretics)
• Participants who are pregnant
• Participants who had been diagnosed with any terminal illnesses, visually impaired, disability or mental health related illnesses (visually impaired refers to individuals who self-report to have difficulty reading the wordings on the patient consent form, even with the use of visual aids)
• Participants who are not clinically stable (Clinically stable patients are defined in this study as:
• Has clinic BP 100-160/60-100 mmHg, Heart Rate (HR) 60-100 bpm
• No recent hospitalizations (within the last 3 months) due to hypertensive emergencies, strokes, myocardial infarctions or other acute cardiovascular events
• HCPs who had prior experience in advising patients on dietary salt reduction
• HCPs who self-reported to have ever treated patients with hypertension
• nil

Sponsors & Collaborators

• Sun Jingfeng: lead

Study Sites (1)

Jingfeng Sun

Singapore, Singapore, 820681, Singapore

RECRUITING

Related Publications (12)

• Silva-Santos T, Moreira P, Rodrigues M, Padrao P, Pinho O, Norton P, Ndrio A, Goncalves C. Interventions That Successfully Reduced Adults Salt Intake-A Systematic Review. Nutrients. 2021 Dec 21;14(1):6. doi: 10.3390/nu14010006.

  PMID: 35010883 BACKGROUND

• Cheong SM, Ambak R, Othman F, He FJ, Salleh R, Mohd Sallehudin S, Palaniveloo L, Ganapathy SS. Knowledge, perception, and practice related to sodium intake among Malaysian adults: findings from the Malaysian Community Salt Study (MyCoSS). J Health Popul Nutr. 2021 May 31;40(Suppl 1):5. doi: 10.1186/s41043-021-00231-4.

  PMID: 34059162 BACKGROUND

• Chan CMJ, Dickens BSL, Chong MF. Understanding knowledge, attitudes and behaviours related to dietary sodium intake in a multi-ethnic population in Singapore. Public Health Nutr. 2023 Dec;26(12):2802-2814. doi: 10.1017/S1368980023002422. Epub 2023 Nov 3.

  PMID: 37921207 BACKGROUND

• Aaron KJ, Sanders PW. Role of dietary salt and potassium intake in cardiovascular health and disease: a review of the evidence. Mayo Clin Proc. 2013 Sep;88(9):987-95. doi: 10.1016/j.mayocp.2013.06.005.

  PMID: 24001491 BACKGROUND

• Ekmekcioglu C, Elmadfa I, Meyer AL, Moeslinger T. The role of dietary potassium in hypertension and diabetes. J Physiol Biochem. 2016 Mar;72(1):93-106. doi: 10.1007/s13105-015-0449-1. Epub 2015 Dec 3.

  PMID: 26634368 BACKGROUND

• Koh J, Ang G, Tan KB, Chen C. The social cost of high sodium diet in Singapore. Br J Nutr. 2023 May 14;129(9):1598-1606. doi: 10.1017/S0007114522001568. Epub 2022 May 26.

  PMID: 35614498 BACKGROUND

• Bibbins-Domingo K, Chertow GM, Coxson PG, Moran A, Lightwood JM, Pletcher MJ, Goldman L. Projected effect of dietary salt reductions on future cardiovascular disease. N Engl J Med. 2010 Feb 18;362(7):590-9. doi: 10.1056/NEJMoa0907355. Epub 2010 Jan 20.

  PMID: 20089957 BACKGROUND

• Pimenta E, Gaddam KK, Oparil S, Aban I, Husain S, Dell'Italia LJ, Calhoun DA. Effects of dietary sodium reduction on blood pressure in subjects with resistant hypertension: results from a randomized trial. Hypertension. 2009 Sep;54(3):475-81. doi: 10.1161/HYPERTENSIONAHA.109.131235. Epub 2009 Jul 20.

  PMID: 19620517 BACKGROUND

• He FJ, Li J, Macgregor GA. Effect of longer-term modest salt reduction on blood pressure. Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD004937. doi: 10.1002/14651858.CD004937.pub2.

  PMID: 23633321 BACKGROUND

• Grillo A, Salvi L, Coruzzi P, Salvi P, Parati G. Sodium Intake and Hypertension. Nutrients. 2019 Aug 21;11(9):1970. doi: 10.3390/nu11091970.

  PMID: 31438636 BACKGROUND

• Adrogue HJ, Madias NE. Sodium and potassium in the pathogenesis of hypertension. N Engl J Med. 2007 May 10;356(19):1966-78. doi: 10.1056/NEJMra064486. No abstract available.

  PMID: 17494929 BACKGROUND

• Vaduganathan M, Mensah GA, Turco JV, Fuster V, Roth GA. The Global Burden of Cardiovascular Diseases and Risk: A Compass for Future Health. J Am Coll Cardiol. 2022 Dec 20;80(25):2361-2371. doi: 10.1016/j.jacc.2022.11.005. Epub 2022 Nov 9. No abstract available.

  PMID: 36368511 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

SUN JINGFENG, Masters in Medicine(Fam Med)

CONTACT

+6591390121; jingfengsun88@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be masked to group allocation. While both groups will receive educational materials, participants in the control arm will not be informed that the Patient Information Leaflet (PIL) is the comparator intervention. This design minimizes expectancy bias by ensuring participants are unaware of whether they are receiving the "active" DSHP Diet Tool or the control material. Outcome assessors analyzing biochemical and clinical data will also be masked to group allocation to reduce detection bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Family Physician

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: June 18, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): July 31, 2030
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)