Dietary Counseling to Reduce Salt Intake in Patients With High Blood Pressure

NCT02283697 | Completed

• 1 other identifier: 20142641
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

High salt diet increases risk of development of hypertension. In hypertensive patients, low salt diet decreases blood pressure. Not surprisingly public health authorities endorse low salt diet in hypertensive patients. But, surprisingly, average salt intake among adults in Canada remains stubbornly high. Low effectiveness of "fast counselling" by physicians and nurses on dietary salt is partly the culprit. Methods used in successful clinical trials (eg. provision of meals, community cooking sessions, many hours of counselling by dieticians) cannot be used in routine clinical practice. Hence the investigators propose a study on a pragmatic dietary counselling method suitable for clinical practice. Hypertensive patients will be randomized to receive standard care (which includes counselling by the usual healthcare team, including doctors and nurses) or to receive additional counselling from a registered dietician. This counselling will include two components: a one hour counselling session, and 4, once-weekly telephone calls. Effectiveness of this counselling will be measured by checking sodium in the urine from a 24 hour collection (which is a measure of dietary salt intake) at baseline and at 4 weeks. In addition, the investigators will also measure urinary sodium at 1 year, to assess if this effect of counselling persists over a longer time.

Conditions

Hypertension

Keywords

hypertension; high blood pressure; sodium; prevention; dietary sodium; salt

Outcome Measures

Primary Outcomes (2)

• Change in 24 hour urinary sodium excretion

  Change in 24-hour urine sodium at 4 weeks

  4 weeks

• Change in 24 hour urinary sodium excretion

  Change in 24-hour urine sodium at 12 months

  12 months

Secondary Outcomes (3)

• Change in 24 hour ambulatory blood pressure

  4 weeks and 12 months

• Change in 24 hour urinary potassium

  4 weeks and 12 months

• Change in body weight

  4 weeks and 12 months

Study Arms (2)

Dietary Counseling

EXPERIMENTAL

Apart from standard care, an additional one on one (family members allowed) one hour long counseling by certified dietician who will assess the patient's dietary habits, endorse and describe the Dietary Approach to Stop Hypertension (DASH) diet, and will establish four weekly half an hour follow ups by telephone to address compliance and any question raised by patient and family members.

Behavioral: Dietary Counseling

Control: Standard Care

OTHER

A standard endorsement of low salt diet and other non-pharmacological interventions such as moderation of alcohol intake, optimal body weight, daily exercise by hypertension nurse and physician

Other: Control: Standard Care

Interventions

Dietary Counseling BEHAVIORAL

a standard endorsement of low salt diet and other non-pharmacological interventions such as moderation of alcohol intake, optimal body weight, daily exercise by hypertension nurse and physician AND an additional one on one (family members allowed) one hour long counseling by certified dietician who will assess the patient's dietary habits, endorse and describe the Dietary Approach to Stop Hypertension (DASH) diet, and will establish four weekly half an hour follow ups by telephone to address compliance and any question raised by patient and family members.

Dietary Counseling

Control: Standard Care OTHER

a standard endorsement of low salt diet and other non-pharmacological interventions such as moderation of alcohol intake, optimal body weight, daily exercise by hypertension nurse and physician

Control: Standard Care

Eligibility Criteria

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

You may qualify if:

• Adult patients (\>18 years) with hypertension defined as
• daytime BP readings above 140/90 mmHg (as assessed from 24-hr ABPM)) without treatment and/or
• any patient with treated hypertension irrespective of BP load based on 24-hr ABPM.

You may not qualify if:

• Pregnant patients and
• patients with following conditions:
• glomerular filtration rate \<45 ml/min/1.75 m2,
• active infection,
• acute coronary syndrome,
• severe liver disease;
• psychiatric disorders and/or otherwise unable to sign consent;
• patients with clinically manifested generalized and/or cardiac volume overload who may require immediate changes in diuretic therapy (at the discretion of treating hypertension specialist).

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• The Ottawa Hospital Academic Medical Association: collaborator

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H7W9, Canada

Location

Related Publications (1)

• Ruzicka M, Ramsay T, Bugeja A, Edwards C, Fodor G, Kirby A, Magner P, McCormick B, van der Hoef G, Wagner J, Hiremath S. Does pragmatically structured outpatient dietary counselling reduce sodium intake in hypertensive patients? Study protocol for a randomized controlled trial. Trials. 2015 Jun 17;16:273. doi: 10.1186/s13063-015-0794-y.

  PMID: 26081765 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Marcel Ruzicka, MD PhD

  Ottawa Hospital research Insititute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2014
• First Posted: November 5, 2014
• Study Start: September 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 4, 2021

Record last verified: 2021-03

Locations

CA (1)