title: Does pragmatically structured outpatient dietary counselling reduce sodium intake in hypertensive patients? Study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Hypertension is highly prevalent among adults, and is the most important modifiable risk factor for cardiovascular events, in particular stroke. Decreasing sodium intake has the potential to prevent or delay the development of hypertension and improve blood pressure control, independently of blood pressure lowering drugs, among hypertensive patients. Despite guidelines recommending a low sodium diet, especially for hypertensive individuals, sodium intake remains higher than recommended. A recent systematic review indicated that the efficacious counselling methods described in published trials are not suitable for hypertension management by primary care providers in Canada in the present form. The primary reason for the lack of feasibility is that interventions for sodium restriction in these trials was not limited to counselling, but included provision of food, prepared meals, or intensive inpatient training sessions.
  
  
  METHODS
  This is a parallel, randomized, controlled, open-label trial with blinded endpoints. Inclusion criteria are adult patients with hypertension with high dietary sodium intake (defined as ≥ 100 mmol/day). The control arm will receive usual care, and the intervention arm will receive usual care and an additional structured counselling session by a registered dietitian, with four follow-up telephone support sessions over four weeks. The two primary outcomes are change in sodium intake from baseline, as measured by a change in 24-hour urinary sodium measurements at four weeks and one year. Secondary outcomes include change in blood pressure (as measured by 24-hour ambulatory monitoring), change in 24-hour urinary potassium, and change in body weight at the same time points.
  
  
  CONCLUSIONS
  Though decreasing sodium intake has been reported to be efficacious in lowering blood pressure, there exists a gap in the evidence for an effective intervention that could be easily translated into clinical practice. If successful, our intervention would be suitable for outpatient programs such as hypertension clinics or interprofessional family practices (family health teams). A negative, or partially negative (positive effect at four weeks with attrition by 12 months) trial outcome also has significant implications for healthcare delivery and use of resources.
  
  
  BACKGROUND
  The trial was registered with Clinicaltrials.gov (identifier: NCT02283697) on 2 November 2014.
authors.affiliation: Division of Nephrology, The Ottawa Hospital and the University of Ottawa, 5-11 1967 Riverside Drive, Ottawa, ON, K1H7W9, Canada. mruzicka@toh.on.ca.
authors.forename: Marcel
authors.initials: M
authors.lastname: Ruzicka
authors.affiliation: Clinical Epidemiology Program, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, ON, K1H8L6, Canada. tramsay@ohri.ca.
authors.forename: Tim
authors.initials: T
authors.lastname: Ramsay
authors.affiliation: Division of Nephrology, The Ottawa Hospital and the University of Ottawa, 5-11 1967 Riverside Drive, Ottawa, ON, K1H7W9, Canada. abugeja@toh.on.ca.
authors.forename: Ann
authors.initials: A
authors.lastname: Bugeja
authors.affiliation: Division of Nephrology, The Ottawa Hospital and the University of Ottawa, 5-11 1967 Riverside Drive, Ottawa, ON, K1H7W9, Canada. ceedwards@toh.on.ca.
authors.forename: Cedric
authors.initials: C
authors.lastname: Edwards
authors.affiliation: Prevention and Rehabilitation Centre, University of Heart Institute, 40 Ruskin Street, Ottawa, ON, K1Y4W7, Canada. George.fodor@gmail.com.
authors.forename: George
authors.initials: G
authors.lastname: Fodor
authors.affiliation: Division of Nephrology, The Ottawa Hospital and the University of Ottawa, 5-11 1967 Riverside Drive, Ottawa, ON, K1H7W9, Canada. akirby@toh.on.ca.
authors.forename: Anne
authors.initials: A
authors.lastname: Kirby
authors.affiliation: Division of Nephrology, The Ottawa Hospital and the University of Ottawa, 5-11 1967 Riverside Drive, Ottawa, ON, K1H7W9, Canada. pmagner@toh.on.ca.|Kidney Research Centre, The Ottawa Hospital, 1967 Riverside Drive, Ottawa, ON, K1H7W9, Canada. pmagner@toh.on.ca.
authors.forename: Peter
authors.initials: P
authors.lastname: Magner
authors.affiliation: Division of Nephrology, The Ottawa Hospital and the University of Ottawa, 5-11 1967 Riverside Drive, Ottawa, ON, K1H7W9, Canada. bmccormick@toh.on.ca.
authors.forename: Brendan
authors.initials: B
authors.lastname: McCormick
authors.affiliation: Kidney Research Centre, The Ottawa Hospital, 1967 Riverside Drive, Ottawa, ON, K1H7W9, Canada. gvandenhoef@toh.on.ca.
authors.forename: Gigi
authors.initials: G
authors.lastname: van der Hoef
authors.affiliation: Kidney Research Centre, The Ottawa Hospital, 1967 Riverside Drive, Ottawa, ON, K1H7W9, Canada. jewagner@toh.on.ca.
authors.forename: Jessica
authors.initials: J
authors.lastname: Wagner
authors.affiliation: Division of Nephrology, The Ottawa Hospital and the University of Ottawa, 5-11 1967 Riverside Drive, Ottawa, ON, K1H7W9, Canada. shiremath@toh.on.ca.|Kidney Research Centre, The Ottawa Hospital, 1967 Riverside Drive, Ottawa, ON, K1H7W9, Canada. shiremath@toh.on.ca.|Clinical Epidemiology Program, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, ON, K1H8L6, Canada. shiremath@toh.on.ca.
authors.forename: Swapnil
authors.initials: S
authors.lastname: Hiremath
mesh_terms: D000553:Ambulatory Care; D015415:Biomarkers / Q000652:urine; D001794:Blood Pressure; D018660:Blood Pressure Monitoring, Ambulatory; D001835:Body Weight; D002985:Clinical Protocols; D003376:Counseling; D004039:Diet, Sodium-Restricted; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000178:diet therapy* / Q000209:etiology / Q000503:physiopathology / Q000523:psychology; D009864:Ontario; D010353:Patient Education as Topic; D011188:Potassium / Q000652:urine; D012107:Research Design; D040242:Risk Reduction Behavior; D017673:Sodium Chloride, Dietary / Q000009:adverse effects*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D017673:Sodium Chloride, Dietary; D011188:Potassium