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Does pragmatically structured outpatient dietary counselling reduce sodium intake in hypertensive patients? Study protocol for a randomized controlled trial.

ABSTRACT: 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.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.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.The trial was registered with Clinicaltrials.gov (identifier: NCT02283697) on 2 November 2014.

SUBMITTER: Ruzicka M

PROVIDER: S-EPMC4479223 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Does pragmatically structured outpatient dietary counselling reduce sodium intake in hypertensive patients? Study protocol for a randomized controlled trial.

Ruzicka Marcel M Ramsay Tim T Bugeja Ann A Edwards Cedric C Fodor George G Kirby Anne A Magner Peter P McCormick Brendan B van der Hoef Gigi G Wagner Jessica J Hiremath Swapnil S

Trials 20150617

<h4>Background</h4>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 re ...[more]

PMID: 26081765

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Project description:BackgroundSalt intake of schoolchildren in the Australian state of Victoria is high. To protect future cardiovascular health, interventions that seek to reduce the amount of salt in children's diets are required.ObjectiveWe sought to develop and pilot test a Web-based program (Digital Education to Limit Salt Intake in the Home [DELISH]) that aims to reduce dietary salt intake among schoolchildren and to improve child and parent knowledge, attitudes, and behaviors related to salt intake. This paper presents the DELISH study protocol, along with pilot findings used to inform the development of the program.MethodsThe DELISH program is a 5-week Web-based intervention that targets schoolchildren aged 7-10 years and their parents. This is a single-arm study with a pretest and posttest design. We will assess change in salt intake through analysis of 24-hour urinary sodium excretion. Children and parents will complete online surveys assessing knowledge, attitudes, and behaviors related to salt intake. We will assess feasibility of the program via process measures, which include metrics to describe intervention uptake (eg, number of children who complete Web-based sessions and of parents who view online newsletters) and evaluation surveys and interviews conducted with children, parents, and schoolteachers. The first 2 Web sessions developed for children were pilot tested in 19 children aged 8-12 years.ResultsFindings from pilot testing indicated that most children (session 1: 18/19, 95%; and session 2: 19/19, 100%) enjoyed completing each session and liked the inclusion of comic strips and interactive games. Commonly reported areas of improvement related to sessions being text and content heavy. Based on these findings, we simplified sessions and developed 3 additional sessions for use in the DELISH program. The DELISH program was implemented during June-December 2016. We expect to have results from this study at the end of 2017.ConclusionsTo our knowledge, this is the first Australian study to examine the effectiveness of a Web-based program to reduce salt intake among children in primary school. If shown to be acceptable and effective in lowering salt intake, the DELISH program could be tested using a more rigorous randomized controlled trial design.

Project description:IntroductionAccurate sodium intake estimates in adults with elevated blood pressure are essential for monitoring salt reduction progress and preventing cardiovascular diseases. However, sodium assessments are challenging in this high-risk population because many commonly used antihypertensive drugs alter urinary sodium excretion. Despite the high cost and substantial participant burden of gold-standard 24-hour urine collection, the relative performance of existing spot-urine based equations and dietary self-report instruments have not been well studied in this population, who will benefit from salt restriction. This systematic review aims to describe the current methods of assessing dietary sodium intake in adults with elevated blood pressure and determine what method can provide a valid and accurate estimate of sodium intake compared with the gold standard 24-hour urine collection.Methods and analysisStudies assessing sodium intake in adults aged 18 years and above with reported elevated blood pressure will be included. Five electronic databases (MEDLINE, Embase, Global Health, WoS and Cochrane CENTRAL) will be systematically searched from inception to March 2021. Also, a manual search of bibliographies and grey literature will be conducted. Two reviewers will screen the records independently for eligibility. One reviewer will extract all data, and two others will review the extracted data for accuracy. The methodological quality of included studies will be evaluated based on three scoring systems: (1) National Heart, Lung and Blood Institute for interventional studies; (2) Biomarker-based Cross-sectional Studies for biomarker-based observational studies and (3) European Micronutrient Recommendation Aligned Network of Excellence for validation studies of dietary self-report instruments.Ethics and disseminationAs the proposed systematic review will collect and analyse secondary data associated with individuals, there will be no ethical approval requirement. Findings will be disseminated in a peer-reviewed journal or presented at a conference.Prospero registration numberCRD42020176137.

Project description:BackgroundHypertension and its complications are among the major health problems all over the world, particularly in developing countries. The aims of this study were to show that, weather the hypertensive patients follow the expertise recommendations and differences between men and women in their levels of knowledge and behavior in salt taking.MethodsThe present cross-sectional study was conducted among all hypertensive patients in rural health centers of Tabriz, Iran, in Feb-May; 2016. Data were collected by an interviewer-administrated questionnaire, along with anthropometric, blood pressure, and 24-hour urinary sodium excretion measurements. Multivariate logistic regression analysis was used to compute adjusted odds ratio (OR).ResultsIn all 205 patients, 62.9% female, 40.5% aged over 60 years, and 53.7% with low or moderate socioeconomic status, 49.3% body mass index (BMI) 30 kg/m2 and above, 10.2% of the patients had systolic/diastolic equal and above (≥) 40/90 mmHg, participated in the study. In total, 16.6% were aware of the daily salt allowance for healthy people with sex difference (P < 0.001). Significant predictors of adding salt beyond the dietary recommendations in food preparation were occupation (unemployed) (OR = 4.05, 95% CI = 1.041-15.78, (P = 0.044)) and blood pressure level (systolic/diastolic ≥140/90) (OR = 2.76, 95% CI = 1.28-5.96 (P = 0.010)), while adding salt at the table correlated with sex (men) (OR = 4.47, 95% CI = 1.21-16.57 (P = 0.025)), age (54-59) (OR = 0.05 95% CI = 0.01-0.39, (P = 0.005)), and knowledge (general) (OR = 1.06, 95% CI = 0.99-1.13 (P = 0.05)).ConclusionThe different pattern of salt intake was observed between men and women. In general, the amount of salt taken by hypertensive patients is higher than recommended allowances. Both men and women add extra amount of salt to food, women when preparing food and men at the table. Salt intake level both during preparing and eating food may be associated with occupation (unemployed), blood pressure level (systolic/diastolic ≥140/90), sex (men), age (54-59), and also patient knowledge (general).

Project description:BackgroundFew studies have investigated the specific effect of single intervention components in randomized controlled trials. The purpose was to investigate the effect of adding group-based diet and exercise counselling to individual life-style counselling on long-term changes in dietary habits.MethodsThe study was a randomized controlled intervention study. From a general Danish population, aged 30 to 60 years (n = 61,301), two random sample were drawn (group A, n = 11,708; group B, n = 1,308). Subjects were invited for a health screening program. Participation rate was 52.5%. All participants received individual life-style counselling. Individuals at high risk of ischemic heart disease in group A were furthermore offered group-based life-style counselling. The intervention was repeated for high-risk individuals after one and three years. At five-year follow-up all participants were invited for a health examination. High risk individuals were included in this study (n = 2 356) and changes in dietary intake were analyzed using multilevel linear regression analyses.ResultsAt one-year follow-up group A had significantly increased the unsaturated/saturated fat ratio compared to group B and in men a significantly greater decrease in saturated fat intake was found in group A compared to group B (net change: -1.13 E%; P = 0.003). No differences were found between group A and B at three-year follow-up. At five-year follow-up group A had significantly increased the unsaturated/saturated fat ratio (net change: 0.09; P = 0.01) and the fish intake compared to group B (net change: 5.4 g/day; P = 0.05). Further, in men a non-significant tendency of a greater decrease was found at five year follow-up in group A compared to group B (net change: -0.68 E%; P = 0.10). The intake of fibre and vegetables increased in both groups, however, no significant difference was found between the groups. No differences between groups were found for saturated fat intake in women.ConclusionOffering group-based counselling in addition to individual counselling resulted in small, but significantly improved dietary habits at five-year follow-up and a tendency of better maintenance, compared to individual counselling alone.Trial registrationThe Inter99 study was approved by the local Ethics Committee (KA 98 155) and is registered with ClinicalTrials.gov (registration number: NCT00289237).

Project description:Sodium intake influences blood pressure and proteinuria, yet the impact on long-term outcomes is uncertain in chronic kidney disease (CKD). Accurate assessment is essential for clinical and public policy recommendations, but few large-scale studies use 24-h urine collections. Recent studies that used spot urine sodium and associated estimating equations suggest that they may provide a suitable alternative, but their accuracy in patients with CKD is unknown.We compared the accuracy of 4 equations [the Nerbass, INTERSALT (International Cooperative Study on Salt, Other Factors, and Blood Pressure), Tanaka, and Kawasaki equations] that use spot urine sodium to estimate 24-h sodium excretion in patients with moderate to advanced CKD.We evaluated the accuracy of spot urine sodium to predict mean 24-h urine sodium excretion over 9 mo in 129 participants with stage 3-4 CKD. Spot morning urine sodium was used in 4 estimating equations. Bias, precision, and accuracy were assessed and compared across each equation.The mean age of the participants was 67 y, 52% were female, and the mean estimated glomerular filtration rate was 31 ± 9 mL · min(-1) · 1.73 m(-2) The mean ± SD number of 24-h urine collections was 3.5 ± 0.8/participant, and the mean 24-h sodium excretion was 168.2 ± 67.5 mmol/d. Although the Tanaka equation demonstrated the least bias (mean: -8.2 mmol/d), all 4 equations had poor precision and accuracy. The INTERSALT equation demonstrated the highest accuracy but derived an estimate only within 30% of mean measured sodium excretion in only 57% of observations. Bland-Altman plots revealed systematic bias with the Nerbass, INTERSALT, and Tanaka equations, underestimating sodium excretion when intake was high.These findings do not support the use of spot urine specimens to estimate dietary sodium intake in patients with CKD and research studies enriched with patients with CKD. The parent data for this study come from a clinical trial that was registered at clinicaltrials.gov as NCT00785629.

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Does pragmatically structured outpatient dietary counselling reduce sodium intake in hypertensive patients? Study protocol for a randomized controlled trial.

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Does pragmatically structured outpatient dietary counselling reduce sodium intake in hypertensive patients? Study protocol for a randomized controlled trial.

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