scholarly journals Effects of a Novel Contextual Just-In-Time Mobile App Intervention (LowSalt4Life) on Sodium Intake in Adults With Hypertension: Pilot Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Michael P Dorsch ◽  
Maria L Cornellier ◽  
Armella D Poggi ◽  
Feriha Bilgen ◽  
Peiyu Chen ◽  
...  

BACKGROUND High dietary sodium intake is a significant public health problem in the United States. High sodium consumption is associated with high blood pressure and high risk of cardiovascular disease. OBJECTIVE The aim of this study was to evaluate the effect of a just-in-time adaptive mobile app intervention, namely, LowSalt4Life, on reducing sodium intake in adults with hypertension. METHODS In this study, 50 participants aged ≥18 years who were under treatment for hypertension were randomized (1:1, stratified by gender) into 2 groups, namely, the App group (LowSalt4Life intervention) and the No App group (usual dietary advice) in a single-center, prospective, open-label randomized controlled trial for 8 weeks. The primary endpoint was the change in the 24-hour urinary sodium excretion estimated from spot urine by using the Kawasaki equation, which was analyzed using unpaired two-sided <i>t</i> tests. Secondary outcomes included the change in the sodium intake measured by the food frequency questionnaire (FFQ), the 24-hour urinary sodium excretion, blood pressure levels, and the self-reported confidence in following a low-sodium diet. RESULTS From baseline to week 8, there was a significant reduction in the Kawasaki-estimated 24-hour urinary sodium excretion calculated from spot urine in the App group compared to that in the No App group (–462 [SD 1220] mg vs 381 [SD 1460] mg, respectively; <i>P</i>=.03). The change in the 24-hour urinary sodium excretion was –637 (SD 1524) mg in the App group and –322 (SD 1485) mg in the No App group (<i>P</i>=.47). The changes in the estimated sodium intake as measured by 24-hour dietary recall and by FFQ in the App group were –1537 (SD 2693) mg and –1553 (SD 1764) mg while those in the No App group were –233 (SD 2150) mg and –515 (SD 1081) mg, respectively (<i>P</i>=.07 and <i>P</i>=.01, respectively). The systolic blood pressure change from baseline to week 8 in the App group was –7.5 mmHg while that in the No App group was –0.7 mmHg (<i>P</i>=.12), but the self-confidence in following a low-sodium diet was not significantly different between the 2 groups. CONCLUSIONS This study shows that a contextual just-in-time mobile app intervention resulted in a greater reduction in the dietary sodium intake in adults with hypertension than that in the control group over a 8-week period, as measured by the estimated 24-hour urinary sodium excretion from spot urine and FFQ. The intervention group did not show a significant difference from the control group in the self-confidence in following a low sodium diet and in the 24-hour urinary sodium excretion or dietary intake of sodium as measured by the 24-hour dietary recall. A larger clinical trial is warranted to further elucidate the effects of the LowSalt4Life intervention on sodium intake and blood pressure levels in adults with hypertension. CLINICALTRIAL ClinicalTrials.gov NCT03099343; https://clinicaltrials.gov/ct2/show/NCT03099343 INTERNATIONAL REGISTERED REPORT RR2-10.2196/11282

10.2196/16696 ◽  
2020 ◽  
Vol 8 (8) ◽  
pp. e16696
Author(s):  
Michael P Dorsch ◽  
Maria L Cornellier ◽  
Armella D Poggi ◽  
Feriha Bilgen ◽  
Peiyu Chen ◽  
...  

Background High dietary sodium intake is a significant public health problem in the United States. High sodium consumption is associated with high blood pressure and high risk of cardiovascular disease. Objective The aim of this study was to evaluate the effect of a just-in-time adaptive mobile app intervention, namely, LowSalt4Life, on reducing sodium intake in adults with hypertension. Methods In this study, 50 participants aged ≥18 years who were under treatment for hypertension were randomized (1:1, stratified by gender) into 2 groups, namely, the App group (LowSalt4Life intervention) and the No App group (usual dietary advice) in a single-center, prospective, open-label randomized controlled trial for 8 weeks. The primary endpoint was the change in the 24-hour urinary sodium excretion estimated from spot urine by using the Kawasaki equation, which was analyzed using unpaired two-sided t tests. Secondary outcomes included the change in the sodium intake measured by the food frequency questionnaire (FFQ), the 24-hour urinary sodium excretion, blood pressure levels, and the self-reported confidence in following a low-sodium diet. Results From baseline to week 8, there was a significant reduction in the Kawasaki-estimated 24-hour urinary sodium excretion calculated from spot urine in the App group compared to that in the No App group (–462 [SD 1220] mg vs 381 [SD 1460] mg, respectively; P=.03). The change in the 24-hour urinary sodium excretion was –637 (SD 1524) mg in the App group and –322 (SD 1485) mg in the No App group (P=.47). The changes in the estimated sodium intake as measured by 24-hour dietary recall and by FFQ in the App group were –1537 (SD 2693) mg and –1553 (SD 1764) mg while those in the No App group were –233 (SD 2150) mg and –515 (SD 1081) mg, respectively (P=.07 and P=.01, respectively). The systolic blood pressure change from baseline to week 8 in the App group was –7.5 mmHg while that in the No App group was –0.7 mmHg (P=.12), but the self-confidence in following a low-sodium diet was not significantly different between the 2 groups. Conclusions This study shows that a contextual just-in-time mobile app intervention resulted in a greater reduction in the dietary sodium intake in adults with hypertension than that in the control group over a 8-week period, as measured by the estimated 24-hour urinary sodium excretion from spot urine and FFQ. The intervention group did not show a significant difference from the control group in the self-confidence in following a low sodium diet and in the 24-hour urinary sodium excretion or dietary intake of sodium as measured by the 24-hour dietary recall. A larger clinical trial is warranted to further elucidate the effects of the LowSalt4Life intervention on sodium intake and blood pressure levels in adults with hypertension. Trial Registration ClinicalTrials.gov NCT03099343; https://clinicaltrials.gov/ct2/show/NCT03099343 International Registered Report Identifier (IRRID) RR2-10.2196/11282


2018 ◽  
Author(s):  
Michael P Dorsch ◽  
Lawrence C An ◽  
Scott L Hummel

BACKGROUND High sodium intake is a significant public health problem in the United States. Interventions that lower sodium intake can decrease blood pressure and improve cardiovascular outcomes. Restaurants and grocery stores are prime targets for intervention with about 77% of all sodium intake in the average US diet coming from processed and restaurant foods. OBJECTIVE This study proposes that a mobile app intervention that promotes low-sodium alternatives at grocery stores and restaurants will reduce dietary intake of sodium and improve confidence following a low-sodium diet in hypertension. METHODS In this single-center, prospective, open-label study, patients will be randomized to a mobile app or usual care for 8 weeks. We will randomize 50 patients (age>18 years) diagnosed with hypertension and on antihypertensive therapy for at least 3 months in a 1:1 manner stratified by gender. Study subjects will receive the mobile app, LowSalt4Life, or usual dietary advice for 8 weeks. LowSalt4Life provides a multifaceted intervention based on just-in-time contextual tailored messages at grocery stores and restaurants. The primary endpoint is the change in the estimated 24-hour urinary excretion of sodium from spot urine. Secondary outcomes include change in the sodium content of the food frequency questionnaire, confidence in following a low-sodium diet, urine chloride and creatinine dipsticks, and blood pressure. RESULTS The project was funded in May 2016 until April 2018. This trial is currently enrolling patients. To date, 26 of the 50 patients needed have been enrolled. Results will be available in the Spring of 2019. CONCLUSIONS This randomized controlled trial will test the efficacy of just-in-time contextual tailored messages through a novel mobile app 8-week intervention on urinary sodium excretion in patients with hypertension. We will address a critical evidence gap in the care of patients with hypertension. If effective, this intervention could be scaled to assess effects on blood pressure and cardiovascular events in hypertension. CLINICALTRIAL ClinicalTrials.gov NCT03099343; https://clinicaltrials.gov/ct2/show/NCT03099343 (Archived by WebCite at http://www.webcitation.org/735HNzKlQ) INTERNATIONAL REGISTERED REPOR PRR1-10.2196/11282


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Xiaofu Du ◽  
Le Fang ◽  
Jianwei Xu ◽  
Xiangyu Chen ◽  
Yamin Bai ◽  
...  

AbstractThe direction and magnitude of the association between sodium and potassium excretion and blood pressure (BP) may differ depending on the characteristics of the study participant or the intake assessment method. Our objective was to assess the relationship between BP, hypertension and 24-h urinary sodium and potassium excretion among Chinese adults. A total of 1424 provincially representative Chinese residents aged 18 to 69 years participated in a cross-sectional survey in 2017 that included demographic data, physical measurements and 24-h urine collection. In this study, the average 24-h urinary sodium and potassium excretion and sodium-to-potassium ratio were 3811.4 mg/day, 1449.3 mg/day, and 4.9, respectively. After multivariable adjustment, each 1000 mg difference in 24-h urinary sodium excretion was significantly associated with systolic BP (0.64 mm Hg; 95% confidence interval [CI] 0.05–1.24) and diastolic BP (0.45 mm Hg; 95% CI 0.08–0.81), and each 1000 mg difference in 24-h urinary potassium excretion was inversely associated with systolic BP (− 3.07 mm Hg; 95% CI − 4.57 to − 1.57) and diastolic BP (− 0.94 mm Hg; 95% CI − 1.87 to − 0.02). The sodium-to-potassium ratio was significantly associated with systolic BP (0.78 mm Hg; 95% CI 0.42–1.13) and diastolic BP (0.31 mm Hg; 95% CI 0.10–0.53) per 1-unit increase. These associations were mainly driven by the hypertensive group. Those with a sodium intake above about 4900 mg/24 h or with a potassium intake below about 1000 mg/24 h had a higher risk of hypertension. At higher but not lower levels of 24-h urinary sodium excretion, potassium can better blunt the sodium-BP relationship. The adjusted odds ratios (ORs) of hypertension in the highest quartile compared with the lowest quartile of excretion were 0.54 (95% CI 0.35–0.84) for potassium and 1.71 (95% CI 1.16–2.51) for the sodium-to-potassium ratio, while the corresponding OR for sodium was not significant (OR, 1.28; 95% CI 0.83–1.98). Our results showed that the sodium intake was significantly associated with BP among hypertensive patients and the inverse association between potassium intake and BP was stronger and involved a larger fraction of the population, especially those with a potassium intake below 1000 mg/24 h should probably increase their potassium intake.


2019 ◽  
Vol 32 (10) ◽  
pp. 983-991
Author(s):  
Elizabeth R Wan ◽  
Jennifer Cross ◽  
Reecha Sofat ◽  
Stephen B Walsh

Abstract BACKGROUND Sodium intake is correlated with the development of hypertension. Guyton’s principals suggest that the 24-hour urinary sodium excretion reflects sodium ingestion over the same period. 24-hour urine collections are arduous to collect, so many centers use spot urinary measurements instead. We compared spot to matched 24-hour urinary electrolyte measurements. METHODS We examined 419 hypertensive patients from the UCL Complex Hypertension Clinic. 77 had matched and complete 24-hour and spot urinary and serum biochemistry to examine. We compared the spot and 24-hour urinary; sodium concentration, Na/Cr ratio, FENa, Kawasaki and Tanaka estimated sodium excretion as well as the potassium concentration, K/Cr ratio, Kawasaki and Tanaka potassium excretion. RESULTS Our cohort was 58% male and the median age was 41 years. The 24-hour and spot Na concentrations correlated moderately (r = 0.4633, P < 0.0001). The 24-hour and spot Na/creatinine ratios correlated weakly (r = 0.2625, P = 0.0194). The 24-hour and spot FENa results showed a weak negative correlation (r = −0.222, P = ns). The 24-hour sodium excretion and the Kawasaki-derived spot urine sodium excretion correlated moderately (r = 0.3118, P = 0.0052). All Bland–Altman analyses showed poor agreement. The 24-hour and spot potassium concentrations correlated very poorly (r = 0.1158, P = ns). The 24-hour and spot urinary K/creatinine ratios correlated weakly (r = 0.47, P ≤ 0.0001). 24-hour and Kawasaki and Tanaka estimated potassium excretions correlated much better (r = 0.58, P < 0.0001). CONCLUSIONS Spot urinary measurements of sodium give a very poor understanding of the natriuresis occurring over the same 24-hour period. The Kawasaki and Tanaka estimations of the 24-hour sodium excretion showed a much lower correlation than previously reported.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Carter ◽  
F Re ◽  
I Hammami ◽  
T Littlejohns ◽  
M Arnold ◽  
...  

Abstract Background Randomised control trials have demonstrated direct positive and causal associations of 24-hr measurements of urinary sodium excretion on blood pressure. However, prospective studies, which often used spot (not 24-hr) measurements of urinary sodium, have reported J-shaped associations with higher risks of cardiovascular disease (CVD) at sodium intake &lt;4 g/day. The reasons for the discrepant results are not fully understood, but have prompted some to question the World Health Organisation's recommendations to restrict sodium intake to &lt;2.3g/day. Purpose We examined the effects of within-person variability in spot urinary sodium (UNa) measurements on immediate and delayed associations of UNa with blood pressure at baseline and at resurvey, and with incident cardiovascular disease in the UK Biobank (UKB). Methods Baseline spot urine samples were measured in 502,619 adults at baseline and in 20,346 participants who were resurveyed at 4 years after baseline. Linear regression was used to assess associations of baseline UNa measurements with systolic blood pressure (SBP; mmHg) at baseline and at resurvey. Cox regression was used estimate the associations between baseline measures of UNa with incident CVD events (recorded from linkage with hospital records). All analyses were adjusted for confounders and corrected for regression dilution bias. Results After excluding participants with prevalent diseases, the primary analyses involved 386,060 adults who were followed-up for a median of 7.8 years, during which ∼13,000 CVD events occurred. Estimated mean (SD) urinary sodium excretion was 77.4 mmol/L (SD 44.4, IQR = 42.8–103.7 mmol/L), and mean SBP/DBP were 137.5/82.3 (SD 18.5/10.1) mmHg, respectively. Within-person variability in UNa was high, with a self-correlation of 0.35 at 4 years between measurements. After adjustment for confounders and correction for regression dilution bias, a 100 mmol/L higher UNa was associated with an immediate 3.2 mmHg higher SBP (95% confidence interval [CI]: 2.8–3.6) in cross-sectional analyses (Figure 1). However, the corresponding associations of baseline UNa with SBP at resurvey was completely attenuated (p=0.20). The predicted risk of CVD was 1.06 (95% CI 1.06–1.07, p&lt;0.001) for a 3.2 mmHg higher SBP, but the observed risk for a 100 mmol/L higher UNa was 0.95 (95% CI 0.82–1.10, p=0.47) (Figure 1). Conclusions While spot measurements of UNa were strongly associated with immediate effects on SBP, the magnitude of within-person variability in UNa precluded detection of associations with SBP several years after baseline or with risk of CVD. The extreme within-person variability in spot UNa may explain the discrepant results of the trials and observational studies of sodium and blood pressure. Figure 1. Spot UNa with SBP and CVD in UK Biobank Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): Core funding from the Medical Research Council-Population Health Research Unit, British Heart Foundation


Author(s):  
Abu Mohd Naser ◽  
Feng J. He ◽  
Mahbubur Rahman ◽  
Norm R.C. Campbell

We evaluated the relationship between estimated 24-hour urinary sodium excretion from the Kawasaki, Tanaka, and INTERSALT (International Study of Sodium, Potassium, and Blood Pressure) formulas and blood pressure (BP). We pooled 10 034 person-visit data from 3 cohort studies in Bangladesh that had measured 24-hour urine sodium (m-24hUNa), potassium, creatinine excretion, and BP. We used m-24hUNa, potassium, and creatinine where necessary, rather than spot urine values in the formulas. Bland-Altman plots were used to determine the bias associated with formula-estimated sodium relative to m-24hUNa. We compared the sodium excretion and BP relationships from m-24hUNa versus formula-estimated sodium excretions, using restricted cubic spline plots for adjusted multilevel linear models. All formulas overestimated 24-hour sodium at lower levels but underestimated 24-hour sodium at higher levels. There was a linear relationship between m-24hUNa excretion and systolic BP, while estimated sodium excretion from all 3 formulas had a J-shaped relationship with systolic BP. The relationships between urine sodium excretion and diastolic BP were more complex but were also altered by using formulas. All formulas had associations with BP when a sex-specific constant sodium concentration was inserted in place of measured sodium. Since we used the m-24hUNa, potassium, and creatinine concentrations in formulas, the J-shaped relationships are due to intrinsic problems in the formulas, not due to spot urine sampling. Formula-estimated 24-hour urine sodium excretion should not be used to examine the relationship between sodium excretion and BP since they alter the real associations.


Circulation ◽  
2012 ◽  
Vol 125 (suppl_10) ◽  
Author(s):  
Ulla Toft ◽  
Charlotte Cerquira ◽  
Torben Jørgensen

Background: Tanaka et al (J Hum Hypert 2002; 16: 97-103) developed a simple method to estimate populational 24-h urinary sodium excretion using a casual urine specimen. However, this method was developed and validated in a Japanese population and thus this method might not be valid in populations that differ markedly from this population. Hypothesis: We assessed the hypothesis that the 24 hour urinary sodium excretion can be estimated from a casual spot urine using the Tanaka prediction method in a Danish general population. Methods: Overall 473 Danish individuals provided both a 24h urine collection and a spot urine sample. Data were collected in the Danthyr study (248 women aged 25-30 years and 60-65 years) and the Inter99 study (102 men and 113 women aged 30-60 years), respectively. Only participants with complete 24h urine collection (validated by the PABA method) were included. We compared the estimated daily sodium excretion through 24h urine (the gold standard) with the predicted 24 h sodium excretion from a causal urine specimen, using the Tanaka prediction method. Results: The predicted median 24 h sodium excretion (median [5 and 95 percentile]) was 8.6 gram [3.7;17.5] compared with a median measured 24 h sodium excretion of 8.9 [5.4; 13:1]. The mean (sd) residual (measured minus predicted 24 h sodium excretion) was 0.08 (3.7). The correlation (Spearman) between predicted and measured 24 h sodium excretion was 0.39 and the R 2 was 0.17. The proportion of individuals classified in the same or adjacent quintiles was 67%. Gross misclassification was found for 3% of the individuals. However, a Bland-Altman plot indicated a tendency of underestimation the sodium excretion for individuals with a high level of sodium excretion (>14 g per day). Conclusion: The Tanaka prediction model gives a reasonable estimate of sodium intake in a Danish population using casual spot urines. However, the validation study showed a tendency of underestimation of the sodium intake for individuals with a high sodium excretion (>14 g per day).


2021 ◽  
Vol 319 ◽  
pp. 01066
Author(s):  
Mohamed Idrissi ◽  
Naima Saeid ◽  
Anass Rami ◽  
Mohammed El Mzibri ◽  
Arthur Assako ◽  
...  

Background: Excessive sodium intake is linked to high blood pressure. Estimating sodium intake is difficult. The 24-h urine collection is currently the recommended method for estimating intake but cumbersome for large population studies. Predictive model to estimate sodium intake based on single spot urine were developed, but showed inconsistency when used in extern populations. This study aims to develop a specific model for estimating sodium excretion over 24 hours for the Moroccan population. Methods: 371 participants in the urinary validation sub-study of the STEP-wise survey-Morocco 2017-2018 provided a valid 24-hour urine collection and spot urine specimens. Participant were randomly assigned to the training (n=183) and the validation data set (n=188). Results: A prediction model for 24-hour sodium excretion was developed. Adjusted R2 was 0.258. In the validation data set, correlation was 0.431 [95%CI; 0.258-0.580], and the adjusted R2 was 0.190. The Bland-Altman plot showed a nonsignificant small mean bias of -18 mg (95%CI, -213 to 177) in predicting 24-h urinary sodium excretion at the group level. At the individual level, limits of agreement were wide. Conclusion: This new model developed from a single spot urine could be used to predict the average 24-h sodium excretion of Moroccan adults.


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