scholarly journals A Novel Just-in-Time Contextual Mobile App Intervention to Reduce Sodium Intake in Hypertension: Protocol and Rationale for a Randomized Controlled Trial (LowSalt4Life Trial) (Preprint)

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

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


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


1984 ◽  
Vol 66 (3) ◽  
pp. 269-276 ◽  
Author(s):  
M. H. De Keijzer ◽  
A. P. Provoost ◽  
E. D. Wolff ◽  
W. J. Kort ◽  
I. M. Weijma ◽  
...  

1. In an experimental model of post-renal transplantation hypertension in rats, we studied the effect of a reduction of sodium intake on the development of this type of hypertension. 2. Systolic blood pressure, plasma- renin concentration and renal function were measured regularly in recipients of an allogeneic kidney transplant that had previously undergone active immunological enhancement. 3. Transplant recipients on a normal diet showed a rise in systolic blood pressure during the second week after transplantation. The systolic blood pressure of recipients on a low sodium diet remained normotensive throughout the 15 weeks follow-up period. 4. The plasma renin concentration was low in the hypertensive recipients on a normal diet, as compared with unilaterally nephrectomized controls. Although the plasma renin concentration of recipients on a low sodium diet fell below that of unilaterally nephrectomized controls on a low sodium diet, it was higher than that of recipients on a normal diet. 5. The renal function of transplant recipients was greatly reduced compared with that of control rats. The glomerular filtration rate was reduced to a greater extent than the effective renal plasma flow. 6. In a separate experiment it was revealed that a similar reduction in the glomerular filtration rate of kidneys permanently damaged by temporary ischaemia did not result in an increase in the systolic blood pressure. 7. Survival up to 6 weeks after transplantation was the same for both groups of recipients. Recipients on a low sodium diet, however, showed a better 15 weeks survival, probably owing to the absence of hypertension in this group. 8. The prevention of the development of hypertension by means of a reduction of sodium intake, points to an involvement of sodium retention in this post-transplantation hypertension model.


2021 ◽  
Vol 44 (1) ◽  
pp. 109-120
Author(s):  
Agustina Pungki Astuti ◽  
Didit Damayanti ◽  
Iskari Ngadiarti

The low sodium and Diet Approaches to Stop Hypertension (DASH) are diets for reducing high blood pressure. This study aimed to analyze the effect of nutrition counseling on the DASH diet compared to low sodium diet on blood pressure in hypertensive patients. The study design was an experimental study that randomly allocated 34 respondents to DASH diet and 35 respondents to low sodium diet. The ages of respondents were 43 to 76 years and women were 74.3 percent. Nutrition counseling was conducted by researchers to respondents who visited health center or Posbindu Larangan Utara. Nutritional counseling was conducted for an average of 20 minutes using existing brochures. Low sodium diet emphasizes reducing sodium intake while DASH diet emphasis more on consuming lots of vegetables, fruit, nuts and low-fat products. Variables collected were the characteristics of respondent, disease, drugs taken and nutritional status, while blood pressure using a sphygmomanometer, food intake including sodium were measured before and 2 weeks after nutritional counseling. Results showed that there was a significant difference in diastolic blood pressure after patients were given DASH diet compared to low sodium diet (p 0.05) and there was a significant difference in delta of systolic and diastolic reduction in DASH diet compared to low sodium diet. Test also showed a significant reduction in systolic, diastolic blood pressure and sodium intake (p 0.001) in both diet groups after receiving counseling. It concluded that DASH diet can be recommended to decrease blood pressure in hypertensive patients with consider nutritional status. ABSTRAK  Diet Rendah Garam (RG) dan Diet Approaches to Stop Hypertension (DASH) adalah diet untuk menurunkan tekanan darah tinggi. Penelitian ini bertujuan untuk menganalisa pengaruh konseling gizi diet DASH dibandingkan diet RG terhadap tekanan darah pasien hipertensi. Rancangan penelitian adalah eksperimen yang secara acak mengalokasi diet DASH kepada 34 orang dan diet RG kepada 35 orang responden. Usia responden antara 43 hingga 76 tahun dan sebagian besar perempuan (74,3%). Konseling gizi dilakukan oleh tim peneliti kepada pasien hipertensi yang memeriksakan diri ke puskesmas atau posbindu Larangan Utara. Konseling gizi dilakukan rata-rata 20 menit menggunakan brosur yang sudah ada. Diet RG menekankan pengurangan asupan natrium sedangkan diet DASH lebih menekankan ke banyak konsumsi sayur, buah, kacang-kacangan dan produk rendah lemak. Variabel yang dikumpulkan adalah karakteristik responden, penyakit dan obat yang diminum serta status gizi sedangkan tekanan darah menggunakan sfigmomanometer, asupan makanan, zat gizi termasuk natrium diukur sebelum dan 2 minggu setelah konseling gizi dilakukan. Hasil menunjukkan adanya perbedaan yang bermakna pada tekanan darah diastolik setelah pasien diberi diet DASH dibandingkan dengan pasien yang diberi diet RG (p0,05) dan terdapat perbedaan delta penurunan sistolik dan diastolik bermakna pada diet DASH dibanding diet RG. Analisa juga menunjukkan adanya penurunan tekanan darah sistolik, diastolik dan asupan natrium  yang bermakna (p0.001) pada kedua kelompok diet setelah mendapat konseling diet DASH dan diet RG. Disimpulkan diet DASH dapat direkomendasikan untuk membantu menurunkan tekanan darah pada pasien hipertensi dengan memperhatikan status gizi. Kata kunci: hipertensi, tekanan darah, diet rendah garam, diet DASH


2019 ◽  
Author(s):  
Su Lin Lim ◽  
Jolyn Johal ◽  
Kai Wen Ong ◽  
Chad Yixian Han ◽  
Yiong Huak Chan ◽  
...  

BACKGROUND The prevalence of nonalcoholic fatty liver disease (NAFLD) reaches up to 30% in the Asian adult population, with a higher prevalence in obese patients. Weight reduction is typically recommended for patients at high risk or diagnosed with NAFLD, but is a challenge to achieve. OBJECTIVE We aimed to evaluate the effect of a lifestyle intervention with a mobile app on weight loss in NAFLD patients. METHODS This prospective randomized controlled trial included 108 adults with NAFLD confirmed by steatosis on ultrasound and a body mass index ≥23 kg/m<sup>2</sup> who were recruited from a fatty liver outpatient clinic. The patients were randomly allocated to either a control group (n=53) receiving standard care, consisting of dietary and lifestyle advice by a trained nurse, or an intervention group (n=55) utilizing the Nutritionist Buddy (nBuddy) mobile app in addition to receiving dietary and lifestyle advice by a dietitian. Body weight, alanine aminotransferase (ALT), aspartate aminotransferase (AST), waist circumference, and blood pressure were measured at baseline, and then at 3 and 6 months. Intention-to-treat and per-protocol analyses were used for statistical comparisons. RESULTS The intervention group had a 5-fold higher likelihood (relative risk 5.2, <i>P</i>=.003, 95% CI 1.8-15.4) of achieving ≥5% weight loss compared to the control group at 6 months. The intervention group also showed greater reductions in weight (mean 3.2, SD 4.1 kg vs mean 0.5, SD 2.9 kg; <i>P</i>&lt;.001), waist circumference (mean 2.9, SD 5.0 cm vs mean –0.7, SD 4.4 cm; <i>P</i>&lt;.001), systolic blood pressure (mean 12.4, SD 14.8 mmHg vs mean 2.4, SD 12.4 mmHg; <i>P</i>=.003), diastolic blood pressure (mean 6.8, SD 8.9 mmHg vs mean –0.9, SD 10.0 mmHg; <i>P</i>=.001), ALT (mean 33.5, SD 40.4 IU/L vs mean 11.5, SD 35.2 IU/L; <i>P</i>=.004), and AST (mean 17.4, SD 27.5 U/L vs mean 7.4, SD 17.6 IU/L, <i>P</i>=.03) at 6 months. CONCLUSIONS Lifestyle intervention enabled by a mobile app can be effective in improving anthropometric indices and liver enzymes in patients with NAFLD. This treatment modality has the potential to be extended to a larger population scale. CLINICALTRIAL Australian New Zealand Clinical Trials Registry ACTRN12617001001381; https://tinyurl.com/w9xnfmp


2018 ◽  
Author(s):  
Lorraine R Buis ◽  
Katee Dawood ◽  
Reema Kadri ◽  
Rachelle Dawood ◽  
Caroline R Richardson ◽  
...  

BACKGROUND African Americans shoulder significant disparities related to hypertension (HTN), which is a serious public health problem in the city of Detroit, Michigan, where more than 80% of the population is African American. Connectivity through smartphones, use of home blood pressure (BP) monitoring, and newly developed mobile health (mHealth) interventions can facilitate behavioral changes and may improve long-term self-care for chronic conditions, but implementation of a combined approach utilizing these methods has not been tested among African American patients with uncontrolled HTN. Since African Americans are more likely than other racial or ethnic subgroups to utilize the emergency department (ED) for ambulatory care, this presents an opportunity to intervene on a population that is otherwise difficult to reach. OBJECTIVE The MI-BP app aims to reduce health disparities related to HTN in the community by employing a user-centered intervention focused on self-BP monitoring, physical activity, reduced sodium intake, and medication adherence. We seek to test the efficacy of MI-BP, an mHealth app for HTN self-management, on BP control (primary aim), physical activity, sodium intake, and medication adherence (secondary aim) in African Americans with HTN. This study also seeks to evaluate the cost-effectiveness of MI-BP when compared with usual care methods. METHODS This is a 1-year randomized controlled trial that will recruit individuals who have uncontrolled HTN from 2 EDs in the city of Detroit, with a planned sample size of 396 randomized participants. To be eligible for inclusion, potential participants must be African American, 25 to 70 years old, previously diagnosed with HTN, have a smartphone compatible with MI-BP, and have uncontrolled BP at triage and on repeat measurement at least 1-hour post triage vitals. Once a participant is deemed eligible, all study procedures and subsequent follow-up visits (8 in total) are conducted at the Wayne State University Clinical Research Service Center. We seek to determine the effect of MI-BP on BP for 1 year (using BP control and mean systolic BP as coprimary outcomes and physical activity, sodium intake, and medication adherence as secondary outcomes) compared with usual care controls. RESULTS Recruitment for this study began in January 2018. The study will continue through 2021. CONCLUSIONS As the first of its kind conducted in an ED setting, MI-BP was designed to document the efficacy and acceptability of a multicomponent mHealth approach to help African Americans with uncontrolled BP modify their lifestyle to better manage their HTN. We expect to lay the foundation to sustainably reduce HTN-related health disparities through better integration of multiple behavior self-monitoring and improve outcomes for those who traditionally rely on the ED for chronic disease care. CLINICALTRIAL ClinicalTrials.gov NCT02360293; http://clinicaltrials.gov/ct2/show/NCT02360293 INTERNATIONAL REGISTERED REPOR RR1-10.2196/12601


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