Impact of self-monitoring of salt intake by salt meter in hypertensive patients: A randomized controlled trial (SMAL-SALT).
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ABSTRACT:
SUBMITTER: Wiriyatanakorn S
PROVIDER: S-EPMC8678669 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:(1) Background: Excessive salt consumption is associated with an increased risk of hypertension and cardiovascular disease, and it is essential to reduce it to the level recommended by the World Health Organization (<5 g/day). The main objective of this study is to verify the impact of an intervention, which used the Salt Control H equipment to reducing salt consumption; (2) Methods: The study was an 8-week randomized control trial with 114 workers from a public university. The intervention group (n = 57) used the equipment to monitor and control the use of salt during cooking (Salt Control H) at home for 8 weeks. The primary outcome was 24 h urinary sodium excretion as a proxy of salt intake. Secondary outcomes included changes in 24 h urinary potassium excretion, sodium to potassium ratio (Na:K), and blood pressure. (3) Results: There was a decrease in sodium intake after the intervention but with no statistical significance. When analyzing the results by sex and hypertension status, there was a reduction in sodium (-1009 (-1876 to -142), p = 0.025) and in Na:K ratio (-0.9 (-1.5 to -0.3), p = 0.007) in hypertensive men in the intervention group. (4) Conclusions: Interventions with dosage equipment can be valid approaches in individual salt reduction strategies, especially in hypertensive men.
| S-EPMC8746390 | biostudies-literature
Project description:Salt intake is one of the most important environmental factors impacting hypertension onset. Meanwhile, the potential roles of the gut microbiome (GM) in altering the health status of hosts have drawn considerable attention. Here, we aimed to perform an observational study to investigate the impact of intestinal bacterial flora in hypertensive patients with low-salt or high-salt intake. A total of 239 participants were enrolled, and their gut microbiomes, clinical and demographic details, as well as physiological parameters pertaining to the renin-angiotensin-aldosterone system and inflammatory cytokine profiles, were examined. The participants were classified into four groups based on the presence of different enterotype bacteria, as determined via cluster analysis, and salt intake: low salt/GM enterotype 1, low salt/GM enterotype 2, high salt/GM enterotype 1, and high salt/GM enterotype 2. Results show that the prevalence of hypertension was significantly lower in the low-salt/GM enterotype 2 group (27%) compared to the low salt/GM enterotype 1 group (47%; p = 0.04). Alternatively, no significant differences were observed in hypertension prevalence between the two high-salt intake groups (GM enterotype 1 = 50%, GM enterotype 2 = 47%; p = 0.83). Furthermore, The low-salt/GM enterotype 2 was higher in the relative abundances of Blautia, Bifidobacterium, Escherichia-Shigella, Lachnoclostridium, and Clostridium sensu stricto than the low-salt/GM enterotype 1. differed significantly between the GM enterotypes. These results suggested that consumption of a low-salt diet was ineffective in regulating hypertension in individuals with a specific gut bacteria composition. Our findings support the restoration of GM homeostasis as a new strategy for controlling blood pressure and preventing the development of hypertension.
| S-EPMC7492604 | biostudies-literature
Project description:ObjectiveThis pilot study tested counselor access to participants' digital self-monitoring (SM) data as a means of improving long-term lifestyle modification (LM) outcomes.MethodsAfter 12 weeks of weight-loss treatment, participants (N = 77) were randomized to LM or LM+SHARE for weeks 13 to 52. All participants received monthly phone calls and weekly text messages from weeks 13 to 52 and were instructed to engage in daily digital SM of weight, eating, and exercise. In LM+SHARE, but not LM, counselors had access to SM device data. Assessments were conducted as weeks 0, 13, 26, and 52.ResultsRetention, engagement, and treatment satisfaction were excellent. LM+SHARE participants, compared with LM, had more frequent SM of weight and eating. Weight loss continued at a similar rate in both conditions from weeks 13 to 26. From weeks 26 to 52, those in LM regained approximately 2 kg, whereas those in LM+SHARE maintained weight loss, a significant difference. Nonetheless, total weight loss did not significantly differ by condition. Engagement in dietary SM mediated the effect of condition on weight.ConclusionsCounselor access to SM data is feasible and acceptable. Additional research is warranted to determine whether it can meaningfully improve outcomes.
| S-EPMC8628117 | biostudies-literature
Project description:We determined whether a town-level comprehensive intervention program could lower the salt intake of a population. The parallel, cluster randomized controlled trial was carried out between October 2018 and January 2020 in 48 towns from 12 counties across 6 provinces in China. All participants were asked to complete the 24 h urine collections, anthropometric measurements and questionnaires at the baseline and one-year post-intervention survey. A total of 2693 participants aged 18 to 75 years were recruited at the baseline. A total of 1347 individuals in 24 towns were allocated to the intervention group and the others were allocated to the control group. Valid information from 2335 respondents was collected in the follow-up survey. The 24-h urinary sodium excretion was 189.7 mmol/24 h for the intervention group and 196.1 mmol/24 h for the control group at baseline. At a one-year follow-up, the mean effect of salt intake did not show a significant change (p = 0.31) in the intervention group compared to the control group. However, the mean result of potassium excretion in the intervention group increased by 2.18 mmol/24 h (85.03 mg/24 h) (p = 0.004) and systolic blood pressure decreased by 2.95 mmHg (p < 0.001). The salt-related knowledge and attitude toward salt reduction improved significantly in the intervention group (p < 0.05). A longer period of intervention and follow-up assessment might be needed to evaluate the long-term effectiveness of the program on salt reduction.
| S-EPMC9654622 | biostudies-literature
Project description:ObjectiveTo examine whether the self-monitoring interventions of a mobile health app reduce sedentary behavior in the short and long terms.MethodWe designed a double-blind randomized control trial. Participants were selected from among the staff of a medical institution and registrants of an online research firm. Forty-nine participants were randomly assigned to either a control group (n = 25) or an intervention group (n = 24). The control group was given only the latest information about sedentary behavior, and the intervention was provided real-time feedback for self-monitoring in addition to the information. These interventions provided for 5 weeks (to measure the short-term effect) and 13 weeks (to measure the long-term effect) via the smartphone app. Measurements were as follows: subjective total sedentary time (SST), objective total sedentary time (OST), mean sedentary bout duration (MSB), and the number of sedentary breaks (SB). Only SST was measured by self-report based on the standardized International Physical Activity Questionnaire and others were measured with the smartphone.ResultsNo significant results were observed in the short term. In the long term, while no significant results were also observed in objective sedentary behavior (OST, MSB, SB), the significant differences were observed in subjective sedentary behavior (SST, βint - βctrl between baseline and 9/13 weeks; 1.73 and 1.50 h/d, respectively).ConclusionsReal-time feedback for self-monitoring with smartphone did not significantly affect objective sedentary behavior. However, providing only information about sedentary behavior to users with smartphones may make misperception on the amount of their subjective sedentary behavior.
| S-EPMC7448798 | biostudies-literature
Project description:BACKGROUND:Self-monitoring of dietary intake is a valuable component of behavioral weight loss treatment; however, it declines quickly, thereby resulting in suboptimal treatment outcomes. OBJECTIVE:This study aimed to examine a novel behavioral weight loss intervention that aims to attenuate the decline in dietary self-monitoring engagement. METHODS:GoalTracker was an automated randomized controlled trial. Participants were adults with overweight or obesity (n=105; aged 21-65 years; body mass index, BMI, 25-45 kg/m2) and were randomized to a 12-week stand-alone weight loss intervention using the MyFitnessPal smartphone app for daily self-monitoring of either (1) both weight and diet, with weekly lessons, action plans, and feedback (Simultaneous); (2) weight through week 4, then added diet, with the same behavioral components (Sequential); or (3) only diet (App-Only). All groups received a goal to lose 5% of initial weight by 12 weeks, a tailored calorie goal, and automated in-app reminders. Participants were recruited via online and offline methods. Weight was collected in-person at baseline, 1 month, and 3 months using calibrated scales and via self-report at 6 months. We retrieved objective self-monitoring engagement data from MyFitnessPal using an application programming interface. Engagement was defined as the number of days per week in which tracking occurred, with diet entries counted if ?800 kcal per day. Other assessment data were collected in-person via online self-report questionnaires. RESULTS:At baseline, participants (84/100 female) had a mean age (SD) of 42.7 (11.7) years and a BMI of 31.9 (SD 4.5) kg/m2. One-third (33/100) were from racial or ethnic minority groups. During the trial, 5 participants became ineligible. Of the remaining 100 participants, 84% (84/100) and 76% (76/100) completed the 1-month and 3-month visits, respectively. In intent-to-treat analyses, there was no difference in weight change at 3 months between the Sequential arm (mean -2.7 kg, 95% CI -3.9 to -1.5) and either the App-Only arm (-2.4 kg, -3.7 to -1.2; P=.78) or the Simultaneous arm (-2.8 kg, -4.0 to -1.5; P=.72). The median number of days of self-monitoring diet per week was 1.9 (interquartile range [IQR] 0.3-5.5) in Sequential (once began), 5.3 (IQR 1.8-6.7) in Simultaneous, and 2.9 (IQR 1.2-5.2) in App-Only. Weight was tracked 4.8 (IQR 1.9-6.3) days per week in Sequential and 5.1 (IQR 1.8-6.3) days per week in Simultaneous. Engagement in neither diet nor weight tracking differed between arms. CONCLUSIONS:Regardless of the order in which diet is tracked, using tailored goals and a commercial mobile app can produce clinically significant weight loss. Stand-alone digital health treatments may be a viable option for those looking for a lower intensity approach. TRIAL REGISTRATION:ClinicalTrials.gov NCT03254953; https://clinicaltrials.gov/ct2/show/NCT03254953 (Archived by WebCite at http://www.webcitation.org/72PyQrFjn).
| S-EPMC6416539 | biostudies-literature
Project description:BACKGROUND:Observational data from the retrospective, non-randomized Pregnancy REmote MOnitoring I (PREMOM I) study showed that remote monitoring (RM) may be beneficial for prenatal observation of women at risk for gestational hypertensive disorders (GHD) in terms of clinical outcomes, health economics, and stakeholder perceptions. PREMOM II is a prospective, randomized, multicenter follow-up study that was performed to explore these promising results. METHODS:After providing written consent, 3922 pregnant women aged ?18?years who are at increased risk of developing GHD will be randomized (1:1:1 ratio) to (a) conventional care (control group), (b) a patient self-monitoring group, and (c) a midwife-assisted RM group. The women in each group will be further divided (1:1 ratio) to evaluate the outcomes of targeted or non-targeted (conventional) antihypertensive medication. Women will be recruited in five hospitals in Flanders, Belgium: Ziekenhuis Oost-Limburg, Universitaire Ziekenhuis Antwerpen, Universitaire Ziekenhuis Leuven, AZ Sint Jan Brugge-Oostende, and AZ Sint Lucas Brugge. The primary outcomes are: (1) numbers and types of prenatal visits; (2) maternal outcomes; (3) neonatal outcomes; (4) the applicability and performance of RM; and (5) compliance with RM and self-monitoring. The secondary outcomes are: (1) cost-effectiveness and willingness to pay; (2) patient-reported outcome measures (PROMS) questionnaires on the experiences of the participants; and (3) the maternal and perinatal outcomes according to the type of antihypertensive medication. Demographic, and maternal and neonatal outcomes are collected from the patients' electronic records. Blood pressure and compliance rate will be obtained from an online digital coordination platform for remote data handling. Information about the healthcare-related costs will be obtained from the National Coordination Committee of Belgian Health Insurance Companies (Intermutualistisch Agentschap). PROMS will be assessed using validated questionnaires. DISCUSSION:To our knowledge, this is the first randomized trial comparing midwife-assisted RM and self-monitoring of prenatal blood pressure versus conventional management among women at increased risk of GHD. Positive results of this study may lead to a practical framework for caregivers, hospital management, and payers to introduce RM into the prenatal care programs of high-risk pregnancies. TRIAL REGISTRATION:This study was registered on clinicaltrials.gov , identification number NCT04031430. Registered 24 July 2019, https://clinicaltrials.gov/ct2/show/NCT04031430?cond=premom+ii&draw=2&rank=1 .
| S-EPMC7565319 | biostudies-literature
Project description:BackgroundHypertension 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/designThis 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.DiscussionThough 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.Trial registrationThe trial was registered with Clinicaltrials.gov (identifier: NCT02283697) on 2 November 2014.
| S-EPMC4479223 | biostudies-literature
Project description:Rationale: Sepsis patients suffer from severe metabolic and immunologic dysfunction that may be amplified by standard carbohydrate-based nutritional regimes. We therefore hypothesize that a ketogenic diet improves sepsis treatment. Objectives: We investigated the safety and feasibility of a ketogenic diet in sepsis patients. Methods: We conducted a monocentric open-labeled randomized controlled trial (DRKS00017710) enrolling adult sepsis patients randomly assigned to either ketogenic or standard high-carbohydrate diet for 14 days with follow-up until day 30. The primary outcome measure was β-hydroxybutyrate serum concentration on day 14. Secondary outcomes included safety, clinical and immunological changes. Measurements and Main Results: 40 critically ill septic patients were assigned to the study groups. Increase in β-hydroxybutyrate concentrations from baseline to day 14 was markedly greater under ketogenic diet (1.2 ±0.9) compared to controls (-0.3 ±0.4); estimated mean difference 1.4 (95%-CI 1.0-1.8; p<0.0001). During ketogenic diet, no patient required insulin treatment beyond day 4, whereas 35% to 60% of control patients did (p=0.0095). Metabolic side effects were not observed under ketogenic diet. Ventilation-free (IRR 1.7; 95%-CI: 1.5 to 2.1; p<0.0001), vasopressor-free (IRR 1.7; 95%-CI: 1.5 to 2.0; p<0.0001), dialysis-free (IRR 1.5; 95%-CI: 1.3 to 1.8; p<0.0001), and ICU-free days (IRR 1.7; 95%-CI: 1.4 to 2.1; p<0.0001) significantly increased in patients under ketogenic diet. There was no difference in 30-day mortality. Analyses indicated favorable changes towards immune homeostasis. Conclusions: Ketogenic diet is a feasible and safe nutritional regimen in septic patients promoting recovery from sepsis-related organ dysfunction and could become a new tool in modern treatment concepts.
2024-06-13 | PXD046061 | Pride
Project description:BackgroundPatients in acute care wards who deteriorate and are emergently transferred to intensive care units (ICUs) have poor outcomes. Early identification of patients who are decompensating might allow for earlier clinical intervention and reduced morbidity and mortality. Advances in bedside continuous predictive analytics monitoring (ie, artificial intelligence [AI]-based risk prediction) have made complex data easily available to health care providers and have provided early warning of potentially catastrophic clinical events. We present a dynamic, visual, predictive analytics monitoring tool that integrates real-time bedside telemetric physiologic data into robust clinical models to estimate and communicate risk of imminent events. This tool, Continuous Monitoring of Event Trajectories (CoMET), has been shown in retrospective observational studies to predict clinical decompensation on the acute care ward. There is a need to more definitively study this advanced predictive analytics or AI monitoring system in a prospective, randomized controlled, clinical trial.ObjectiveThe goal of this trial is to determine the impact of an AI-based visual risk analytic, CoMET, on improving patient outcomes related to clinical deterioration, response time to proactive clinical action, and costs to the health care system.MethodsWe propose a cluster randomized controlled trial to test the impact of using the CoMET display in an acute care cardiology and cardiothoracic surgery hospital floor. The number of admissions to a room undergoing cluster randomization was estimated to be 10,424 over the 20-month study period. Cluster randomization based on bed number will occur every 2 months. The intervention cluster will have the CoMET score displayed (along with standard of care), while the usual care group will receive standard of care only.ResultsThe primary outcome will be hours free from events of clinical deterioration. Hours of acute clinical events are defined as time when one or more of the following occur: emergent ICU transfer, emergent surgery prior to ICU transfer, cardiac arrest prior to ICU transfer, emergent intubation, or death. The clinical trial began randomization in January 2021.ConclusionsVery few AI-based health analytics have been translated from algorithm to real-world use. This study will use robust, prospective, randomized controlled, clinical trial methodology to assess the effectiveness of an advanced AI predictive analytics monitoring system in incorporating real-time telemetric data for identifying clinical deterioration on acute care wards. This analysis will strengthen the ability of health care organizations to evolve as learning health systems, in which bioinformatics data are applied to improve patient outcomes by incorporating AI into knowledge tools that are successfully integrated into clinical practice by health care providers.Trial registrationClinicalTrials.gov NCT04359641; https://clinicaltrials.gov/ct2/show/NCT04359641.International registered report identifier (irrid)DERR1-10.2196/29631.
| S-EPMC8285742 | biostudies-literature