Dataset Information

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).

ABSTRACT: 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. TRIAL REGISTRATION:ClinicalTrials.gov NCT03099343; https://clinicaltrials.gov/ct2/show/NCT03099343 (Archived by WebCite at http://www.webcitation.org/735HNzKlQ). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/11282.

SUBMITTER: Dorsch MP

PROVIDER: S-EPMC6303672 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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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).

Dorsch Michael P MP An Lawrence C LC Hummel Scott L SL

JMIR research protocols 20181207 12

<h4>Background</h4>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.<h4>Objective</h4>This study proposes that a mobile app intervention that promotes low-sodium alternatives at grocery stores and ...[more]

PMID: 30530462

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Project description: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.

Project description:BackgroundRisk-appropriate prenatal care has been asserted as a way for the cost-effective delivery of prenatal care. A virtual care model for prenatal care has the potential to provide patient-tailored, risk-appropriate prenatal educational content and may facilitate vital sign and weight monitoring between visits. Previous studies have demonstrated a safe reduction in the frequency of in-person prenatal care visits among low-risk patients but have noted a reduction in patient satisfaction.ObjectiveThe primary objective of this study was to test the effectiveness of a mobile prenatal care app to facilitate a reduced in-person visit schedule for low-risk pregnancies while maintaining patient and provider satisfaction.MethodsThis controlled trial compared a control group receiving usual care with an experimental group receiving usual prenatal care and using a mobile prenatal care app. The experimental group had a planned reduction in the frequency of in-person office visits, whereas the control group had the usual number of visits. The trial was conducted at 2 diverse outpatient obstetric (OB) practices that are part of a single academic center in Washington, DC, United States. Women were eligible for enrollment if they presented to care in the first trimester, were aged between 18 and 40 years, had a confirmed desired pregnancy, were not considered high-risk, and had an iOS or Android smartphone that they used regularly. We measured the effectiveness of a virtual care platform for prenatal care via the following measured outcomes: the number of in-person OB visits during pregnancy and patient satisfaction with prenatal care.ResultsA total of 88 patients were enrolled in the study, 47 in the experimental group and 41 in the control group. For patients in the experimental group, the average number of in-person OB visits during pregnancy was 7.8 and the average number in the control group was 10.2 (P=.01). There was no statistical difference in patient satisfaction (P>.05) or provider satisfaction (P>.05) in either group.ConclusionsThe use of a mobile prenatal care app was associated with reduced in-person visits, and there was no reduction in patient or provider satisfaction.Trial registrationClinicalTrials.gov NCT02914301; https://clinicaltrials.gov/ct2/show/NCT02914301 (Archived by WebCite at http://www.webcitation.org/76S55M517).

Project description:BackgroundMost mental health disorders are first experienced in childhood. The rising rates of mental health difficulties in children highlight the need for innovative approaches to supporting children and preventing these difficulties. School-based digital interventions that address shared risk factors and symptoms, such as emotion dysregulation, present exciting opportunities to enhance mental health support for children on a larger scale.ObjectiveThis study investigates the use of a new app-based intervention designed to support children's emotion regulation in schools. The aim is to optimize the usability, acceptability, and utility of the app and explore its scope for implementation with the target user in the school context.MethodsAs part of an interdisciplinary development framework, the app is being evaluated in a 3-month trial across 4 primary schools. In total, 144 children (aged 10-12 years) took part and accessed the intervention app in the classroom or at home. Outcomes regarding usability, acceptability, and implementation opportunities were assessed through digital user data, self-report questionnaires (132/144, 91.6%), and semistructured interviews with children (19/144, 13.2%) and teachers (6/8, 75%).ResultsThe app usage data showed that 30% (128/426) of the users were returning users. Self-report data indicated that 40.1% (53/132) of the children had not used the app, whereas 57.5% (76/132) had used it once or more. Of the children who had used the app, 67% (51/76) reported that the app was helpful. Interviews with children and teachers suggested positive experiences with the app and that it helped them to calm down and relax. Children reported that they perceived the app as acceptable, usable, and helpful. In terms of the intervention's usability, most features functioned well; however, certain technical issues were reported, which may have led to reduced engagement levels. Teachers not only reported overall positive experiences but also discussed access difficulties and reported a lack of content as one of the main barriers to implementing the app. Having a web-based app significantly enhanced accessibility across devices and settings and provided teachers with more opportunities to use it. We identified the need for new, activating app features in addition to the existing, primarily relaxing ones. The findings indicated that it is possible to use and evaluate an app intervention in the school context and that the app could help enhance children's emotion regulation. We discuss areas for improvement regarding the app, study design, and future implementation strategies.ConclusionsWe share important insights with regard to the development, implementation, and evaluation of a new app for supporting children's emotion regulation in schools. Our results demonstrate that mental health apps represent a promising means to facilitate effective mental health service provision in and outside of the school context. Important lessons learned are shared to support other researchers and clinicians on similar journeys.

Project description:BackgroundCollege students experience high levels of stress. Mindfulness meditation delivered via a mobile app may be an appealing, efficacious way to reduce stress in college students.ObjectiveWe aimed to test the initial efficacy and sustained effects of an 8-week mindfulness meditation mobile app-Calm-compared to a wait-list control on stress, mindfulness, and self-compassion in college students with elevated stress. We also explored the intervention's effect on health behaviors (ie, sleep disturbance, alcohol consumption [binge drinking], physical activity, and healthy eating [fruit and vegetable consumption]) and the feasibility and acceptability of the app.MethodsThis study was a randomized, wait-list, control trial with assessments at baseline, postintervention (8 weeks), and at follow-up (12 weeks). Participants were eligible if they were current full-time undergraduate students and (1) at least 18 years of age, (2) scored ≥14 points on the Perceived Stress Scale, (3) owned a smartphone, (4) were willing to download the Calm app, (5) were willing to be randomized, and (7) were able to read and understand English. Participants were asked to meditate using Calm at least 10 minutes per day. A P value ≤.05 was considered statistically significant.ResultsA total of 88 participants were included in the analysis. The mean age (SD) was 20.41 (2.31) years for the intervention group and 21.85 (6.3) years for the control group. There were significant differences in all outcomes (stress, mindfulness, and self-compassion) between the intervention and control groups after adjustment for covariates postintervention (all P<.04). These effects persisted at follow-up (all P<.03), except for the nonreacting subscale of mindfulness (P=.08). There was a significant interaction between group and time factors in perceived stress (P=.002), mindfulness (P<.001), and self-compassion (P<.001). Bonferroni posthoc tests showed significant within-group mean differences for perceived stress in the intervention group (P<.001), while there were no significant within-group mean differences in the control group (all P>.19). Similar results were found for mindfulness and self-compassion. Effect sizes ranged from moderate (0.59) to large (1.24) across all outcomes. A significant group×time interaction in models of sleep disturbance was found, but no significant effects were found for other health behaviors. The majority of students in the intervention group reported that Calm was helpful to reduce stress and stated they would use Calm in the future. The majority were satisfied using Calm and likely to recommend it to other college students. The intervention group participated in meditation for an average of 38 minutes/week during the intervention and 20 minutes/week during follow-up.ConclusionsCalm is an effective modality to deliver mindfulness meditation in order to reduce stress and improve mindfulness and self-compassion in stressed college students. Our findings provide important information that can be applied to the design of future studies or mental health resources in university programs.Trial registrationClinicalTrials.gov NCT03891810; https://clinicaltrials.gov/ct2/show/NCT03891810.

Project description:Residual cardiovascular risk persists despite statins, yet outcome studies of lipid-targeted therapies beyond low-density lipoprotein cholesterol (LDL-C) have not demonstrated added benefit. Triglyceride elevation is an independent risk factor for cardiovascular events. High-dose eicosapentaenoic acid (EPA) reduces triglyceride-rich lipoproteins without raising LDL-C. Omega-3s have postulated pleiotropic cardioprotective benefits beyond triglyceride-lowering. To date, no large, multinational, randomized clinical trial has proved that lowering triglycerides on top of statin therapy improves cardiovascular outcomes. The Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial (REDUCE-IT; NCT01492361) is a phase 3b randomized, double-blinded, placebo-controlled trial of icosapent ethyl, a highly purified ethyl ester of EPA, vs placebo. The main objective is to evaluate whether treatment with icosapent ethyl reduces ischemic events in statin-treated patients with high triglycerides at elevated cardiovascular risk. REDUCE-IT enrolled men or women age ≥45 years with established cardiovascular disease or age ≥50 years with diabetes mellitus and 1 additional risk factor. Randomization required fasting triglycerides ≥150 mg/dL and <500 mg/dL and LDL-C >40 mg/dL and ≤100 mg/dL with stable statin (± ezetimibe) ≥4 weeks prior to qualifying measurements. The primary endpoint is a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina. The key secondary endpoint is the composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Several secondary, tertiary, and exploratory endpoints will be assessed. Approximately 8000 patients have been randomized at approximately 470 centers worldwide. Follow-up will continue in this event-driven trial until approximately 1612 adjudicated primary-efficacy endpoint events have occurred.

Project description:BackgroundBreastfeeding is proven to have lasting health benefits for both mothers and infants; however, 6-month exclusive breastfeeding rate remains below 20% in Thailand. Although the number of research literature and commercial apps for breastfeeding women is significantly growing, they are country-specific and restricted to English-speaking users. There exists a major knowledge gap on how mobile health apps could support breastfeeding in Thailand. To address these gaps, MoomMae has been developed with the intention to support Thai women in breastfeeding outside of their homes and in keeping their feeding records.ObjectiveThe aim of this study was to evaluate the usability and usefulness of MoomMae, a mobile phone app designed to support breastfeeding women.MethodsOur study was reviewed and approved by Thailand's National Science and Technology Development Agency (NSTDA) ethics committee. A total of 21 breastfeeding women with at least one Android phone or tablet were recruited via convenience and snowball sampling. The study process for each participant was as follows: the participant was requested to attend a preuse interview and given the app to use for 4 weeks. Following this period, a postuse interview was conducted to examine the usability and usefulness of the app. Both sessions were held individually and audiorecorded for qualitative analysis.ResultsThe mean scores of usability and usefulness from the postuse survey were 4.33 (SD 0.87; range 1-5) and 4.60 (SD 0.74; range 2-5). Our qualitative analysis revealed a total of 137 feedbacks: 71 related to usability and 66 associated with usefulness. A further sentimental analysis showed that comments on usability were generally negative (59 negative, 11 positive, and 1 neutral), and comments on usefulness were relatively positive (56 positive, 9 negative, and 1 neutral). We discovered 26 unique design issues and proposed recommendations for future improvement.ConclusionsOur usability and usefulness assessment of MoomMae demonstrated that MoomMae has a great potential to be a useful self-management tool for breastfeeding mothers in Thailand. The qualitative analysis suggested that the app is supportive of breastfeeding on demand, but the flow and inputs of the app should be redesigned to be more intuitive. For future implementations, the most desirable feature is a pump-reminding notification system.

Dataset Information

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).

Publications

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).

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