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)

10.2196/11282 ◽  
2018 ◽  
Vol 7 (12) ◽  
pp. e11282 ◽  
Author(s):  
Michael P Dorsch ◽  
Lawrence C An ◽  
Scott L Hummel
Keyword(s):  
Randomized Controlled Trial ◽  
Sodium Intake ◽  
Controlled Trial ◽  
Mobile App ◽  
Just In Time ◽  
Randomized Controlled ◽  
Reduce Sodium Intake

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
Keyword(s):  
Blood Pressure ◽  
Sodium Intake ◽  
Controlled Trial ◽  
Mobile App ◽  
Just In Time ◽  
Grocery Stores ◽  
Randomized Controlled ◽  
Low Sodium Diet ◽  
Tailored Messages ◽  
Low Sodium

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

scholarly journals Mobile app for treatment of stress urinary incontinence: A randomized controlled trial

2016 ◽  
Vol 36 (5) ◽  
pp. 1369-1376 ◽  
Author(s):  
Ina Asklund ◽  
Emma Nyström ◽  
Malin Sjöström ◽  
Göran Umefjord ◽  
Hans Stenlund ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Urinary Incontinence ◽  
Stress Urinary Incontinence ◽  
Controlled Trial ◽  
Mobile App ◽  
Randomized Controlled

scholarly journals Testing a mindfulness meditation mobile app for the treatment of sleep-related symptoms in adults with sleep disturbance: A randomized controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (1) ◽  
pp. e0244717
Author(s):  
Jennifer L. Huberty ◽  
Jeni Green ◽  
Megan E. Puzia ◽  
Linda Larkey ◽  
Breanne Laird ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Sleep Disturbance ◽  
Daytime Sleepiness ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mobile App ◽  
Wait List ◽  
Wait List Control ◽  
Randomized Controlled ◽  
Sleep Arousal

The objective of this randomized controlled trial was to test whether a commercially available, mindfulness meditation mobile app, (i.e., Calm app), was effective in reducing fatigue (primary outcome), pre-sleep arousal, and daytime sleepiness (secondary outcomes) in adults with sleep disturbance (Insomnia Severity Index Score >10) as compared to a wait-list control group. Associations between the use of the Calm app (i.e., adherence to the intervention) and changes in sleep quality was also explored in the intervention group only. Adults with sleep disturbance were recruited (N = 640). Eligible and consenting participants (N = 263) were randomly assigned to the intervention (n = 124) or a wait-list control (n = 139) group. Intervention participants were asked to meditate using the Calm app ≥10 minutes/day for eight weeks. Fatigue, daytime sleepiness, and pre-sleep arousal were assessed at baseline, mid- (4-weeks) and post-intervention (8-weeks) in both groups, whereas sleep quality was evaluated only in the intervention group. Findings from intent-to-treat analyses suggest the use of the Calm app for eight weeks significantly decreased daytime fatigue (p = .018) as well as daytime sleepiness (p = .003) and cognitive (p = .005) and somatic (p < .001) pre-sleep arousal as compared to the wait-list control group. Within the intervention group, use of the Calm app was associated with improvements in sleep quality (p < .001). This randomized controlled trial demonstrates that the Calm app can be used to treat fatigue, daytime sleepiness, and pre-sleep arousal in adults with sleep disturbance. Given that the Calm app is affordable and widely accessible, these data have implications for community level dissemination of a mobile app to improve sleep-related symptoms associated with sleep disturbance. Trial registration: ClinicalTrials.gov NCT04045275.

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