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NCT04076280 · ClinicalTrials.gov registry record · NA
Sodium Watchers Program - Hypertension
A NA study of Hypertension, sponsored by Misook L. Chung.
- Completed
- Registry status
- NA
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT04076280: Completed NA study of Hypertension, sponsored by Misook L. Chung.
NCT04076280 is a NA study of Hypertension that has completed, run by Misook L. Chung. The registered enrollment target is 29 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04076280, a NA study of Hypertension, has completed, sponsored by Misook L. Chung.
- COMPLETED
- Registry status
- NA
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
Hypertensive adults are a vulnerable population at high risk of developing cardiovascular disease. Despite the many interventions tested to reduce hypertension, it remains a major risk factor that is not appropriately managed in the population. Prior dietary interventions were successful on reduction of sodium intake, but the changes were not maintained after the end of the intervention. We propose that changing patients' salt taste preference and including family members will produce long-term changes in sodium intake and blood pressure. The Sodium Watchers Program (SWaP) proposed in this study is designed to improve adherence to a sodium restricted diet through education and self-care strategies for gradual taste adaptation to low salt foods. The purpose of this pilot is to test short-term effects of the SWaP intervention on adherence to the sodium restricted diet, blood pressure, salt taste preference, and dietary patterns in hypertensive adults. A total of 30 hypertensive adults will be randomly assigned to the intervention (n=20) or control group (n=10). The intervention group will receive 16-weeks of education and booster sessions remotely using a video conferencing program on mini-iPads. All participants will collect a 24-hour urine specimen for sodium excretion and complete assessments of blood pressure, salt taste preference testing using salt concentration solutions, and dietary pattern using VioScreen Food Frequency Questionnaire at baseline and post intervention at 4-months. Data will be analyzed using repeated measures analysis of variance.
Primary Outcome
Salt taste acuity will be tested by using the "updown" procedure. In the up trial, samples are given from lowest to highest salt concentration. Patients swish samples in the mouth for 2-3 seconds, expectorate, and then judge the saltiness of solution. The mouth is rinsed with 10 mL of distilled water between samples. When patients detect salt taste in two consecutive samples, the lower concentration of the two samples is recorded as the level of salt taste sensitivity. In the down trial, patient
Conditions Studied
Interventions
- BEHAVIORAL Usual Care
- BEHAVIORAL Sodium Watcher Program-Hypertension
Study Locations (1)
Kentucky
- University of Kentucky - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2019-09-01 |
| Est. Completion | 2021-08-19 |
| Phase | NA |
What the finished NCT04076280 record still lists
NCT04076280 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Usual Care is the first listed.
NCT04076280 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT04076280 about?
NCT04076280 is a clinical study titled "Sodium Watchers Program - Hypertension". Hypertensive adults are a vulnerable population at high risk of developing cardiovascular disease. Despite the many interventions tested to reduce hypertension, it remains a major risk factor that is not appropriately managed in the population. Prior dietary interventions were successful on reductio...
What is the current status of trial NCT04076280?
This trial is currently completed. It is a NA study. The enrollment target is 29 participants. The study started on 2019-09-01. Estimated completion is 2021-08-19.
What conditions does trial NCT04076280 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT04076280?
The interventions under investigation include: Usual Care (BEHAVIORAL), Sodium Watcher Program-Hypertension (BEHAVIORAL).
Who is sponsoring clinical trial NCT04076280?
This trial is sponsored by Misook L. Chung, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04076280 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04076280's enrollment target sits among peer trials
29 418th of 470 higher than 53 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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