Sodium Watchers Program - Hypertension

NCT04076280 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2021-12-20

No results posted yet for this 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.

Conditions

Interventions

BEHAVIORAL

Sodium Watcher Program-Hypertension

The Sodium Watcher Program -Hypertension intervention consists of 14 weeks of education \[4 weekly education sessions (45 minutes)followed by 5 bi-weekly sessions 5-20 minutes\] that will be held at the dyads' preferred time delivered to their homes using a video conferencing program through an iPad.

BEHAVIORAL

Usual Care

Participants in the usual care group receive their routine medical and nursing care for hypertension that consists of a recommendation to follow a sodium restricted diet and take medications as ordered. Usual care consists of recommendations to follow a sodium restricted diet, but without explicit skills training including instructions on gradual adaptation to sodium restricted diet, follow-up of progress or provision of monitoring.

Sponsors & Collaborators

  • Misook L. Chung

    lead OTHER

Principal Investigators

  • Misook L Chung, PhD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2021-08-19
Completion
2021-08-19

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04076280 on ClinicalTrials.gov