Diet, Sodium-Restricted Clinical Trial
Official title:
Assessing Knowledge of Dietary Sodium Content and Implementation of Color-Coded Cue Cards to Aid in Improving Adherence to Low Sodium Diets in Patients With Heart Failure.
Develop an evidence-based intervention aimed at patients with heart failure (HF) using
color-coded cue cards to assist in the selection of foods appropriate to their sodium
restricted diet. The milligram per serving sodium content of foods will be assigned
color-coded green/yellow/red designation according to very low/moderate/high as identified by
the United States Food and Drug Administration's definitions of sodium content.
Assess patient knowledge of foods with sodium content appropriate for consumption on a low
sodium diet before implementation of the intervention by calculating average milligrams of
sodium per serving via choices made through simulated grocery store shopping.
Evaluate application of patient knowledge about low-sodium food choices using a simulated
grocery store shopping intervention by calculating average milligrams of sodium per serving
via choices made using the color-coded card.
Each new patient referred to the heart failure (HF) clinic will be asked for their permission
to participate in this project. Each patient enrolled in the project will have a random
number assigned to protect identity, which will be assigned to their baseline data as well as
food tally score sheets before and after intervention. Baseline data collection will include
patient's sex, age,marital status, comorbidities, and education level. Using guidelines from
the Centers for Disease Control (CDC) and Prevention and the Food & Drug Administration
(FDA), to ensure consistency, all participating patients will be given standard dietary
sodium education using a voice-over PowerPoint presentation. Approximately two weeks later,
the patients will be asked to "shop" for 15 food items at a simulated grocery store. This
same group of patients will then be given the evidence based intervention using a second
voice-over PowerPoint presentation. During this presentation, participants will be instructed
on how to use color-coded cards to assist them in choosing foods based on low/moderate/high
sodium content. Green indicates foods with less than 35 mg of sodium per serving, yellow
indicates foods with 35-140 mg of sodium per serving, and red indicates foods with more than
140 mg of sodium per serving. Approximately two additional weeks later, the patients will
again go "shopping" for fifteen items in the same simulated grocery store using the
color-coded cards that allow the patient to choose foods based on low/moderate/high sodium
content. The food choices made at each grocery store encounter will be analyzed by totaling
the sodium content per serving of all foods divided by the number of foods purchased
(fifteen) to obtain an average milligram of sodium content per serving and then analyzed per
patient, comparing that patient's pre- and post-intervention sodium per serving food choices.
The average milligram of sodium per serving will be compared for each patient pre- and
post-color-coded card use. The average milligrams of sodium per serving of all patients
together will be totaled before the use of color-coded cards and after the use of color-coded
cards. This project will assess if use of a color-coded method of dietary sodium labeling
helps patients stay within their sodium restricted dietary range.
A checklist with each grocery item in the store will be used to identify and tally which
products each patient chooses on each shopping trip. Each checklist will also be identified
only by the assigned patient number. Staff will be instructed to provide no further dietary
sodium instruction to any patient. Staff will not assist the patient in choosing grocery
store items on either shopping trip, and will not comment to reinforce or discourage patient
food choices during shopping.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03351283 -
Effect of Sodium Intake on Brain Natriuretic Peptide Levels in Patients With Heart Failure
|
N/A |