Assessing Knowledge of Dietary Sodium Content and Implementation of Color-Coded Cue Cards and Dietary Sodium

NCT ID: NCT02679690

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-04-30

Brief Summary

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.

Detailed Description

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.

Conditions

Diet, Sodium-Restricted; Heart Failure C14.280.434

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard dietary sodium education

Standard dietary sodium education provided to patients with heart failure using voice over powerpoint presentation.

Group Type: EXPERIMENTAL

Standard Dietary Sodium Education

Intervention Type: BEHAVIORAL

Standard dietary education for sodium restricted diets for patients with heart failure.

color-coded cue cards

The use of a color-coded cue cards to educate patients with heart failure on dietary sodium. The education regarding the use of the color-coded cue card was provided using a voice over powerpoint presentation.

Group Type: EXPERIMENTAL

Color-Coded Cue Cards

Intervention Type: BEHAVIORAL

The use of a color-coded cue card to designate ranges of acceptable sodium content of food for comparison to labels while grocery shopping.

Interventions

Standard Dietary Sodium Education

Standard dietary education for sodium restricted diets for patients with heart failure.

Intervention Type: BEHAVIORAL

Color-Coded Cue Cards

The use of a color-coded cue card to designate ranges of acceptable sodium content of food for comparison to labels while grocery shopping.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• English speaking
• diagnosed with heart failure

Exclusion Criteria

• Never participated in a heart failure clinic previously
• any patient mentally or physically unable to go grocery shopping

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Sheryl Ondrejko

Principal Investigator, MSN, RN, DNP Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sheryl A Ondrejko, MSN

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Washington Health System Greene

Waynesburg, Pennsylvania, United States

Countries

United States

Study Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

PRO14110506

Identifier Type: -

Identifier Source: org_study_id