ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02679690
Recruitment Status : Unknown
Verified April 2016 by Sheryl Ondrejko, University of Pittsburgh.
Recruitment status was:  Recruiting
First Posted : February 10, 2016
Last Update Posted : April 13, 2016
Sponsor:
Information provided by (Responsible Party):
Sheryl Ondrejko, University of Pittsburgh

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.


Condition or disease Intervention/treatment Phase
Diet, Sodium-Restricted Heart Failure C14.280.434 Behavioral: Standard Dietary Sodium Education Behavioral: Color-Coded Cue Cards Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Study Start Date : November 2015
Actual Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with Heart Failure
Patients with heart failure receiving standard dietary sodium education and then color-coded cue card education and intervention.
Behavioral: Standard Dietary Sodium Education
Standard dietary education for sodium restricted diets for patients with heart failure.

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.




Primary Outcome Measures :
  1. Average milligrams of dietary sodium in chosen foods [ Time Frame: one month ]

Secondary Outcome Measures :
  1. Comparison of milligrams of sodium pre and post intervention [ Time Frame: one month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679690


Contacts
Contact: Sheryl A Ondrejko, MSN 7247479607 sherylannmarieo@gmail.com

Locations
United States, Pennsylvania
Washington Health System Greene Recruiting
Waynesburg, Pennsylvania, United States, 15370
Principal Investigator: Sheryl A Ondrejko, MSN         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Sheryl A Ondrejko, MSN University of Pittsburgh

Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site

Responsible Party: Sheryl Ondrejko, Principal Investigator, MSN, RN, DNP Candidate, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02679690     History of Changes
Other Study ID Numbers: PRO14110506
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases