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

NCT02679690 | Completed Results

• 1 other identifier: PRO14110506
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet, Sodium-Restricted; Heart Failure C14.280.434

Outcome Measures

Primary Outcomes (1)

• Difference in Mean Milligrams of Dietary Sodium in Chosen Foods Pre- and Post- Color Coded Cue Card Intervention

  Each participant chose 15 grocery items at baseline (before) and after color-coded cue card dietary sodium education intervention. The outcome was the difference of the paired mean of each participant from their 15 grocery items chosen pre and post intervention.

  two weeks and one month

Secondary Outcomes (1)

• Mean of Milligrams of Sodium for All Grocery Items That Were Chosen by the Total of All Participants Pre, and Post Intervention

  two weeks and one month

Study Arms (2)

Standard dietary sodium education

EXPERIMENTAL

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

Behavioral: Standard Dietary Sodium Education

color-coded cue cards

EXPERIMENTAL

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.

Behavioral: Color-Coded Cue Cards

Interventions

Standard Dietary Sodium Education BEHAVIORAL

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

Standard dietary sodium education

Color-Coded Cue Cards 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.

color-coded cue cards

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• diagnosed with heart failure

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Washington Health System Greene

Waynesburg, Pennsylvania, 15370, United States

Location

Limitations and Caveats

* Small sample size * a single community-based cardiology practice, a self-selected sample

Results Point of Contact

• Title: Sheryl Ondrejko, DNP
• Organization: University of Pittsburgh

sherylannmarieo@gmail.com

Study Officials

• Sheryl A Ondrejko, MSN

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MSN, RN, DNP Candidate

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 10, 2016
• Study Start: November 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: February 15, 2019
• Results First Posted: February 15, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)