- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02679690
Assessing Knowledge of Dietary Sodium Content and Implementation of Color-Coded Cue Cards and Dietary Sodium
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Waynesburg, Pennsylvania, United States, 15370
- Washington Health System Greene
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Standard dietary sodium education
Standard dietary sodium education provided to patients with heart failure using voice over powerpoint presentation.
|
Standard dietary education for sodium restricted diets for patients with heart failure.
|
Experimental: 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.
|
The use of a color-coded cue card to designate ranges of acceptable sodium content of food for comparison to labels while grocery shopping.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in Mean Milligrams of Dietary Sodium in Chosen Foods Pre- and Post- Color Coded Cue Card Intervention
Time Frame: two weeks and one month
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean of Milligrams of Sodium for All Grocery Items That Were Chosen by the Total of All Participants Pre, and Post Intervention
Time Frame: two weeks and one month
|
All 15 grocery items were tallied for all ten participants after the first standard dietary sodium education, with the mean obtained.
This was repeated with the 9 participants who chose 15 grocery items after completing the color-coded cue card education intervention.
|
two weeks and one month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sheryl A Ondrejko, MSN, University of Pittsburgh
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO14110506
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diet, Sodium-Restricted
-
University of GlasgowSuspendedDiet, Carbohydrate-restrictedUnited Kingdom
-
Instituto Mexicano del Seguro SocialCompletedEffect of Sodium Intake on Brain Natriuretic Peptide Levels in Patients With Heart Failure (SODA-HF)Heart Failure, Systolic | Clinical Trial | Natriuretic Peptide, Brain | Diet, Sodium-RestrictedMexico
-
Texas A&M UniversityCurves InternationalCompletedDiet, Carbohydrate-Restricted
-
University of DelawareRecruitingDiet, Healthy | Eating Behavior | Nutrition, Healthy | Time Restricted EatingUnited States
-
University of AdelaideAustralian Catholic University; La Trobe UniversityRecruitingDiet Quality | Time-restricted EatingAustralia
-
Barbara Jakše s.p.CompletedBody Weight | Sleep | Cardiovascular Risk Factor | Diet, Healthy | Motivation | Time Restricted FeedingSlovenia
-
University of California, BerkeleyUniversity of British Columbia; University College, London; Wellcome Trust; Salk... and other collaboratorsNot yet recruitingTime Restricted Eating | Diet, MediterraneanUnited States
-
Instituto de Investigación Marqués de ValdecillaTerminatedArterial Hypertension | Diet Habit | Sodium Urine | Primary Care CenterSpain
-
Baylor Research InstituteActive, not recruitingHypertension | Risk Reduction Behavior | African Americans | Diet, Carbohydrate-RestrictedUnited States
-
Western University, CanadaUnknowneTRE (Early Time Restricted Eating) | lTRE (Late Time Restricted Eating)Canada
Clinical Trials on Standard Dietary Sodium Education
-
DongGuk UniversityMinistry of Food and Drug Safety, KoreaUnknownHypertension | PrehypertensionKorea, Republic of
-
Steno Diabetes Center CopenhagenUniversity of CopenhagenCompletedGlucose Metabolism Disorders | Diabetes Mellitus, Type 2 | Type2 DiabetesDenmark
-
Hospital Israelita Albert EinsteinNot yet recruitingDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type 1
-
Northumbria UniversityNewcastle-upon-Tyne Hospitals NHS TrustRecruitingSarcopenia | Coronary Heart Disease | Low Protein IntakeUnited Kingdom
-
McGill UniversityMcMaster University; University of Sydney; Institut National du Sport du QuebecRecruiting
-
Rajavithi HospitalCompleted
-
University Hospitals of North Midlands NHS TrustRecruitingAsthma | Asthma in ChildrenUnited Kingdom
-
AstraZenecaTerminatedHyperkalaemiaUnited States
-
University of OklahomaRecruitingObesity | Bariatric Surgery Candidate | Endometrial CancerUnited States
-
Ohio State UniversityFoundation for Physical Therapy, Inc.CompletedPain | Hip Injuries | Therapy/RehabilitationUnited States