Diet, Sodium-RestrictedNCT02679690
Assessing Knowledge of Dietary Sodium Content and Implementation of Color-Coded Cue Cards and Dietary Sodium
A study testing Standard Dietary Sodium Education and Color-Coded Cue Cards in people with Diet, Sodium-Restricted and Heart Failure C14.280.434, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diet, Sodium-Restricted, Heart Failure C14.280.434
- What is being tested?
- Standard Dietary Sodium Education and Color-Coded Cue Cards
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- diagnosed with heart failure
Who cannot join
- Never participated in a heart failure clinic previously
- any patient mentally or physically unable to go grocery shopping
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Health System Greene
Waynesburg, Pennsylvania, 15370
About this study
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.
Read the 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
- Being tested
- Standard Dietary Sodium Education, Color-Coded Cue Cards
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Dietary Sodium EducationBehavioural
Standard dietary education for sodium restricted diets for patients with heart failure.
Color-Coded Cue CardsBehavioural
The use of a color-coded cue card to designate ranges of acceptable sodium content of food for comparison to labels while grocery shopping.
| Study group | Role | What they receive |
|---|---|---|
| Standard dietary sodium education | Experimental | Standard dietary sodium education provided to patients with heart failure using voice over powerpoint presentation. Receives: 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. Receives: Behavioral: Color-Coded Cue Cards |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: two weeks and one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startNov 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diet, Sodium-RestrictedStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheryl Ondrejko, University of Pittsburgh
- Investigators
- Sheryl A Ondrejko, MSN, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679690
- Sponsor's protocol ID
- PRO14110506
- Status last verified
- Sep 2018
- First submitted
- 5 Feb 2016
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02679690
- Acronym / sponsor ID
- PRO14110506
- Conditions
- Diet, Sodium-Restricted, Heart Failure C14.280.434
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Posted 15 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard dietary sodium education | Experimental | Behavioral: Standard Dietary Sodium EducationStandard dietary sodium education provided to patients with heart failure using voice over powerpoint presentation. |
| color-coded cue cards | Experimental | Behavioral: Color-Coded Cue CardsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English speaking
- diagnosed with heart failure
Key exclusion criteria (2 listed)
- Never participated in a heart failure clinic previously
- any patient mentally or physically unable to go grocery shopping
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Dietary Sodium EducationStandard dietary education for sodium restricted diets for patients with heart failure. | Behavioural | Standard dietary sodium education |
| Color-Coded Cue CardsThe use of a color-coded cue card to designate ranges of acceptable sodium content of food for comparison to labels while grocery shopping. | Behavioural | color-coded cue cards |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheryl A Ondrejko, MSN principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Dietary Sodium Education and Color-Coded Cue Cards in people with Diet, Sodium-Restricted and Heart Failure C14.280.434, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.