Trial Outcomes & Findings for Assessing Knowledge of Dietary Sodium Content and Implementation of Color-Coded Cue Cards and Dietary Sodium (NCT NCT02679690)

NCT ID: NCT02679690

Last Updated: 2019-02-15

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: two weeks and one month
• Results posted on: 2019-02-15

Participant Flow

Participant milestones

Measure	Patients With Heart Failure Patients with heart failure receiving standard dietary sodium education and then color-coded cue card education and intervention. Standard Dietary Sodium Education: Standard dietary education for sodium restricted diets for patients with heart failure. 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.
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Patient Population Pre Intervention n=10 Participants Patients with heart failure demographics who recieved standard dietary sodium education
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Education Level	10 participants n=5 Participants

PRIMARY outcome

Timeframe: two weeks and one month

Population: 9 participants who completed both PowerPoint educations and both grocery store food choices.

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.

Outcome measures

Measure	Patients With Heart Failure n=9 Participants Patients with heart failure receiving standard dietary sodium education and then color-coded cue card education and intervention. Standard Dietary Sodium Education: Standard dietary education for sodium restricted diets for patients with heart failure. 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.	Participants Dietary Sodium Choices Post Color-coded Cue Card The mean milligrams of dietary sodium from the 15 grocery items chosen post color-coded cue card education intervention.
Difference in Mean Milligrams of Dietary Sodium in Chosen Foods Pre- and Post- Color Coded Cue Card Intervention	173.78 milligrams Standard Deviation 61.47	—

SECONDARY outcome

Timeframe: two weeks and one month

Population: The mean milligrams of sodium per serving from the 15 items of groceries chosen after standardized dietary sodium education, and then again after the education regarding the use of color-coded cue cards for dietary sodium.

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.

Outcome measures

Measure	Patients With Heart Failure n=10 Participants Patients with heart failure receiving standard dietary sodium education and then color-coded cue card education and intervention. Standard Dietary Sodium Education: Standard dietary education for sodium restricted diets for patients with heart failure. 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.	Participants Dietary Sodium Choices Post Color-coded Cue Card n=9 Participants The mean milligrams of dietary sodium from the 15 grocery items chosen post color-coded cue card education intervention.
Mean of Milligrams of Sodium for All Grocery Items That Were Chosen by the Total of All Participants Pre, and Post Intervention	230.3000 milligrams Standard Deviation 65.14778	47.1111 milligrams Standard Deviation 5.64456

Adverse Events

Patients With Heart Failure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sheryl Ondrejko, DNP

University of Pittsburgh

Email: sherylannmarieo@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place