Effects of Nutrition Education on Sodium Intake in Newly Diagnosed CHF Patients

Proposal By: Monica Moore RD, LD

INTRODUCTION:
Congestive Heart Failure (CHF) is an epidemic in America, affecting over 5 million
Americans, with approximately 550,000 new cases diagnosed each year.1,2 According to the
Centers for Disease Control and Prevention (CDC), about 50% of these patients will die within 5
years of diagnosis.2 Economically, it costs $30-32 billion each year to manage CHF. Typically a
low sodium diet, considered between 1500-2000mg of sodium per day,3,4 is the recommended
standard of care nutritionally for CHF management. The American Heart Association
recommends a trend towards the lower end of that range.4 It has been found that a reduction of
400mg daily of sodium can improve patient outcomes and CHF symptoms.5

OBJECTIVE:
Due to the above need and potential benefits associated with better CHF management,
more research and additional studied interventions for compliance is needed. The research
question to be studied is: Does nutrition education in the form of weekly dietitian visits improve
sodium intake in patients with newly diagnosed CHF recommended to be on a low sodium diet?
The objective of investigating this research question is to determine if regular structured nutrition
education (independent variable) improves compliance to lower sodium intake or results in
decreased sodium intake (dependent variable) and thus improves overall CHF management.

LITERATURE REVIEW:
Reviewing current research, themes around sodium intake and CHF management are
evident. In a controlled randomized study done in Iran, 100 participants were studied to see the
difference in sodium intake between patients with usual care and those with nutrition education.
Similar to this proposed study intervention, the education group participated in six weeks of
education and their sodium intake was measured after the educations and again twelve weeks
later. A urine sodium test was done and questionnaires filled out pre- and post-intervention to
assess differences between the groups. A significant difference was seen in attitude towards diet,
adherence to diet, and perceived behavior control between the control and intervention group.5
A study on the effects of sodium intake and CHF used a systemic review to compare 17
studies over ten years regarding CHF.6 Food recall questionnaires and 24-hour urinary sodium
excretion tests were used to compare between the two different nutrition education groups and
the control group. Researchers found a positive impact from nutritional education on clinical
outcomes, including low sodium diet compliance and hospital readmissions.
Another recent randomized, double-blind, control study compared sodium intake levels
and CHF outcomes in the PROHIBIT sodium study.7 The early interventions of the study
included prepared/packaged meals with a set amount of sodium, either 1500mg daily (low
sodium) or 3000mg daily (control). They were delivered to patients for twelve weeks to control
intake without patient self-selection. For the following twelve weeks, the patients were
monitored for sodium intake while choosing their own foods. The study found that a large
knowledge gap existed in patients regarding sodium intake and that was a limiting factor in their
study not seeing the results they anticipated and moving into the second phase of the study
examining dietary compliance.
Looking again at the nutrition education component as an intervention for CHF
management, a 2014 randomized control study examined the effects of counseling and education
on nutrition and self-management in CHF patients, also with diabetes.8 The study examined
adults aged 21-80 years old using a questionnaire and self-efficacy and quality of life scales. In
the intervention group, two 30-45 minute counseling sessions were provided prior to hospital
discharge and another 15 minute phone session within three days after discharge. Behavior
change, compliance, and disease management after 30 and 90 days were examined. Results
showed that knowledge about CHF improved at the 30-day recheck from baseline, although by
90 days, the mean had returned to the baseline knowledge level. This retracting knowledge level
without regular follow-up after discharge is another reason why continued research on education
interventions more consistently provided may be a beneficial topic to investigate.
Interestingly, an article reviewing CHF adherence to self-care recommendations showed
that out of the 310 people surveyed, only 22.3% actually reported good adherence to overall
recommendations for CHF management and only 64% reported adherence to a low sodium diet.9
These statistics, in addition to other literature reviewed showing the improvements of sodium
intake and disease management with nutrition education and low sodium diet, support the need
for more research on interventions that could improve dietary compliance. Based on current
research summarized above, a gap in literature exists in the newly diagnosed CHF population.

METHODOLOGY:
Design:
The study design for this research will be an experimental quantitative study. It will be a
randomized case-controlled study. A randomized control study is the best way to investigate this
research question because it focuses on inclusion based on disease status and comparing a
control and case group with the same questions to test exposure (education in this case) versus no
exposure.10
The data being collected will be a 24-hour urinary sodium excretion test11, 12, 13 pre- and
post-education to see if patients have improved their sodium intake throughout the study
period. This data will be compared between the control group receiving the standard of care and
the intervention group receiving the standard of care plus weekly nutrition education sessions
with a Registered Dietitian. The doctor's office staff where the patient is already being seen for
CHF and where the education sessions will take place will collect this data and submit it coded
with only numeric identifiers to the researcher for comparison and analysis.
The test used to determine significance of the means is an independent t-test10, utilizing
continuous numerical data. Objective data (24-hour urinary sodium excretion) was chosen over
subjective data (3-day food recall) to reduce error associated with patient recall and potential for
dishonesty from participants about their actual food intake. 24-hour urinary sodium excretion is
also considered to be the most reliable method to evaluate sodium intake in subjects.13
A G Power test performed prior to recruiting participants determined the ideal sample
size needed to see significance using a priori power analysis for difference between means with
medium effect size (0.5) and error of probability of 0.05. The null hypothesis will be considered
rejected when significance is determined based on the independent t-test with p-value less than
or equal to 0.05, meaning there is only a 5% likelihood that results seen were due to chance.10
Participants/Setting:
The sample population will be newly diagnosed CHF patients invited to participate in the
research project through their usual doctor's office or heart clinic visits. Criteria for inclusion is
CHF diagnosis within past 6 months, interest in participating, and over age 18. Exclusions are
those with a CHF diagnosis for over 6 months, age under 18, unwillingness or disinterest in
participating, and/or noncompliance with office visit attendance. Once study period begins, if a
patient misses any of their scheduled physician or weekly dietitian visits they will be excluded
from the study. Those without a new CHF diagnosis are excluded to limit confounding variables
of longer term disease management and unknown already provided nutrition education. A final
exclusion will be if a patient is hospitalized during the six-week study period. Using the G Power
test as previously stated, an ideal total sample size to recruit will be at least 45 people.10
Recruitment will occur in the Portland, Maine area within MaineHealth providers'
offices. This includes hospital-connected physician offices, cardiac rehab programs, and
cardiology clinics. This will allow for a large variety of patients in different age, education, and
economic groups in Maine. Confidentiality of patient data will be upheld by local offices during
recruitment by requesting patient's permission and interest in participation in the study and
allowance to pass along their information to the researcher. Patient names will not be used, rather
will be coded with numerical coded identifiers. Updates, 24-hour urinary sodium excretion
levels, missed appointments, potential reasons for exclusion, and demographics will be provided
to the researcher via electronic files. The researcher will store the data in a computer file with no
personal identifiers used and only the researcher will have access to that file. The data will be put
into an excel file for easy viewing and comparisons and also a statistical software program
(NCSS Data Analysis 2019)14 will be used to perform calculations, such as the t-test.
Participants will randomly be assigned to the control group or intervention group. If
assigned to intervention group, the office will schedule the patient's weekly nutrition visits and
provide the schedule to the patients. HIPPA regulations will be adhered to and participants will
sign an informed consent if selected to participate in the study to be aware of the risks involved
and to assure voluntary participation. (See Appendix A) Participants will not be compensated for
their participation, however will also not be charged for their dietitian access during the study.
Intervention:
Once participants have been recruited, consented, and randomly assigned to each group,
the study period will begin. Those within the control group will receive the usual standard of
care, usual interventions in the doctor's office, and regularly scheduled physician visits. Those
within the intervention group will receive this same usual care plus weekly nutrition counseling
sessions for education on low sodium diet. These dietitian sessions will take place in the office
that the patient is already at for their usual physician appointments which hopefully will
encourage compliance to attendance of these appointments. The sessions will occur over six
weeks, six visits total. A similar time frame was examined in other studies around sodium intake
and compliance with positive results.5 Each visit will be approximately thirty minutes in length.
Furthermore, the intervention group will have access to the dietitian for troubleshooting,
accountability, and encouragement for lower sodium intake in between scheduled sessions via
email or phone. 24-hour urinary sodium excretion tests will be done at home prior to the initial
appointment and prior to the final appointment in week six. Specimen cups will be provided to
participants the day prior to samples being due and brought to office for storage, analyzation, and
data collection to be sent to the researcher. (See Appendix B) Extra cups and a detailed handout
about proper collection procedures, as well as in-office education on urine collection, will be
provided to limit missing or improperly collected urine. Office staff will monitor urine
collection, attendance/scheduling, and forward the information to researcher for analysis.
Informed Consent:
Ethical measures will be taken to adhere to the World Medical Association Declaration of
Helsinki on Ethical Principles for Medical Research involving Human Subjects.15 Ethical
considerations for this study include explicit explanation of potential risks and benefits of the
study prior to signing an informed consent form. Potential participants have the option of
declining and all participation throughout the study is voluntary. To remain ethical, the control
group will still receive the standard of care for CHF management. In addition to the researcher's
ethical considerations, a Research Ethics Committee Review will be conducted at MaineHealth,
as MaineHealth is the overseeing body of the offices that the study will be recruiting from.

ANTICIPATED RESULTS:
Anticipated findings of this study are that regular dietitian visits for nutrition education
and counseling will decrease sodium intake as seen through comparisons of the 24-hour urinary
sodium excretion values. An improvement in sodium intake from start to finish in the
intervention group is anticipated to be seen, as well as a significant difference in means of final
sodium intake between the intervention group and the control group.

DISCUSSION:
The proposed research would contribute to existing knowledge on this topic by showing a
need for diet education and dietitian visits for those newly diagnosed with CHF, leading possibly
then to an improvement of overall management and mortality rates for those with CHF.
Unfortunately, some limitations of this study that could affect results include confounding
variables, such as medications, previous knowledge on CHF and low sodium diet, motivation to
comply to recommendations, fluid intake, and other existing medical conditions. With those in
mind, research results could be applied in future practice and research studies as a means to
continue studying ways to lower CHF symptoms, costs, and mortality in patients and improve
current standards of care for CHF patients.

REFERENCES:
1. Heart failure statistics. Emory Healthcare Web site. https://www.emoryhealthcare.org/heart-
vascular/wellness/heart-failure-statistics.html. Updated 2009. Accessed May 11, 2019.
2. Heart failure fact sheet. Centers for Disease Control and Prevention Web site. https://
www.cdc.gov/dhdsp//data_statistics/fact_sheets/fs_heart_failure.htm. Updated January 8, 2019.
Accessed May 5, 2019.
3. Mahtani K, Heneghan C, Onakpoya I. Reduced sodium intake for heart failure. A systemic
review. JAMA Intern Med. 2018; 178(12): 1693-1700.
4. Sodium recommendations. American Heart Association Web site. https://www.heart.org.
Updated 2019. Accessed May 25, 2019.
5. Akhondzadeh K, Ghezeljeh TN, Haghani H. The effect of the education program on the
adherence intention to the dietary sodium restriction and the amount of sodium intake in patients
with Chronic Heart Failure. Iranian Red Crescent Med J. 2018; 20(51): e12925. doi: 10.5812/
ircmj.12925.
6. Abshire M, Xu J, Baptiste D, et al. Nutrition interventions in heart failure: A systemic review
of literature. J Card Fail. 2015; 21(12): 989-999.
7. Butler J, Papadimitriou L, Georgiopoulou V, Skopicki H, Dunbar S, Kalogeropoulos A.
Comparing sodium intake strategies in heart failure: Rationale and design of the PROHIBIT
sodium study. Circ Heart Fail. 2015; 8(3): 636-645.
8. Dunbar SB, Butts B, Reilly C, et al. A pilot test of an integrated self-care intervention for
persons with heart failure and concomitant diabetes. Nurs Outlook. 2014; 62(2): 97-111.
9. Seid MA, Abdela OA, Zeleke EG. Adherence to self-care recommendations and associated
factors among adult heart failure patients. From the patient's point of view. PloS ONE. 2019;
14(2): e0211768. doi: 10.1371/journal.pone.0211768.
10. Jacobsen KH. Introduction into Health Research Methods: A Practical Guide. 2nd Edition.
Burlington, MA: Jones and Bartlett Learning; 2017.
11. Zhang J, Yan L, Tang J. Estimating daily salt intake based on 24 hour urinary sodium
excretion in adults 18-69 years in Shandong, China. BMJ Open. 2014; 4: e005089. doi:10.1136/
bmjopen-2014-005089.
12. Aparicio A, Rodriguez-Rodriguez E, Cuadrado-Soto E, Navia B, Lopez-Sobaler A, Ortega R.
Estimation of salt intake assessed by urinary excretion of sodium over 24 h in Spanish subjects
aged 7-11 years. Eur J Nutr. 2017; 56: 171-178.
13. Xu J, Wang M, Chen Y, et al. Estimation of salt intake by 24-hour urinary sodium excretion:
A cross-sectional study in Yanti, China. BMC Public Health. 2014; 14: 136.
14. NCSS Statistical Analysis. https://www.ncss.com/software/ncss/comparing-means-in-ncss.
Updated 2019. Accessed June 2, 2019.
15. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research
Involving Human Subjects. www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-
principles-for-medical-research-involving-human-subjects. Updated July 9, 2018. Accessed June
2, 2019.
16. Sodium, 24-hour. LabCorp Web site. https://www.labcorp.com/test-menu/35046/sodium-24-
hour-urine. Updated 2019. Accessed June 16, 2019.
Appendix A
Informed Consent Form (Courtesy of eforms.com free fillable templates; Example provided
below. Also available with additional features with monthly subscription.)
Appendix B
Sample Lab Report for 24-hour Urinary Sodium Excretion Testing (LabCorp16)