Measuring Nutrition Literacy in Clinical Practice: Evaluating Effects Upon Providers and Patients

• ClinicalTrials.gov Identifier: NCT03681925
• Recruitment Status: Completed
• First Posted: September 24, 2018
• Last Update Posted: March 20, 2020
• Sponsor: University of Kansas Medical Center
• Information provided by (Responsible Party): University of Kansas Medical Center

Study Description

Brief Summary:

This study evaluates the effects of assessing patient nutrition literacy prior to an initial session with an outpatient dietitian on the patient-centeredness of the session. We will randomize 6 dietitians, 4 of whom will have access to their participating patients' nutrition literacy scores. These dietitians will use this information to better inform their interventions, and hopefully improve their patients' nutrition literacy as a result.

Condition or disease	Intervention/treatment	Phase
Health Knowledge, Attitudes, Practice	Diagnostic Test: Nutrition Literacy Assessment Instrument (NLit)	Not Applicable

Detailed Description:

Nutrition Literacy Assessment Tool (NLit): a validated, 64-question survey that assesses nutrition literacy across 6 subscales:

• Nutrition and Health
• Energy Sources in Food
• Household Food Measurement
• Food Label and Numeracy
• Food Groups
• Consumer Skills

Dietitians who work within 6 different outpatient clinics (1 dietitian per clinic) will be recruited to the study; each dietitian will recruit 19 patients from their clinic. All patient participants will take the NLit survey prior to an initial visit with their dietitian. Dietitians randomized to the intervention arm (n=4) will have access to their participating patients' NLit results, and tailor their intervention to the patient's nutrition literacy weaknesses. Dietitians randomized to the control group (n=2) will not have access to their participating patients' NLit scores, and will provide the same standard-of-care intervention usually provided.

All participating patients will then re-take the NLit a month after their initial session with their dietitian, and we will examine the results to see if a) nutrition literacy improved within groups, and b) if the patients of the intervention dietitians showed more improvement in nutrition literacy than their counterparts being treated by the control dietitians.

We will also collect dietary pattern information from participating patients before their initial session with their dietitian, and again one month after their initial session with their dietitian. We will examine the results to see if a) dietary patterns improve with increased nutrition literacy, and b) if the dietary patterns of patients in the intervention group improve more than patients in the control group.

Finally, we will collect survey information from patients pertaining to the perceived patient-centeredness of the session with their dietitian. We will also collect audio recordings of the sessions between patients and dietitians, which will be analyzed for patient-centeredness. We will also analyze readability and clearness of printed materials used by dietitians during their interventions with patients.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 95 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 6 dietitians will be randomized in a 2:1 intervention:control fashion. Each dietitian will recruit 19 patient participants, for 114 total patient participants.
• Masking: Single (Participant)
• Masking Description: Patient participants will be unaware of which arm their dietitian has been randomized to.
• Primary Purpose: Screening
• Official Title: The Effects of Nutrition Literacy Assessment on Patient-Centered Nutrition Education Provided by Dietitians
• Actual Study Start Date: January 15, 2019
• Actual Primary Completion Date: March 6, 2020
• Actual Study Completion Date: March 6, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; Dietitians randomized to the intervention arm will have access to their participating patients' Nutrition Literacy Assessment Instrument (NLit) scores, and base their intervention on these results.	Diagnostic Test: Nutrition Literacy Assessment Instrument (NLit); The NLit is a 64-question survey broken into 6 subscales. each subscale examines a different aspect of nutrition literacy (Nutrition and Health, Energy Sources in Food, Household Food Measurement, Food Label and Numeracy, Food Groups, and Consumer Skills). Global and subscale NLit scores will be generated for each participating patient.
No Intervention: Control; Dietitians randomized to the control arm will not have access to their participating patients' Nutrition Literacy Assessment Instrument (NLit) scores, and will provide the standard-of-care intervention for their patients.

Outcome Measures

Primary Outcome Measures :

1. Change in Nutrition Literacy Assessment Instrument (NLit) score from baseline to post-session. [ Time Frame: Nutrition literacy will be measured prior to the patients' initial session with a dietitian, then again one month after the session. ]
   Nutrition literacy will be assessed with the Nutrition Literacy Assessment Instrument (NLit)

Secondary Outcome Measures :

1. Change in BRFSS 2011 Fruit and Vegetable Module scores from baseline to one month post-session. [ Time Frame: BRFSS 2011 Fruit and Vegetable Module scores will be measured prior to the patients' initial session with a dietitian, then again one month after the session. ]
   Dietary patterns will be assessed using the BRFSS 2011 Fruit and Vegetable Module.
2. Change in Rapid Eating Assessment for Patients (REAP) score from baseline to one month post-session [ Time Frame: BRFSS 2011 Fruit and Vegetable Module scores will be measured prior to the patients' initial session with a dietitian, then again one month after the session. ]
   Dietary patterns will be assessed using the Rapid Eating Assessment for Patients (REAP)
3. Patient view of patient-centeredness of the session with a dietitian [ Time Frame: Patients will complete the survey up to two months after they complete their session with a dietitian. ]
   Patient view of patient-centeredness of the session will be assessed using a modified version of the Consumer Assessment of Healthcare Providers and Systems-Clinician and Group Survey (CAHPS), v.3.0
4. Patient-centeredness of the session between patient and dietitian [ Time Frame: One month post-session ]
   Patient-centeredness of the session between patient and dietitian will be assessed using the Teach back Loop Score, a validated tool used to examine the use of teach back, an essential part of patient-centered care.
5. Readability of printed materials used by dietitians during interventions [ Time Frame: One month prior to first patient session with a dietitian ]
   Reading level of all printed materials will be assessed using the Flesch-Kincaid Readability score.
6. Clearness of printed materials used by dietitians during interventions [ Time Frame: One month prior to first patient session with a dietitian ]
   Clearness of printed materials will be assessed using the Center for Disease Control Clear Communications Index

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• subjects must be at least 18 years old
• subjects must be able to read English
• subjects must be scheduled with a participating dietitian

Exclusion Criteria:

• subjects with cognitive disabilities or overt mental illnesses
• subjects with vision issues severe enough to disrupt reading of the NLit.

Contacts and Locations

Locations

United States, Kansas

The University of Kansas Health System Family Medicine and Internal Medicine Clinics

Kansas City, Kansas, United States, 66160

University of Kansas Medical Center Student Health Services

Kansas City, Kansas, United States, 66160

University of Kansas Medical Center, Center for Physical Activity and Weight Management

Kansas City, Kansas, United States, 66160

University of Kansas Medical Center Bariatric and Weight Loss Surgery Clinic

Overland Park, Kansas, United States, 66211

United States, Missouri

Encompass Medical Group

Kansas City, Missouri, United States, 64131

Sponsors and Collaborators

University of Kansas Medical Center

Investigators

• Principal Investigator: Heather D Gibbs, PhD; University of Kansas Medical Center

More Information

Publications:

Gibbs HD, Ellerbeck EF, Gajewski B, Zhang C, Sullivan DK. The Nutrition Literacy Assessment Instrument is a Valid and Reliable Measure of Nutrition Literacy in Adults with Chronic Disease. J Nutr Educ Behav. 2018 Mar;50(3):247-257.e1. doi: 10.1016/j.jneb.2017.10.008. Epub 2017 Dec 12.

• Responsible Party: University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT03681925
• Other Study ID Numbers: STUDY00142818
• First Posted: September 24, 2018
• Last Update Posted: March 20, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Kansas Medical Center:

Patient-centered care; Dietitian; Nutrition literacy