Clinical trial NCT03681925: Measuring Nutrition Literacy in Clinical Practice: Evaluating Effects Upon Providers and Patients
Official title: The Effects of Nutrition Literacy Assessment on Patient-Centered Nutrition Education Provided by Dietitians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Keywords: Patient-centered care
Dietitian
Nutrition literacy
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SCREENING

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in Nutrition Literacy Assessment Instrument (NLit) score from baseline to post-session.
timeFrame: Nutrition literacy will be measured prior to the patients' initial session with a dietitian, then again one month after the session.
Secondary outcomes:
measure: Change in BRFSS 2011 Fruit and Vegetable Module scores from baseline to one month post-session.
timeFrame: 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.
measure: Change in Rapid Eating Assessment for Patients (REAP) score from baseline to one month post-session
timeFrame: 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.
measure: Patient view of patient-centeredness of the session with a dietitian
timeFrame: Patients will complete the survey up to two months after they complete their session with a dietitian.
measure: Patient-centeredness of the session between patient and dietitian
timeFrame: One month post-session
measure: Readability of printed materials used by dietitians during interventions
timeFrame: One month prior to first patient session with a dietitian
measure: Clearness of printed materials used by dietitians during interventions
timeFrame: One month prior to first patient session with a dietitian
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The University of Kansas Health System Family Medicine and Internal Medicine Clinics
state: Kansas
city: Kansas City
country: United States
facility: University of Kansas Medical Center Student Health Services
state: Kansas
city: Kansas City
country: United States
facility: University of Kansas Medical Center, Center for Physical Activity and Weight Management
state: Kansas
city: Overland Park
country: United States
facility: University of Kansas Medical Center Bariatric and Weight Loss Surgery Clinic
state: Kansas
city: Kansas City
country: United States
facility: Encompass Medical Group
state: Missouri
Study officials:
affiliation: University of Kansas Medical Center
name: Heather D Gibbs, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.