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

NCT03681925 | Completed DMC

• 1 other identifier: STUDY00142818
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 5

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.

Conditions

Health Knowledge, Attitudes, Practice

Keywords

Patient-centered care; Dietitian; Nutrition literacy

Outcome Measures

Primary Outcomes (1)

• Change in Nutrition Literacy Assessment Instrument (NLit) score from baseline to post-session.

  Nutrition literacy will be assessed with the Nutrition Literacy Assessment Instrument (NLit)

  Nutrition literacy will be measured prior to the patients' initial session with a dietitian, then again one month after the session.

Secondary Outcomes (6)

• Change in BRFSS 2011 Fruit and Vegetable Module scores from baseline to one month post-session.

  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.

• Change in Rapid Eating Assessment for Patients (REAP) score from baseline to one month post-session

  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.

• Patient view of patient-centeredness of the session with a dietitian

  Patients will complete the survey up to two months after they complete their session with a dietitian.

• Patient-centeredness of the session between patient and dietitian

  One month post-session

• Readability of printed materials used by dietitians during interventions

  One month prior to first patient session with a dietitian

Study Arms (2)

Intervention

EXPERIMENTAL

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)

Control

NO INTERVENTION

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.

Interventions

Nutrition Literacy Assessment Instrument (NLit) DIAGNOSTIC_TEST

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (5)

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

Kansas City, Kansas, 66160, United States

Location

University of Kansas Medical Center Student Health Services

Kansas City, Kansas, 66160, United States

Location

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

Kansas City, Kansas, 66160, United States

Location

University of Kansas Medical Center Bariatric and Weight Loss Surgery Clinic

Overland Park, Kansas, 66211, United States

Location

Encompass Medical Group

Kansas City, Missouri, 64131, United States

Location

Related Publications (1)

• 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.

  PMID: 29246567 BACKGROUND

MeSH Terms

Conditions

Behavior

Study Officials

• Heather D Gibbs, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient participants will be unaware of which arm their dietitian has been randomized to.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 6 dietitians will be randomized in a 2:1 intervention:control fashion. Each dietitian will recruit 19 patient participants, for 114 total patient participants.

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: September 24, 2018
• Study Start: January 15, 2019
• Primary Completion: March 6, 2020
• Study Completion: March 6, 2020
• Last Updated: March 20, 2020

Record last verified: 2020-03

Locations

US (5)