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

March 19, 2020 updated by: University of Kansas Medical Center

The Effects of Nutrition Literacy Assessment on Patient-Centered Nutrition Education Provided by Dietitians

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kansas
      • Kansas City, Kansas, United States, 66160
        • 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
      • Overland Park, Kansas, United States, 66211
        • University of Kansas Medical Center Bariatric and Weight Loss Surgery Clinic
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Encompass Medical Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Nutrition literacy will be measured prior to the patients' initial session with a dietitian, then again one month after the session.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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)
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
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
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
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.
One month post-session
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.
One month prior to first patient session with a dietitian
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
One month prior to first patient session with a dietitian

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 15, 2019

Primary Completion (ACTUAL)

March 6, 2020

Study Completion (ACTUAL)

March 6, 2020

Study Registration Dates

First Submitted

September 14, 2018

First Submitted That Met QC Criteria

September 20, 2018

First Posted (ACTUAL)

September 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 20, 2020

Last Update Submitted That Met QC Criteria

March 19, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00142818

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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