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NCT Number: NCT03681925

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Kansas Health System Family Medicine and Internal Medicine Clinics, Kansas City, Kansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 24, 2018
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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