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

NCT ID: NCT03681925

Last Updated: 2020-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2020-03-06

Brief Summary

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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

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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.

Conditions

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Health Knowledge, Attitudes, Practice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants
Patient participants will be unaware of which arm their dietitian has been randomized to.

Study Groups

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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.

Group Type EXPERIMENTAL

Nutrition Literacy Assessment Instrument (NLit)

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heather D Gibbs, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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

Kansas City, Kansas, United States

Site Status

University of Kansas Medical Center Student Health Services

Kansas City, Kansas, United States

Site Status

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

Kansas City, Kansas, United States

Site Status

University of Kansas Medical Center Bariatric and Weight Loss Surgery Clinic

Overland Park, Kansas, United States

Site Status

Encompass Medical Group

Kansas City, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 29246567 (View on PubMed)

Other Identifiers

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STUDY00142818

Identifier Type: -

Identifier Source: org_study_id

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