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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03681925
Other study ID # STUDY00142818
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2019
Est. completion date March 6, 2020

Study information

Verified date March 2020
Source University of Kansas Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 95
Est. completion date March 6, 2020
Est. primary completion date March 6, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Health Knowledge, Attitudes, Practice

Intervention

Diagnostic Test:
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.

Locations

Country Name City State
United States Encompass Medical Group Kansas City Missouri
United States The University of Kansas Health System Family Medicine and Internal Medicine Clinics Kansas City Kansas
United States University of Kansas Medical Center Student Health Services Kansas City Kansas
United States University of Kansas Medical Center, Center for Physical Activity and Weight Management Kansas City Kansas
United States University of Kansas Medical Center Bariatric and Weight Loss Surgery Clinic Overland Park Kansas

Sponsors (1)

Lead Sponsor Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in BRFSS 2011 Fruit and Vegetable Module scores from baseline to one month post-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.
Secondary Change in Rapid Eating Assessment for Patients (REAP) score from baseline to one month post-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.
Secondary Patient view of patient-centeredness of the 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.
Secondary Patient-centeredness of the session between patient and dietitian 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
Secondary Readability of printed materials used by dietitians during interventions 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
Secondary Clearness of printed materials used by dietitians during interventions 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
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