- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03681925
Measuring Nutrition Literacy in Clinical Practice: Evaluating Effects Upon Providers and Patients
The Effects of Nutrition Literacy Assessment on Patient-Centered Nutrition Education Provided by Dietitians
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kansas
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Kansas City, Kansas, United States, 66160
- The University of Kansas Health System Family Medicine and Internal Medicine Clinics
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center Student Health Services
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center, Center for Physical Activity and Weight Management
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Overland Park, Kansas, United States, 66211
- University of Kansas Medical Center Bariatric and Weight Loss Surgery Clinic
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Missouri
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Kansas City, Missouri, United States, 64131
- Encompass Medical Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Nutrition literacy will be assessed with the Nutrition Literacy Assessment Instrument (NLit)
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Nutrition literacy will be measured prior to the patients' initial session with a dietitian, then again one month after the session.
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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.
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Dietary patterns will be assessed using the BRFSS 2011 Fruit and Vegetable Module.
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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.
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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.
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Dietary patterns will be assessed using the Rapid Eating Assessment for Patients (REAP)
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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.
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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.
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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
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Patients will complete the survey up to two months after they complete their session with a dietitian.
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Patient-centeredness of the session between patient and dietitian
Time Frame: One month post-session
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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.
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One month post-session
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Readability of printed materials used by dietitians during interventions
Time Frame: One month prior to first patient session with a dietitian
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Reading level of all printed materials will be assessed using the Flesch-Kincaid Readability score.
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One month prior to first patient session with a dietitian
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Clearness of printed materials used by dietitians during interventions
Time Frame: One month prior to first patient session with a dietitian
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Clearness of printed materials will be assessed using the Center for Disease Control Clear Communications Index
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One month prior to first patient session with a dietitian
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Collaborators and Investigators
Investigators
- Principal Investigator: Heather D Gibbs, PhD, University of Kansas Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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