Health Knowledge, Attitudes, PracticeNCT03681925
Measuring Nutrition Literacy in Clinical Practice: Evaluating Effects Upon Providers and Patients
A study testing Nutrition Literacy Assessment Instrument (NLit) in people with Health Knowledge, Attitudes, Practice, run by University of Kansas Medical Center at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Knowledge, Attitudes, Practice
- What is being tested?
- Nutrition Literacy Assessment Instrument (NLit)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Jan 2019to 6 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects must be at least 18 years old
- subjects must be able to read English
- subjects must be scheduled with a participating dietitian
Who cannot join
- subjects with cognitive disabilities or overt mental illnesses
- subjects with vision issues severe enough to disrupt reading of the NLit.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The University of Kansas Health System Family Medicine and Internal Medicine Clinics
Kansas City, Kansas, 66160
University of Kansas Medical Center Student Health Services
Kansas City, Kansas, 66160
University of Kansas Medical Center, Center for Physical Activity and Weight Management
Kansas City, Kansas, 66160
Encompass Medical Group
Kansas City, Missouri, 64131
University of Kansas Medical Center Bariatric and Weight Loss Surgery Clinic
Overland Park, Kansas, 66211
About this study
Official title: 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.
Read the 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.
- Conditions
- Health Knowledge, Attitudes, Practice
- Being tested
- Nutrition Literacy Assessment Instrument (NLit)
- Keywords
- Patient-centered care, Dietitian, Nutrition literacy
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Diagnostic Test: Nutrition Literacy Assessment Instrument (NLit) |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Nutrition literacy will be measured prior to the patients' initial session with a dietitian, then again one month after the session.
Secondary outcomes (6)
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.
Measured: 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
Dietary patterns will be assessed using the Rapid Eating Assessment for Patients (REAP)
Measured: 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
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
Measured: 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
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.
Measured: One month post-session
Readability of printed materials used by dietitians during interventions
Reading level of all printed materials will be assessed using the Flesch-Kincaid Readability score.
Measured: One month prior to first patient session with a dietitian
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
Measured: One month prior to first patient session with a dietitian
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start15 Jan 2019
- Primary completion6 Mar 2020
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 6 dietitians will be randomized in a 2:1 intervention:control fashion. Each dietitian will recruit 19 patient participants, for 114 total patient participants.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather D Gibbs, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681925
- Sponsor's protocol ID
- STUDY00142818
- Status last verified
- Mar 2020
- First submitted
- 14 Sep 2018
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29246567
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Nutrition Literacy Assessment on Patient-Centered Nutrition Education Provided by Dietitians
- ClinicalTrials.gov ID
- NCT03681925
- Acronym / sponsor ID
- STUDY00142818
- Conditions
- Health Knowledge, Attitudes, Practice
- Keywords
- Patient-centered care, Dietitian, Nutrition literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 24 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 6 dietitians will be randomized in a 2:1 intervention:control fashion. Each dietitian will recruit 19 patient participants, for 114 total patient participants.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Diagnostic Test: Nutrition Literacy Assessment Instrument (NLit)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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subjects must be at least 18 years old
- subjects must be able to read English
- subjects must be scheduled with a participating dietitian
Key exclusion criteria (2 listed)
- subjects with cognitive disabilities or overt mental illnesses
- subjects with vision issues severe enough to disrupt reading of the NLit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Intervention |
Primary outcome
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)
6 secondary outcomes
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.
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.
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-centeredness of the session between patient and dietitian
Time frame: 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
Clearness of printed materials used by dietitians during interventions
Time frame: One month prior to first patient session with a dietitian
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
- Background: PubMed 29246567Gibbs 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather D Gibbs, PhD principal investigator
University of Kansas Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Literacy Assessment Instrument (NLit) in people with Health Knowledge, Attitudes, Practice, run by University of Kansas Medical Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03681925, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.