Dietary HabitsNCT02920099
Adaptation and Validation of a Nutrition Literacy Assessment Instrument
An observational study of Dietary Habits, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to develop a tool to help researchers better understand what diet information people know and what skills they use to make diet choices. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits
- What is being tested?
- Nutrition Literacy Assessment Instrument (NLAI)
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jun 2016
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: University of Kansas Medical Center (KUMC) students
Who may be able to join
- Able to speak and read English
- Have 1 or more of the following diseases: diabetes, hyperlipidemia, hypertension, and/or overweight/obesity
Who cannot join
- Visual acuity insufficient to read the testing instrument
- Cognitive impairment
- Weight > 500 pounds
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to develop a tool to help researchers better understand what diet information people know and what skills they use to make diet choices.
- Conditions
- Dietary Habits
- Being tested
- Nutrition Literacy Assessment Instrument (NLAI)
- Keywords
- Nutrition literacy
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition Literacy Assessment Instrument (NLAI)Other
Assessment tool which combines elements of different nutrition literacy tools.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Literacy | Participants will be asked to completed the Nutrition Literacy Assessment Instrument (NLAI). Receives: Other: Nutrition Literacy Assessment Instrument (NLAI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nutrition Literacy Assessment Instrument (NLAI) responses
Participants will complete the NLAI two times over the course of one month. Responses will help shape adaptions to the tool for use in a primary care population.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startJun 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary HabitsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Heather Gibbs, PhD, RD, LD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920099
- Sponsor's protocol ID
- 13805
- Other IDs
- R03HD081730
- Status last verified
- Sep 2016
- First submitted
- 27 Sep 2016
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Validation of a Nutrition Literacy Assessment Instrument
- ClinicalTrials.gov ID
- NCT02920099
- Acronym / sponsor ID
- 13805
- Conditions
- Dietary Habits
- Keywords
- Nutrition literacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jun 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Sep 2016 (estimated)
- 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.
The purpose of this study is to develop a tool to help researchers better understand what diet information people know and what skills they use to make diet choices.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutrition Literacy | – | Other: Nutrition Literacy Assessment Instrument (NLAI)Participants will be asked to completed the Nutrition Literacy Assessment Instrument (NLAI). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- University of Kansas Medical Center (KUMC) students
Key inclusion criteria (2 listed)
- Able to speak and read English
- Have 1 or more of the following diseases: diabetes, hyperlipidemia, hypertension, and/or overweight/obesity
Key exclusion criteria (3 listed)
- Visual acuity insufficient to read the testing instrument
- Cognitive impairment
- Weight > 500 pounds
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 (NLAI)Assessment tool which combines elements of different nutrition literacy tools. | Other | Nutrition Literacy |
Primary outcome
Change in Nutrition Literacy Assessment Instrument (NLAI) responses
Time frame: 1 month
Participants will complete the NLAI two times over the course of one month. Responses will help shape adaptions to the tool for use in a primary care population.
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 30 Sep 2016.
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Dietary Habits
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 Gibbs, PhD, RD, LD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dietary Habits, run by University of Kansas Medical Center at 1 site 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 2 inclusion and 3 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 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (NLAI) responses (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2016.