Dietary HabitsNCT03673267
Nutricity: A Pilot Study to Improve Parental Nutrition Literacy
A study testing Nutricity in people with Dietary Habits and Dietary Modification, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The aim of this study is to engage parents and their young children (1-5 years of age) using the mobile intervention, Nutricity. Study goals are to increase parental nutrition literacy and improve eating habits of children. 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, Dietary Modification, Literacy
- What is being tested?
- Nutricity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 12 Aug 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents must be English speaking and must 1) Identify as primary food decision-maker for the home, 2) Have internet access at home and 3) Must have a device for accessing the internet. Smartphones, owned by ~75-92% of the target population, are adequate to satisfy the latter two criteria.
Who cannot join
- 1) Overt cognitive or psychiatric illness, 2) Visual impairments that preclude reading survey instruments or using a tablet, 3) Child illness requiring a highly restrictive diet, such as renal disease, celiac disease, etc., 4) Planning to travel internationally during the study, 5) child is a foster child or ward of the state.
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 aim of this study is to engage parents and their young children (1-5 years of age) using the mobile intervention, Nutricity. Study goals are to increase parental nutrition literacy and improve eating habits of children.
Read the detailed description
Nutricity website: Nutricity is a mobile website that uses communication techniques that break down each section to teach parents and children the nutrition information. The site addresses five components of nutrition literacy:
- ability to comprehend nutrition text
- eating foods in the right portions
- using food labels to make nutrition decisions
- grouping foods into like categories
- choosing between similar foods (consumer skills)
Participants will have three months of free access to Nutricity during this study. They will also be encouraged to set one nutrition goal per week and encouraged to use Nutricity to help attain that goal. Participants will send weekly goals through text message to a number provided by the research team.
There are three phases to this study:
Baseline: Participants will be asked to come to the clinic or research lab 1 time for procedures and assessments that will help the investigator assess nutrition literacy and eligibility.
Nutricity: During this phase participants will use their smartphone to access the Nutricity website to potentially increase nutrition literacy and set nutrition goals.
This phase will last approximately 3 months.
End Study: Participants will be asked to come to the research lab 1 time to perform the same procedures and assessments completed in the baseline visit.
Assessments include:
Height/Weight: Parent/guardian and child will have their height and weight measured.
Demographics: questionnaires will ask for information such as name, date of birth and race.
Nutrition Questionnaires: Participants will complete 1 questionnaire on 2 occasions to assess nutrition literacy using the Nutrition Literacy Assessment Instrument (NLit). The NLit measures nutrition literacy and is comprised of six domains:
- nutrition and health
- energy sources in food
- household food measurement
- food labels/numbers
- food groups
- consumer skills
Parents/Guardians will also be asked about fruit, vegetable, fat, and fiber intake.
24-hour Recall: Parents will be asked questions about a child's current diet over the previous 24 hours. For children who eat meals at school or daycare, researchers will provide forms to the child's teacher or daycare provider to record the meals they eat while there. Two additional recalls will be done during the study that will be done with researchers over the phone.
Resonance Raman Spectroscopy (Veggie Meter): During this assessment, the veggie meter will apply gentle pressure to the pad of a child's fingertip to put it in close contact with light, to detect and measure carotenoid in the blood. Carotenoids are the yellow, orange, and red colors that are produced in plants, such as tomatoes. Three, 10-45 second measurements are taken and averaged for the recorded score.
Exit Survey: Upon completion of the study, participants will complete one questionnaire to provide the researchers feedback on their experience in the study.
- Being tested
- Nutricity
- Keywords
- health literacy, nutrition literacy, parenting
- Medical subject headings
- Feeding Behavior, Literacy, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutricityBehavioural
Participants will use their smartphone or web-accessing device to access the Nutricity website to potentially increase nutrition literacy and set nutrition goals. Participants will have their own user name and password to access the site. Access to Nutricity will last approximately 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Nutricity | Experimental | Not described Receives: Behavioral: Nutricity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Nutrition Literacy
Measured by the Nutrition Literacy Assessment Instrument
Measured: 12 weeks
Secondary outcomes (1)
Child Diet Quality
Measured by Healthy Eating Index derived from 3 24 hour recalls obtained at baseline and end of study
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start15 Oct 2018
- Primary completion12 Aug 2019
- Study completion12 Aug 2019
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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, RD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673267
- Sponsor's protocol ID
- 142565
- Status last verified
- Sep 2019
- First submitted
- 28 Aug 2018
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutricity: A Pilot Study to Improve Parental Nutrition Literacy
- ClinicalTrials.gov ID
- NCT03673267
- Acronym / sponsor ID
- 142565
- Keywords
- health literacy, nutrition literacy, parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 12 Aug 2019 (actual)
- First posted
- 17 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.
The aim of this study is to engage parents and their young children (1-5 years of age) using the mobile intervention, Nutricity. Study goals are to increase parental nutrition literacy and improve eating habits of children.
Detailed description
Nutricity website: Nutricity is a mobile website that uses communication techniques that break down each section to teach parents and children the nutrition information. The site addresses five components of nutrition literacy:
- ability to comprehend nutrition text
- eating foods in the right portions
- using food labels to make nutrition decisions
- grouping foods into like categories
- choosing between similar foods (consumer skills)
Participants will have three months of free access to Nutricity during this study. They will also be encouraged to set one nutrition goal per week and encouraged to use Nutricity to help attain that goal. Participants will send weekly goals through text message to a number provided by the research team.
There are three phases to this study:
Baseline: Participants will be asked to come to the clinic or research lab 1 time for procedures and assessments that will help the investigator assess nutrition literacy and eligibility.
Nutricity: During this phase participants will use their smartphone to access the Nutricity website to potentially increase nutrition literacy and set nutrition goals.
This phase will last approximately 3 months.
End Study: Participants will be asked to come to the research lab 1 time to perform the same procedures and assessments completed in the baseline visit.
Assessments include:
Height/Weight: Parent/guardian and child will have their height and weight measured.
Demographics: questionnaires will ask for information such as name, date of birth and race.
Nutrition Questionnaires: Participants will complete 1 questionnaire on 2 occasions to assess nutrition literacy using the Nutrition Literacy Assessment Instrument (NLit). The NLit measures nutrition literacy and is comprised of six domains:
- nutrition and health
- energy sources in food
- household food measurement
- food labels/numbers
- food groups
- consumer skills
Parents/Guardians will also be asked about fruit, vegetable, fat, and fiber intake.
24-hour Recall: Parents will be asked questions about a child's current diet over the previous 24 hours. For children who eat meals at school or daycare, researchers will provide forms to the child's teacher or daycare provider to record the meals they eat while there. Two additional recalls will be done during the study that will be done with researchers over the phone.
Resonance Raman Spectroscopy (Veggie Meter): During this assessment, the veggie meter will apply gentle pressure to the pad of a child's fingertip to put it in close contact with light, to detect and measure carotenoid in the blood. Carotenoids are the yellow, orange, and red colors that are produced in plants, such as tomatoes. Three, 10-45 second measurements are taken and averaged for the recorded score.
Exit Survey: Upon completion of the study, participants will complete one questionnaire to provide the researchers feedback on their experience in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutricity | Experimental | Behavioral: Nutricity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parents must be English speaking and must 1) Identify as primary food decision-maker for the home, 2) Have internet access at home and 3) Must have a device for accessing the internet. Smartphones, owned by ~75-92% of the target population, are adequate to satisfy the latter two criteria.
Key exclusion criteria (1 listed)
- 1) Overt cognitive or psychiatric illness, 2) Visual impairments that preclude reading survey instruments or using a tablet, 3) Child illness requiring a highly restrictive diet, such as renal disease, celiac disease, etc., 4) Planning to travel internationally during the study, 5) child is a foster child or ward of the state.
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 |
|---|---|---|
| NutricityParticipants will use their smartphone or web-accessing device to access the Nutricity website to potentially increase nutrition literacy and set nutrition goals. Participants will have their own user name and password to access the site. Access to Nutricity will last approximately 3 months. | Behavioural | Nutricity |
Primary outcome
Parental Nutrition Literacy
Time frame: 12 weeks
Measured by the Nutrition Literacy Assessment Instrument
1 secondary outcome
Child Diet Quality
Time frame: 12 weeks
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 4 Sep 2019.
- 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, RD 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?
A study testing Nutricity in people with Dietary Habits and Dietary Modification, 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 1 inclusion and 1 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 4 Sep 2019. 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?
Parental Nutrition Literacy (time frame: 12 weeks). 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 4 Sep 2019.