- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03673267
Nutricity: A Pilot Study to Improve Parental Nutrition Literacy
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Nutricity
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parental Nutrition Literacy
Time Frame: 12 weeks
|
Measured by the Nutrition Literacy Assessment Instrument
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child Diet Quality
Time Frame: 12 weeks
|
Measured by Healthy Eating Index derived from 3 24 hour recalls obtained at baseline and end of study
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin Carotenoid Content
Time Frame: 12 weeks
|
Resonance Raman spectroscopy ("Veggie Meter," Longevity Link Corporation) uses gentle pressure applied to the pad of the fingertip to put in close contact with light to detect and measure carotenoid molecules in the blood.
Three, 10-45 second measurements are taken and averaged for the recorded score.
|
12 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Heather D Gibbs, PhD, RD, University of Kansas Medical Center
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
Keywords
Other Study ID Numbers
- 142565
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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