Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT03673267
Status:
COMPLETED
Last Update Posted:
2019-09-04
First Post:
2018-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nutricity: A Pilot Study to Improve Parental Nutrition Literacy
Sponsor:
University of Kansas Medical Center
Organization:
Study Overview
Official Title:
Nutricity: A Pilot Study to Improve Parental Nutrition Literacy
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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:
1. ability to comprehend nutrition text
2. eating foods in the right portions
3. using food labels to make nutrition decisions
4. grouping foods into like categories
5. 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:
1. nutrition and health
2. energy sources in food
3. household food measurement
4. food labels/numbers
5. food groups
6. 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.
1. ability to comprehend nutrition text
2. eating foods in the right portions
3. using food labels to make nutrition decisions
4. grouping foods into like categories
5. 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:
1. nutrition and health
2. energy sources in food
3. household food measurement
4. food labels/numbers
5. food groups
6. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: