Children, OnlyNCT05730530
Fruit and Vegetable Intake in Preschoolers
A study testing Nutrition education curriculum in people with Children, Only and Nutrition, Healthy, run by University of Virginia at 1 site in United States.
Trial summary
The goal of this randomized controlled trial is to examine fruit and vegetable consumption in preschoolers following a nutrition education curriculum. The main questions it aims to answer is: 1. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Children, Only, Nutrition, Healthy
- What is being tested?
- Nutrition education curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2023to 1 Aug 2023
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Typically-developing children with no food allergies and not taking medication
Who cannot join
- Food Allergies
- Taking medications
- Developmental delays
Trial locations and contacts
1 site in 1 country.
United States1 site
Westminster Child Care Center
Charlottesville, Virginia, 22903
About this study
Official title: Nutrition Education Intervention to Improve Fruit and Vegetable Consumption in Preschoolers
The goal of this randomized controlled trial is to examine fruit and vegetable consumption in preschoolers following a nutrition education curriculum. The main questions it aims to answer is:
- Is this intervention consisting of nutrition education and taste-test activities able to improve fruit and vegetable consumption in preschoolers during their usual lunch meal?
- Is the improvement of fruit and vegetable consumption sustained for at least 6 weeks after completion of the intervention?
Participants in the intervention classroom will partake in 3 nutrition education sessions per week during the 6-week-long curriculum. Researchers will compare this to changes in fruit and vegetable intake of the children in the control classroom, who will undergo identical measurements, but will not participate in the curriculum.
Read the detailed description
Fruit and vegetable consumption in preschoolers in the United States is very low, with the majority of children not meeting the national recommendations. However, there is a lack of data indicating effective strategies to increase preschooler's fruit and vegetable intake and whether socio-demographic and eating behavior-related child characteristics (child eating behavior and relationship with food) may predict fruit and vegetable consumption in preschoolers as well as their response to the intervention. This information is important for researchers because it may allow for more effective development of future interventions that consider these potential external influences. There is also a lack of evidence-based interventions that are based on theoretical behavior change frameworks and the associated behavior change techniques. Furthermore, studies lack a long enough follow-up to measure whether any possibly observed behavior change (more fruits and vegetables consumed) in the preschoolers is maintained following the cessation of the intervention.
While fruit and vegetable consumption is associated with lower blood pressure in adults, little is known about this relationship in children. This will be examined in our study to determine if there is an association between blood pressure and fruit and vegetable intake at baseline and whether this association changes following the intervention.
To control for differences in energy needs, it is important to control for children's BMI-for-age percentile, which is calculated using their age, height, and weight. This is necessary because children who have higher BMI percentiles typically require more total energy consumption, which may influence fruit and vegetable consumption. Additionally, previous studies have observed that children with greater BMI percentile are less likely to eat adequate amounts of fruits and vegetables. However, this has not been measured in an interventional manner, and therefore it is unknown whether these associations are omnipotent, and whether they remain following a fruit and vegetable intervention. Therefore, our study will examine these relationships in a small sample of preschoolers to either support or contradict these previous observations.
In addition to measuring fruit and vegetable intake, it is also important to measure physical activity levels as a control variable for total energy requirements, as changes in physical activity levels may confound changes in dietary intake, including intake of fruits and vegetables. This is especially true of interventions that span different seasons (ie. winter and spring), as these may also influence physical activity levels and, subsequently, energy requirements. Secondarily, previous research has established an association between fruit and vegetable intake and both physical activity levels and screen time in children and adults. However, no studies have explored this relationship in preschool-aged children. Additionally, the evidence of the relationship between these two variables is limited to cross-sectional data; it is unknown whether an increase in one would influence the other. We plan to examine this in a small sample of preschoolers in an interventional setting.
Therefore, the purpose of this research is to determine whether such an intervention is able to increase and maintain fruit and vegetable intake during lunch in a sample of preschoolers, controlling for age, BMI percentile, and activity level. Additional aims are 1) to explore the relationship between fruit and vegetable intake and blood pressure, 2) examine the relationship between FV intake and physical activity levels in this sample of preschoolers, and 3) examine how BMI-percentile and socio-demographic and child- and parent-related eating-related characteristics are associated with fruit and vegetable intake. We plan to publish our findings in a scientific journal to contribute to the advancement of knowledge regarding interventions to improve fruit and vegetable intake in preschoolers, as information is evidently needed in this topic.
- Conditions
- Children, Only, Nutrition, Healthy
- Being tested
- Nutrition education curriculum
- Keywords
- Preschool, Fruits and vegetables, Nutrition education, Behavior change theory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition education curriculumBehavioural
This intervention consists of a 6-week-long nutrition education curriculum aimed at improving fruit and vegetable acceptance and consumption. Sessions will occur within the classroom 3 times per week for 6 weeks. Each week, the sessions will consist of 2 days of teaching activities and 1 day of taste-test activities designed for children to guess various common fruits and vegetables, assemble recipes including 2-4 different fruits and vegetables, and then taste the foods. These activities will be conducted in a full-classroom group setting.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Classroom assigned to receive the 6-week long nutrition education curriculum Receives: Behavioral: Nutrition education curriculum |
| Control | No intervention | Classroom assigned to receive no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fruit and vegetable intake post-intervention
Fruits and vegetables consumed during a typical lunch meal, measured using plate-waste weighing method, which involves subtracting the grams of food leftover from the grams of food served to estimate the grams of food consumed. All weighing of the foods will be done in the Diet and Nutrition Lab before and after going to the childcare center. This will be measured on three consecutive days during each of the measurement weeks below.
Measured: Change in fruit and vegetable intake from baseline (week 0) to post-intervention (week 7)
Fruit and vegetable intake at follow-up
Fruits and vegetables consumed during a typical lunch meal, measured using plate-waste weighing method, which involves subtracting the grams of food leftover from the grams of food served to estimate the grams of food consumed. All weighing of the foods will be done in the Diet and Nutrition Lab before and after going to the childcare center. This will be measured on three consecutive days during each of the measurement weeks below.
Measured: Change in fruit and vegetable intake from baseline (week 0) to follow-up (week 14)
Skin carotenoid levels post-intervention
Children's fruit and vegetable intake will be confirmed using a measure of skin carotenoid levels. This will be measured using a VeggieMeter device, which utilizes non-invasive reflection spectroscopy to estimate the amount of dietary carotenoids deposited into the skin. Children will be asked to wash their hands and then place their right pointer finger on a small lens for approximately 15 seconds. This will be measured immediately following the 3 measured lunch meals at the 3 time points.
Measured: Change in fruit and vegetable intake from baseline (week 0) to post-intervention (week 7)
Skin carotenoid levels at follow-up
Children's fruit and vegetable intake will be confirmed using a measure of skin carotenoid levels. This will be measured using a VeggieMeter device, which utilizes non-invasive reflection spectroscopy to estimate the amount of dietary carotenoids deposited into the skin. Children will be asked to wash their hands and then place their right pointer finger on a small lens for approximately 15 seconds. This will be measured immediately following the 3 measured lunch meals at the 3 time points.
Measured: Change in fruit and vegetable intake from baseline (week 0) to follow-up (week 14)
Secondary outcomes (16)
Systolic and diastolic blood pressure, baseline
Systolic and diastolic blood pressure will be measured in duplicate using an automatic monitor fitted with a child-sized cuff. These blood pressure measures will also be converted to sex-, height-, and age-based blood pressure percentiles using an online calculator developed by Baylor College of Medicine. This will be measured on three consecutive days during each of the measurement weeks below.
Measured: Baseline (week 0)
Systolic and diastolic blood pressure, post-intervention
Systolic and diastolic blood pressure will be measured in duplicate using an automatic monitor fitted with a child-sized cuff. These blood pressure measures will also be converted to sex-, height-, and age-based blood pressure percentiles using an online calculator developed by Baylor College of Medicine. This will be measured on three consecutive days during each of the measurement weeks below.
Measured: post-intervention (week 7)
Systolic and diastolic blood pressure, follow-up
Systolic and diastolic blood pressure will be measured in duplicate using an automatic monitor fitted with a child-sized cuff. These blood pressure measures will also be converted to sex-, height-, and age-based blood pressure percentiles using an online calculator developed by Baylor College of Medicine. This will be measured on three consecutive days during each of the measurement weeks below.
Measured: follow-up (week 14)
Physical activity levels, baseline
Physical activity levels will be measured using Actigraph GT3X accelerometers secured with a colorful belt to each child's hip. This data will consist of time spent in the various levels of physical activity (sedentary, light, moderate, and vigorous) and will be measured in 3-day-periods at the time points below. Additionally, parents will be asked to keep a log of when their child is wearing the Actigraph device while at home including the time they take the device off before bed, time they put it on in the morning, and when it is removed for bathing.
Measured: Baseline (week 0)
Physical activity levels, post-intervention
Physical activity levels will be measured using Actigraph GT3X accelerometers secured with a colorful belt to each child's hip. This data will consist of time spent in the various levels of physical activity (sedentary, light, moderate, and vigorous) and will be measured in 3-day-periods at the time points below. Additionally, parents will be asked to keep a log of when their child is wearing the Actigraph device while at home including the time they take the device off before bed, time they put it on in the morning, and when it is removed for bathing.
Measured: Post-intervention (week 7)
Fruit and vegetable liking, baseline to post-intervention
Food liking will be measured during the observed lunch meals using age-appropriate Likert scales that ask children about whether they "like", "neither", or "dislike" the specified food's appearance, smell, taste, and texture, and their overall liking of the food.
Measured: Change in fruit and vegetable liking from baseline (week 0) to post-intervention (week 7)
Fruit and vegetable liking, baseline to follow-up
Food liking will be measured during the observed lunch meals using age-appropriate Likert scales that ask children about whether they "like", "neither", or "dislike" the specified food's appearance, smell, taste, and texture, and their overall liking of the food.
Measured: Change in fruit and vegetable liking from baseline (week 0) to follow-up (week 14)
Willingness to try fruit and vegetable
Willingness to try foods will be measured during the taste-test activity using the Taste Test Tool that involves asking the children a series of questions including: "Have you ever seen this food before?", "Have you ever tried this food before?", "Did you try this food today?", "Would you try this food again at school?", "Would you try this food again at home?"and "Would you ask for this food at home?" Children will be asked to answer "yes", "no", or "not sure". This will only be measured in the children whose classroom has been allocated to the intervention group (nutrition education curriculum)
Measured: Once weekly during the taste-test activity of the nutrition education curriculum (6 weeks total; weeks 1-6)
Satiety, baseline
Satiety will be measured immediately before and after the ad libitum lunch meals where food intake is measured. First, an age-appropriate story will be read to the children to familiarize them with the meanings of "hungry" and "full" and children will be asked to answer questions about the characters' feelings of hunger/fullness based on what they reported eating to ascertain comprehension. Then, satiety will be measured using an age-appropriate 4-point scale developed for preschool children. The children are first asked whether they are hungry or full, and then subsequently asked the intensity of the feeling using "very" or "a little", ie "a little hungry/full" or "very hungry/full".
Measured: Baseline (week 0)
Satiety, post-intervention
Satiety will be measured immediately before and after the ad libitum lunch meals where food intake is measured. First, an age-appropriate story will be read to the children to familiarize them with the meanings of "hungry" and "full" and children will be asked to answer questions about the characters' feelings of hunger/fullness based on what they reported eating to ascertain comprehension. Then, satiety will be measured using an age-appropriate 4-point scale developed for preschool children. The children are first asked whether they are hungry or full, and then subsequently asked the intensity of the feeling using "very" or "a little", ie "a little hungry/full" or "very hungry/full".
Measured: post-intervention (week 7)
Satiety, follow-up
Satiety will be measured immediately before and after the ad libitum lunch meals where food intake is measured. First, an age-appropriate story will be read to the children to familiarize them with the meanings of "hungry" and "full" and children will be asked to answer questions about the characters' feelings of hunger/fullness based on what they reported eating to ascertain comprehension. Then, satiety will be measured using an age-appropriate 4-point scale developed for preschool children. The children are first asked whether they are hungry or full, and then subsequently asked the intensity of the feeling using "very" or "a little", ie "a little hungry/full" or "very hungry/full".
Measured: follow-up (week 14)
Anthropometrics
Each child's height and weight will be measured. This will be used to calculate their BMI-for-age percentile score based on the CDC growth charts.
Measured: Baseline (week 0)
Food intake during snack, baseline
Snack intake (during morning and afternoon snack) will be measured during the same days as the lunch intake measurements, but will use different methods. For snack intake measurements, trained researchers will use visual observation to estimate the children's snack intake that will be recorded using common household measurements (cups, tablespoons, etc). Researchers will each be assigned 4 children to record. They will be asked not to engage with the children. This will be used in their estimate of total energy requirements.
Measured: Baseline (week 0)
Food intake during snack, post-intervention
Snack intake (during morning and afternoon snack) will be measured during the same days as the lunch intake measurements, but will use different methods. For snack intake measurements, trained researchers will use visual observation to estimate the children's snack intake that will be recorded using common household measurements (cups, tablespoons, etc). Researchers will each be assigned 4 children to record. They will be asked not to engage with the children. This will be used in their estimate of total energy requirements.
Measured: Post-intervention (week 7)
Food intake at home, baseline
Parents will be asked to report their child's usual diet using two researcher-conducted, parent-assisted 24-hour dietary recall method. This will occur on the same days that lunch intake and skin carotenoids will be recorded. This will be collected using Nutrition Data System for Research (NDSR) program that has an integrated script for prompting of dietary intake. There are additional supplementary questions following the dietary recall that ask parents to report the amount of time the child spent in sedentary activity and amount of screen time the child engaged in the previous day, both in minutes.
Measured: Baseline (week 0)
Food intake at home, post-intervention
Parents will be asked to report their child's usual diet using two researcher-conducted, parent-assisted 24-hour dietary recall method. This will occur on the same days that lunch intake and skin carotenoids will be recorded. This will be collected using Nutrition Data System for Research (NDSR) program that has an integrated script for prompting of dietary intake. There are additional supplementary questions following the dietary recall that ask parents to report the amount of time the child spent in sedentary activity and amount of screen time the child engaged in the previous day, both in minutes.
Measured: Post-intervention (week 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start14 Feb 2023
- Primary completion30 Jul 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Children, OnlyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group-randomized trial with individual-level outcomes
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibylle Kranz, PhD, RDN, University of Virginia
- Investigators
- Sibylle Kranz, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730530
- Sponsor's protocol ID
- SBS 5304
- Status last verified
- Apr 2024
- First submitted
- 1 Feb 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD will be available after publication of results. The name of the childcare centers that participated will not be mentioned in any released data to protect the identity of participating children.
Publications
Lioret S, Campbell KJ, McNaughton SA, Cameron AJ, Salmon J, Abbott G, Hesketh KD. Lifestyle Patterns Begin in Early Childhood, Persist and Are Socioeconomically Patterned, Confirming the Importance of Early Life Interventions. Nutrients. 2020 Mar 9;12(3):724. doi: 10.3390/nu12030724.
PubMed 32182889Livingstone MB, Robson PJ. Measurement of dietary intake in children. Proc Nutr Soc. 2000 May;59(2):279-93. doi: 10.1017/s0029665100000318.
PubMed 10946797Treiber FA, Leonard SB, Frank G, Musante L, Davis H, Strong WB, Levy M. Dietary assessment instruments for preschool children: reliability of parental responses to the 24-hour recall and a food frequency questionnaire. J Am Diet Assoc. 1990 Jun;90(6):814-20.
PubMed 2345254Scarmo S, Henebery K, Peracchio H, Cartmel B, Lin H, Ermakov IV, Gellermann W, Bernstein PS, Duffy VB, Mayne ST. Skin carotenoid status measured by resonance Raman spectroscopy as a biomarker of fruit and vegetable intake in preschool children. Eur J Clin Nutr. 2012 May;66(5):555-60. doi: 10.1038/ejcn.2012.31. Epub 2012 Mar 21.
PubMed 22434053Hodder RK, O'Brien KM, Stacey FG, Wyse RJ, Clinton-McHarg T, Tzelepis F, James EL, Bartlem KM, Nathan NK, Sutherland R, Robson E, Yoong SL, Wolfenden L. Interventions for increasing fruit and vegetable consumption in children aged five years and under. Cochrane Database Syst Rev. 2018 May 17;5(5):CD008552. doi: 10.1002/14651858.CD008552.pub5.
PubMed 29770960Gripshover SJ, Markman EM. Teaching young children a theory of nutrition: conceptual change and the potential for increased vegetable consumption. Psychol Sci. 2013 Aug;24(8):1541-53. doi: 10.1177/0956797612474827. Epub 2013 Jun 26.
PubMed 23804961Witt KE, Dunn C. Increasing fruit and vegetable consumption among preschoolers: evaluation of color me healthy. J Nutr Educ Behav. 2012 Mar-Apr;44(2):107-13. doi: 10.1016/j.jneb.2011.01.002. Epub 2011 Sep 16.
PubMed 21924957Cooke L. The importance of exposure for healthy eating in childhood: a review. J Hum Nutr Diet. 2007 Aug;20(4):294-301. doi: 10.1111/j.1365-277X.2007.00804.x.
PubMed 17635306Singer MR, Moore LL, Garrahie EJ, Ellison RC. The tracking of nutrient intake in young children: the Framingham Children's Study. Am J Public Health. 1995 Dec;85(12):1673-7. doi: 10.2105/ajph.85.12.1673.
PubMed 7503343Wuhl E. Hypertension in childhood obesity. Acta Paediatr. 2019 Jan;108(1):37-43. doi: 10.1111/apa.14551. Epub 2018 Sep 19.
PubMed 30144170Miguel-Berges ML, Zachari K, Santaliestra-Pasias AM, Mouratidou T, Androutsos O, Iotova V, Galcheva S, De Craemer M, Cardon G, Koletzko B, Kulaga Z, Manios Y, Moreno LA. Clustering of energy balance-related behaviours and parental education in European preschool children: the ToyBox study. Br J Nutr. 2017 Dec;118(12):1089-1096. doi: 10.1017/S0007114517003129. Epub 2017 Dec 4.
PubMed 29198192Kranz S, Brauchla M, Campbell WW, Mattes RD, Schwichtenberg AJ. High-Protein and High-Dietary Fiber Breakfasts Result in Equal Feelings of Fullness and Better Diet Quality in Low-Income Preschoolers Compared with Their Usual Breakfast. J Nutr. 2017 Mar;147(3):445-452. doi: 10.3945/jn.116.234153. Epub 2017 Jan 11.
PubMed 28077732
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Education Intervention to Improve Fruit and Vegetable Consumption in Preschoolers
- ClinicalTrials.gov ID
- NCT05730530
- Acronym / sponsor ID
- SBS 5304
- Conditions
- Children, Only, Nutrition, Healthy
- Keywords
- Preschool, Fruits and vegetables, Nutrition education, Behavior change theory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 16 Feb 2023 (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 goal of this randomized controlled trial is to examine fruit and vegetable consumption in preschoolers following a nutrition education curriculum. The main questions it aims to answer is:
- Is this intervention consisting of nutrition education and taste-test activities able to improve fruit and vegetable consumption in preschoolers during their usual lunch meal?
- Is the improvement of fruit and vegetable consumption sustained for at least 6 weeks after completion of the intervention?
Participants in the intervention classroom will partake in 3 nutrition education sessions per week during the 6-week-long curriculum. Researchers will compare this to changes in fruit and vegetable intake of the children in the control classroom, who will undergo identical measurements, but will not participate in the curriculum.
Detailed description
Fruit and vegetable consumption in preschoolers in the United States is very low, with the majority of children not meeting the national recommendations. However, there is a lack of data indicating effective strategies to increase preschooler's fruit and vegetable intake and whether socio-demographic and eating behavior-related child characteristics (child eating behavior and relationship with food) may predict fruit and vegetable consumption in preschoolers as well as their response to the intervention. This information is important for researchers because it may allow for more effective development of future interventions that consider these potential external influences. There is also a lack of evidence-based interventions that are based on theoretical behavior change frameworks and the associated behavior change techniques. Furthermore, studies lack a long enough follow-up to measure whether any possibly observed behavior change (more fruits and vegetables consumed) in the preschoolers is maintained following the cessation of the intervention.
While fruit and vegetable consumption is associated with lower blood pressure in adults, little is known about this relationship in children. This will be examined in our study to determine if there is an association between blood pressure and fruit and vegetable intake at baseline and whether this association changes following the intervention.
To control for differences in energy needs, it is important to control for children's BMI-for-age percentile, which is calculated using their age, height, and weight. This is necessary because children who have higher BMI percentiles typically require more total energy consumption, which may influence fruit and vegetable consumption. Additionally, previous studies have observed that children with greater BMI percentile are less likely to eat adequate amounts of fruits and vegetables. However, this has not been measured in an interventional manner, and therefore it is unknown whether these associations are omnipotent, and whether they remain following a fruit and vegetable intervention. Therefore, our study will examine these relationships in a small sample of preschoolers to either support or contradict these previous observations.
In addition to measuring fruit and vegetable intake, it is also important to measure physical activity levels as a control variable for total energy requirements, as changes in physical activity levels may confound changes in dietary intake, including intake of fruits and vegetables. This is especially true of interventions that span different seasons (ie. winter and spring), as these may also influence physical activity levels and, subsequently, energy requirements. Secondarily, previous research has established an association between fruit and vegetable intake and both physical activity levels and screen time in children and adults. However, no studies have explored this relationship in preschool-aged children. Additionally, the evidence of the relationship between these two variables is limited to cross-sectional data; it is unknown whether an increase in one would influence the other. We plan to examine this in a small sample of preschoolers in an interventional setting.
Therefore, the purpose of this research is to determine whether such an intervention is able to increase and maintain fruit and vegetable intake during lunch in a sample of preschoolers, controlling for age, BMI percentile, and activity level. Additional aims are 1) to explore the relationship between fruit and vegetable intake and blood pressure, 2) examine the relationship between FV intake and physical activity levels in this sample of preschoolers, and 3) examine how BMI-percentile and socio-demographic and child- and parent-related eating-related characteristics are associated with fruit and vegetable intake. We plan to publish our findings in a scientific journal to contribute to the advancement of knowledge regarding interventions to improve fruit and vegetable intake in preschoolers, as information is evidently needed in this topic.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group-randomized trial with individual-level outcomes
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Nutrition education curriculumClassroom assigned to receive the 6-week long nutrition education curriculum |
| Control | No intervention | –Classroom assigned to receive no intervention |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Typically-developing children with no food allergies and not taking medication
Key exclusion criteria (3 listed)
- Food Allergies
- Taking medications
- Developmental delays
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 education curriculumThis intervention consists of a 6-week-long nutrition education curriculum aimed at improving fruit and vegetable acceptance and consumption. Sessions will occur within the classroom 3 times per week for 6 weeks. Each week, the sessions will consist of 2 days of teaching activities and 1 day of taste-test activities designed for children to guess various common fruits and vegetables, assemble recipes including 2-4 different fruits and vegetables, and then taste the foods. These activities will be conducted in a full-classroom group setting. | Behavioural | Intervention |
Primary outcome
Fruit and vegetable intake post-intervention
Time frame: Change in fruit and vegetable intake from baseline (week 0) to post-intervention (week 7)
Fruits and vegetables consumed during a typical lunch meal, measured using plate-waste weighing method, which involves subtracting the grams of food leftover from the grams of food served to estimate the grams of food consumed. All weighing of the foods will be done in the Diet and Nutrition Lab before and after going to the childcare center. This will be measured on three consecutive days during each of the measurement weeks below.
Fruit and vegetable intake at follow-up
Time frame: Change in fruit and vegetable intake from baseline (week 0) to follow-up (week 14)
Fruits and vegetables consumed during a typical lunch meal, measured using plate-waste weighing method, which involves subtracting the grams of food leftover from the grams of food served to estimate the grams of food consumed. All weighing of the foods will be done in the Diet and Nutrition Lab before and after going to the childcare center. This will be measured on three consecutive days during each of the measurement weeks below.
Skin carotenoid levels post-intervention
Time frame: Change in fruit and vegetable intake from baseline (week 0) to post-intervention (week 7)
Children's fruit and vegetable intake will be confirmed using a measure of skin carotenoid levels. This will be measured using a VeggieMeter device, which utilizes non-invasive reflection spectroscopy to estimate the amount of dietary carotenoids deposited into the skin. Children will be asked to wash their hands and then place their right pointer finger on a small lens for approximately 15 seconds. This will be measured immediately following the 3 measured lunch meals at the 3 time points.
Skin carotenoid levels at follow-up
Time frame: Change in fruit and vegetable intake from baseline (week 0) to follow-up (week 14)
Children's fruit and vegetable intake will be confirmed using a measure of skin carotenoid levels. This will be measured using a VeggieMeter device, which utilizes non-invasive reflection spectroscopy to estimate the amount of dietary carotenoids deposited into the skin. Children will be asked to wash their hands and then place their right pointer finger on a small lens for approximately 15 seconds. This will be measured immediately following the 3 measured lunch meals at the 3 time points.
16 secondary outcomes
Systolic and diastolic blood pressure, baseline
Time frame: Baseline (week 0)
Systolic and diastolic blood pressure, post-intervention
Time frame: post-intervention (week 7)
Systolic and diastolic blood pressure, follow-up
Time frame: follow-up (week 14)
Physical activity levels, baseline
Time frame: Baseline (week 0)
Physical activity levels, post-intervention
Time frame: Post-intervention (week 7)
Fruit and vegetable liking, baseline to post-intervention
Time frame: Change in fruit and vegetable liking from baseline (week 0) to post-intervention (week 7)
Fruit and vegetable liking, baseline to follow-up
Time frame: Change in fruit and vegetable liking from baseline (week 0) to follow-up (week 14)
Willingness to try fruit and vegetable
Time frame: Once weekly during the taste-test activity of the nutrition education curriculum (6 weeks total; weeks 1-6)
Satiety, baseline
Time frame: Baseline (week 0)
Satiety, post-intervention
Time frame: post-intervention (week 7)
Satiety, follow-up
Time frame: follow-up (week 14)
Anthropometrics
Time frame: Baseline (week 0)
Food intake during snack, baseline
Time frame: Baseline (week 0)
Food intake during snack, post-intervention
Time frame: Post-intervention (week 7)
Food intake at home, baseline
Time frame: Baseline (week 0)
Food intake at home, post-intervention
Time frame: Post-intervention (week 7)
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 3 Apr 2024.
- Background: PubMed 32182889Lioret S, Campbell KJ, McNaughton SA, Cameron AJ, Salmon J, Abbott G, Hesketh KD. Lifestyle Patterns Begin in Early Childhood, Persist and Are Socioeconomically Patterned, Confirming the Importance of Early Life Interventions. Nutrients. 2020 Mar 9;12(3):724. doi: 10.3390/nu12030724.
- Background: PubMed 10946797Livingstone MB, Robson PJ. Measurement of dietary intake in children. Proc Nutr Soc. 2000 May;59(2):279-93. doi: 10.1017/s0029665100000318.
- Background: PubMed 2345254Treiber FA, Leonard SB, Frank G, Musante L, Davis H, Strong WB, Levy M. Dietary assessment instruments for preschool children: reliability of parental responses to the 24-hour recall and a food frequency questionnaire. J Am Diet Assoc. 1990 Jun;90(6):814-20.
- Background: PubMed 22434053Scarmo S, Henebery K, Peracchio H, Cartmel B, Lin H, Ermakov IV, Gellermann W, Bernstein PS, Duffy VB, Mayne ST. Skin carotenoid status measured by resonance Raman spectroscopy as a biomarker of fruit and vegetable intake in preschool children. Eur J Clin Nutr. 2012 May;66(5):555-60. doi: 10.1038/ejcn.2012.31. Epub 2012 Mar 21.
- Background: PubMed 29770960Hodder RK, O'Brien KM, Stacey FG, Wyse RJ, Clinton-McHarg T, Tzelepis F, James EL, Bartlem KM, Nathan NK, Sutherland R, Robson E, Yoong SL, Wolfenden L. Interventions for increasing fruit and vegetable consumption in children aged five years and under. Cochrane Database Syst Rev. 2018 May 17;5(5):CD008552. doi: 10.1002/14651858.CD008552.pub5.
- Background: PubMed 23804961Gripshover SJ, Markman EM. Teaching young children a theory of nutrition: conceptual change and the potential for increased vegetable consumption. Psychol Sci. 2013 Aug;24(8):1541-53. doi: 10.1177/0956797612474827. Epub 2013 Jun 26.
- Background: PubMed 21924957Witt KE, Dunn C. Increasing fruit and vegetable consumption among preschoolers: evaluation of color me healthy. J Nutr Educ Behav. 2012 Mar-Apr;44(2):107-13. doi: 10.1016/j.jneb.2011.01.002. Epub 2011 Sep 16.
- Background: PubMed 17635306Cooke L. The importance of exposure for healthy eating in childhood: a review. J Hum Nutr Diet. 2007 Aug;20(4):294-301. doi: 10.1111/j.1365-277X.2007.00804.x.
- Background: PubMed 7503343Singer MR, Moore LL, Garrahie EJ, Ellison RC. The tracking of nutrient intake in young children: the Framingham Children's Study. Am J Public Health. 1995 Dec;85(12):1673-7. doi: 10.2105/ajph.85.12.1673.
- Background: PubMed 30144170Wuhl E. Hypertension in childhood obesity. Acta Paediatr. 2019 Jan;108(1):37-43. doi: 10.1111/apa.14551. Epub 2018 Sep 19.
- Background: PubMed 29198192Miguel-Berges ML, Zachari K, Santaliestra-Pasias AM, Mouratidou T, Androutsos O, Iotova V, Galcheva S, De Craemer M, Cardon G, Koletzko B, Kulaga Z, Manios Y, Moreno LA. Clustering of energy balance-related behaviours and parental education in European preschool children: the ToyBox study. Br J Nutr. 2017 Dec;118(12):1089-1096. doi: 10.1017/S0007114517003129. Epub 2017 Dec 4.
- Background: PubMed 28077732Kranz S, Brauchla M, Campbell WW, Mattes RD, Schwichtenberg AJ. High-Protein and High-Dietary Fiber Breakfasts Result in Equal Feelings of Fullness and Better Diet Quality in Low-Income Preschoolers Compared with Their Usual Breakfast. J Nutr. 2017 Mar;147(3):445-452. doi: 10.3945/jn.116.234153. Epub 2017 Jan 11.
- Individual participant dataSharing planned: Yes. All IPD will be available after publication of results. The name of the childcare centers that participated will not be mentioned in any released data to protect the identity of participating children.
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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.
Sibylle Kranz, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition education curriculum in people with Children, Only and Nutrition, Healthy, run by University of Virginia 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 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 3 Apr 2024. 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?
Fruit and vegetable intake post-intervention (time frame: Change in fruit and vegetable intake from baseline (week 0) to post-intervention (week 7)). The study lists 4 primary outcomes in all. 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 NCT05730530, which also lists 12 linked publications.
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 3 Apr 2024.