Study Summary
This trial tests if nutrition education and taste-test activities can improve preschoolers' fruit & veggie intake over 6 weeks.
- Childhood
- Healthy Nutrition
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 16 Secondary · Reporting Duration: Once weekly during the taste-test activity of the nutrition education curriculum (6 weeks total; weeks 1-6)
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Control
1 of 2
Intervention
1 of 2
Active Control
Experimental Treatment
16 Total Participants · 2 Treatment Groups
Primary Treatment: Intervention · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 3 - 5 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- 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.
- Livingstone MB, Robson PJ. Measurement of dietary intake in children. Proc Nutr Soc. 2000 May;59(2):279-93. doi: 10.1017/s0029665100000318.
- Treiber 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.
- Scarmo 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.
- Hodder 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.
- Gripshover 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.
- Witt 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.
- Cooke 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.
- Singer 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.
- Wuhl E. Hypertension in childhood obesity. Acta Paediatr. 2019 Jan;108(1):37-43. doi: 10.1111/apa.14551. Epub 2018 Sep 19.
- Miguel-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.
- Kranz, Sibylle, Mary Brauchla, Wayne W Campbell, Rickard D Mattes, and Amy J Schwichtenberg. 2017. “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”. The Journal of Nutrition. Oxford University Press (OUP). doi:10.3945/jn.116.234153.
- Sibylle Kranz, PhD, RDN 2023. "Fruit and Vegetable Intake in Preschoolers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05730530.
Frequently Asked Questions
Does this investigation include participants aged 35 or older?
"This participant cohort includes individuals aged 3 to 5 years old." - Anonymous Online Contributor
Is there any way I could join this medical study?
"To be considered eligible, applicants must have been born in the last 5 years and currently between 3 to 5. This medical study is seeking 16 total participants." - Anonymous Online Contributor
Are there any openings presently available for this trial?
"Affirmative. Clinicaltrials.gov shows that this research project, which was first broadcasted on February 13th 2023, is actively looking for new members. 16 individuals are being sought from a single medical facility." - Anonymous Online Contributor
How many people have volunteered to participate in this research endeavor?
"Affirmative. The clinical trial is actively recruiting, as indicated on the clinicaltrials.gov site which was initiated on February 13th 2023 and modified lastly on February 12th 2023. 16 individuals are expected to be recruited across a single medical centre for this research endeavour." - Anonymous Online Contributor
What is the hoped-for outcome of this medical experiment?
"The main goal of this research, which will be assessed over a seven week period, is to assess the change in fruit and vegetable intake from baseline. Secondary objectives include measuring systolic and diastolic blood pressure at both post-intervention, using an automatic monitor fitted with a child-sized cuff along with sex-, height-, and age-based blood pressure percentiles, as well as physical activity levels via Actigraph GT3X accelerometers secured on each participant's hip. Parents are also requested to document when their children wear or take off the device before bedtime or while bathing." - Anonymous Online Contributor