NCT05730530

Brief 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. 1.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?
  2. 2.Is the improvement of fruit and vegetable consumption sustained for at least 6 weeks after completion of the intervention?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

February 14, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 16, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

April 3, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

February 1, 2023

Last Update Submit

April 2, 2024

Conditions

Keywords

PreschoolFruits and vegetablesNutrition educationBehavior change theory

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Change in fruit and vegetable intake from baseline (week 0) to follow-up (week 14)

Secondary Outcomes (16)

  • Systolic and diastolic blood pressure, baseline

    Baseline (week 0)

  • Systolic and diastolic blood pressure, post-intervention

    post-intervention (week 7)

  • Systolic and diastolic blood pressure, follow-up

    follow-up (week 14)

  • Physical activity levels, baseline

    Baseline (week 0)

  • Physical activity levels, post-intervention

    Post-intervention (week 7)

  • +11 more secondary outcomes

Other Outcomes (2)

  • Sociodemographic information

    Baseline (week 0)

  • Child eating behavior

    Baseline (week 0)

Study Arms (2)

Intervention

EXPERIMENTAL

Classroom assigned to receive the 6-week long nutrition education curriculum

Behavioral: Nutrition education curriculum

Control

NO INTERVENTION

Classroom assigned to receive no intervention

Interventions

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.

Intervention

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Typically-developing children with no food allergies and not taking medication

You may not qualify if:

  • Food Allergies
  • Taking medications
  • Developmental delays

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westminster Child Care Center

Charlottesville, Virginia, 22903, United States

Location

Related Publications (12)

  • 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.

    PMID: 32182889BACKGROUND
  • Livingstone MB, Robson PJ. Measurement of dietary intake in children. Proc Nutr Soc. 2000 May;59(2):279-93. doi: 10.1017/s0029665100000318.

    PMID: 10946797BACKGROUND
  • 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.

    PMID: 2345254BACKGROUND
  • 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.

    PMID: 22434053BACKGROUND
  • 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.

    PMID: 29770960BACKGROUND
  • 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.

    PMID: 23804961BACKGROUND
  • 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.

    PMID: 21924957BACKGROUND
  • 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.

    PMID: 17635306BACKGROUND
  • 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.

    PMID: 7503343BACKGROUND
  • Wuhl E. Hypertension in childhood obesity. Acta Paediatr. 2019 Jan;108(1):37-43. doi: 10.1111/apa.14551. Epub 2018 Sep 19.

    PMID: 30144170BACKGROUND
  • 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.

    PMID: 29198192BACKGROUND
  • Kranz 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.

    PMID: 28077732BACKGROUND

Study Officials

  • Sibylle Kranz, PhD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Group-randomized trial with individual-level outcomes
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 1, 2023

First Posted

February 16, 2023

Study Start

February 14, 2023

Primary Completion

July 30, 2023

Study Completion

August 1, 2023

Last Updated

April 3, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
This data is collected as part of a doctoral dissertation. Data will become available following dissertation defense and publication of results.
Access Criteria
Depends on the journal criteria

Locations