NCT07700173

Brief Summary

This explanatory sequential mixed-methods study evaluated a six-week Piaget-based nutrition education programme for preschool children. Seven public preschools were randomized at the school level to an intervention condition (three preschools) or a usual-curriculum control condition (four preschools). The intervention consisted of six weekly, approximately 30-minute, developmentally tailored sessions delivered to groups of children in their usual classrooms. Mothers completed measures of children's food consumption frequency, nutrition behavior, and eating behavior before and immediately after the programme. Following the quantitative phase, three focus groups with 18 mothers from intervention preschools explored perceived changes and helped interpret the quantitative patterns. Because preschool identifiers were not retained in the final analytical dataset, the reported child-level analyses did not adjust for clustering and are interpreted as exploratory.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
268

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
Last Updated

August 25, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 7, 2026

Last Update Submit

August 23, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change from baseline in food consumption frequency

    In the Food Consumption Frequency Questionnaire, there are foods that include 7 food groups (dairy group, meat group, vegetable group, fruit group, grain group, oil/margarine group, and sweet group) aimed at determining the child's food consumption status (Güneş et al., 2016). Food consumption frequency is recorded in nine different categories (\>6/day, 4-5/day, 2-3/day, 1/day, 5-6/week, 2-4/week, 1/week, 1-3/month, 1-none/month). The Food Consumption Frequency Questionnaire specific to Turkish children was developed by Güneş and colleagues in 2016. The form includes not only food items but also commonly used ingredients in Turkish cuisine. During the development phase of the form, a food atlas containing the most frequently consumed foods, beverages, and some Turkish dishes was used. Results are reported by food item or food group; the questionnaire does not yield a single total score.

    Baseline and immediately after completion of the six-week intervention

  • Change in Nutrition Behavior Scale (NBS) Score

    In determining eating behaviors, the Nutrition Behavior Scale developed by Edmundson et al. (1996) and adapted for Turkish children by Öztürk (2010) was used. The scale consists of fourteen different items, each containing two different food items-low-fat, high-fat, salty, and unsalted-depicted in pictures and presented as choices, to determine children's food consumption. Students are asked to indicate which of the two comparable food items in each question item they eat more. The scale items receive a value of -1 for unhealthy food and +1 for healthy food. The total score ranges from -14 to +14. A high total score on the scale indicates a healthy eating habit. The reliability of the scale has been reported as r=0.76 (Öztürk, 2010).

    Baseline and immediately after completion of the six-week intervention

  • Change in Children's Eating Behavior Questionnaire (CEBQ) Subscale Scores

    Developed by Wardle et al. (2001), the Children's Eating Behaviour Questionnaire (CEBQ) is a 35-item parent-reported instrument that assesses children's eating behaviours on a five-point Likert scale ranging from 1 (never) to 5 (always). It comprises eight subscales: Food Responsiveness, Emotional Overeating, Enjoyment of Food, Desire to Drink, Satiety Responsiveness, Slowness in Eating, Emotional Undereating, and Food Fussiness. Each subscale is scored separately, with higher scores indicating a greater level of the behaviour represented by that subscale. The original instrument demonstrated an eight-factor structure, with Cronbach's alpha coefficients ranging from 0.74 to 0.91. The Turkish validity and reliability study was conducted by Yılmaz et al. (2011).

    Baseline and immediately after completion of the six-week intervention

Study Arms (2)

Piaget-Based Nutrition Education

EXPERIMENTAL

Children attending the three intervention preschools received the six-week Piaget-based nutrition education programme in their usual classrooms. A total of 138 mother-child dyads were allocated to intervention preschools; 130 children received at least part of the programme, and 127 dyads were included in the reported per-protocol analysis.

Behavioral: Piaget-Based Nutrition Education Program

Usual Preschool Curriculum

NO INTERVENTION

Children attending the four control preschools continued their usual preschool curriculum and did not receive the Piaget-based nutrition education programme during the study period. A total of 130 mother-child dyads were allocated to control preschools, and 111 dyads were included in the reported analysis.

Interventions

The researcher delivered six weekly sessions, each lasting approximately 30 minutes, to groups of 8-15 preschool children in their usual classrooms. The programme was tailored to the preoperational stage of cognitive development and used simple language, concrete classification, play, pictures, coloring, cartoons, songs, sensory exploration, and fruit-yogurt preparation. Sessions addressed food groups; fruits; vegetables; energy- and growth-supporting foods; milk and dental health; and foods to be consumed every day or occasionally.

Piaget-Based Nutrition Education

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Mothers of children aged 3-6 attending kindergartens affiliated with the Provincial Directorate of National Education
  • Mothers whose children do not have any health problems affecting their nutritional status
  • Mothers aged 18 and above
  • Mothers who are at least literate.

You may not qualify if:

  • Children with hearing and speech problems,
  • Children who do not understand or speak Turkish,
  • Children with any illness or learning difficulties,
  • Those who participate for a maximum of 2 weeks during the six-week nutrition training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Preschools affiliated with the Provincial Directorate of National Education, Uşak

Uşak, 64200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Because of the nature of the educational intervention, children, mothers, and the researcher delivering the intervention were aware of group assignment. Blinding of outcome assessors and data analysts was not documented.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Seven public preschools were randomized at the preschool (cluster) level to either the intervention condition (three preschools) or the control condition (four preschools) using a random-number table. All participating children within each preschool received the condition assigned to that preschool. Preschools were the units of randomization, and children were the units of observation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Doctor

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 13, 2026

Study Start

September 30, 2022

Primary Completion

February 20, 2023

Study Completion

June 30, 2023

Last Updated

August 25, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations