NCT07506772

Brief Summary

A balanced diet is critical for preschool aged children; meals must be sufficiently diverse to provide the essential nutrients required for rapid physical and cognitive development. Because dietary habits established in early childhood often persist into adulthood, prioritizing this age group is a cost-effective investment in long-term national health and productivity. However, the National Food Consumption Survey in Ethiopia indicates a significant gap in dietary quality, with only 20% of households across all age groups consuming five or more food groups. Implementing multi-component nutrition interventions is essential, as these strategies significantly influence both the eating habits and dietary preferences of preschool children.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
840

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress92%
Jan 2026Jun 2026

Study Start

First participant enrolled

January 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2026

Expected
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 4, 2026

Last Update Submit

March 28, 2026

Conditions

Keywords

Deit QualityPreschool childrenKindergartenCluster Randomised control trialNutrition education

Outcome Measures

Primary Outcomes (1)

  • Mean School-Lunch Dietary Diversity Score (mDDS)

    The nutritional quality of home-packed school meals (including snacks and lunches) will be assessed using a structured parent reported lunchbox inventory over two non-consecutive school days. The score is calculated based on the presence of 9 distinct food groups adapted from the FAO(Food and Agriculture Organization)/WHO(World Health Organization) dietary diversity indicators: Starchy staples (grains, roots, tubers) Legumes and nuts Dairy products Flesh foods (meat, poultry, fish) Eggs Vitamin A-rich fruits and vegetables Dark green leafy vegetables Other vegetables Other fruits. For each observation day, a score is calculated (Range: 0-9). The final primary outcome is the mean score across the two data collection days. A higher score represents a more diverse and higher-quality school meal.

    Baseline and 6 months post-intervention

Secondary Outcomes (1)

  • Child's Healthy Dietary Preference Score

    Baseline and 6 months post-intervention.

Study Arms (2)

Parental Nutrition education

EXPERIMENTAL
Behavioral: Nutrition education

Standard care

NO INTERVENTION

Interventions

Parent-Focused Component: The intervention group will receive weekly nutrition education delivered through a multi-modal approach involving mHealth (Telegram) and printed materials. Educational content is derived from the Ethiopian Food-Based Dietary Guidelines and evidence-based literature, culturally tailored to the local context. Printed leaflets will be provided in both Amharic and Afan Oromo and will incorporate pictorial aids to ensure accessibility for parents and caregivers with limited literacy levels. Child-Focused Component: Simultaneously, students will participate in bi-weekly nutrition education sessions led by trained nutritionists or health professionals. These sessions are designed based on WHO age-appropriate nutrition education recommendations and will be conducted throughout the duration of the intervention period.

Parental Nutrition education

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 4-7 years attending kindergarten schools in the selected clusters.
  • Parents or caregivers willing to provide written informed consent.

You may not qualify if:

  • Students who will not finish the school year/intervention semister in the selected cluster/school.
  • Mothers/caregivers who will not give consent for the participation in the study will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jimma University

Jimma, Oromiya, Ethiopia

RECRUITING

Related Publications (2)

  • De Bock F, Breitenstein L, Fischer JE. Positive impact of a pre-school-based nutritional intervention on children's fruit and vegetable intake: results of a cluster-randomized trial. Public Health Nutr. 2012 Mar;15(3):466-75.

    BACKGROUND
  • Hu C, Ye D, Li Y, Huang Y, Li L, Gao Y, et al. Evaluation of a kindergarten-based nutrition education intervention for pre-school children in China. Public Health Nutr. 2010 Feb;13(2):253-60.

    BACKGROUND

MeSH Terms

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Yordanos Bekele Tadesse, MSc

    Jimma University, Mizan Tepi University

    PRINCIPAL INVESTIGATOR
  • Desalegn Tamiru, PhD

    Jimma University

    PRINCIPAL INVESTIGATOR
  • Melese Sinaga, PhD

    Jimma University, 2Rehabilitation Research Centre (REVAL), Rehabilitation Sciences and Physiotherapy, Hasselt University, Wetenschapspark 7, 3590 Diepenbeek, Belgium.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yordanos Bekele, MSc

CONTACT

Desalegn Tamiru, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator and PhD Candidate, Department of Nutrition and Dietetics

Study Record Dates

First Submitted

March 4, 2026

First Posted

April 2, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

June 24, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

April 2, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations