- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07506772
Quality of Home Packed School Lunch Among Children Attending Kindergarten School in Jimma Zone, South West Ethiopia, 2026
Effect of Nutrition Education on the Diet Quality of Home Packed School Lunch Among Preschool Children Attending Kindergarten School in Jimma Zone, South West Ethiopia, 2026
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background and Rationale Dietary habits acquired during early childhood frequently persist through adolescence and into young adulthood. Children develop preferences for foods through repeated exposure and are influenced by parental modeling, rewards, and shared mealtime enjoyments. Beyond individual factors, child nutrition is shaped by a complex interplay of parental preferences, parenting styles, food security, and environmental influences such as media and childcare policies. In the school environment, key drivers include nutrition policies, formal curricula, and the knowledge and practices of staff.
Study Aim and Design This study aims to evaluate the impact of a multi-component nutrition education intervention on the diet quality and dietary preferences of kindergarten students in the Jimma Zone, Southwest Ethiopia. A mixed-methods approach will be employed, utilizing a cluster randomized controlled trial (cRCT) and concurrent cross-sectional design.
Methodology A total of 451 students from ten clusters (schools) will be enrolled. These clusters will be randomly assigned to either the intervention or control group (5 schools each), with approximately 45 students selected per cluster. The intervention includes weekly nutrition education for parents delivered via leaflets and mHealth (vie Telegram) and school based nutrition information for students led by trained female health care providers/nutritionists.
Outcome Measures & analysis The primary outcomes are mean child diet quality (DDS) and dietary preferences, assessed at baseline and endline. Data will be managed via double entry in EpiData and analyzed using STATA version 15.1. Following an intention-to-treat (ITT) principle, a Difference-in-Differences (DiD) estimator will be used to compare the change in mean scores between groups over the 6-month intervention period. To account for the clustered nature of the data and potential residual confounding, Generalized Estimating Equations (GEE) and mixed-effects multilevel linear regression models will be applied.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yordanos Bekele, MSC
- Phone Number: +251917106192
- Email: yordybeke@gmail.com
Study Contact Backup
- Name: Desalegn Tamiru, PhD
- Phone Number: +251912373397
- Email: dessalegn97@gmail.com
Study Locations
-
-
Oromiya
-
Jimma, Oromiya, Ethiopia
- Recruiting
- Jimma University
-
Contact:
- Yordanos Bekele, MSC
- Phone Number: +251917106192
- Email: yordybeke@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion criteria
- Children aged 4-7 years attending kindergarten schools in the selected clusters.
- Parents or caregivers willing to provide written informed consent.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard care
|
|
|
Experimental: Parental Nutrition education
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean School-Lunch Dietary Diversity Score (mDDS)
Time Frame: Baseline and 6 months post-intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child's Healthy Dietary Preference Score
Time Frame: Baseline and 6 months post-intervention.
|
Children's preferences for healthy versus unhealthy foods will be assessed using a pictorial tool adapted for the local Ethiopian context. Children are presented with 10 pairs of standardized images (one nutrient-dense item and one energy-dense/processed item). For each pair, the child selects their preferred item. A score of 1 is given for each healthy choice. The total score ranges from 0 (lowest preference) to 10 (highest preference). The outcome is the change in the mean score from baseline to endline. A higher score indicates a stronger preference for healthy dietary options. |
Baseline and 6 months post-intervention.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: 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.
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RP0038/13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nutritional Status
-
Second Affiliated Hospital, School of Medicine,...Zhejiang University; Sir Run Run Shaw Hospital; Red Cross Hospital, Hangzhou,... and other collaboratorsCompleted
-
GlaxoSmithKlineCompleted
-
University of CopenhagenUniversity of Aberdeen; University of Stirling; Noakhali Science and Technology... and other collaboratorsNot yet recruitingNutritional Status | Climate Change | Micronutrient Status | Omega 3 Fat Status | Fish Consumption | Dietary Pattern | Female AutonomyBangladesh
-
International Centre for Diarrhoeal Disease Research...United States Agency for International Development (USAID)Not yet recruiting
-
China Medical University HospitalUnknown
-
GlaxoSmithKlineCompleted
-
Centre Hospitalier Universitaire DijonCompleted
-
Hillel Yaffe Medical CenterUnknownNutritional StatusIsrael
-
Bandim Health ProjectCompleted
-
North-West University, South AfricaMedical Research Council, South Africa; National Research Foundation of South... and other collaboratorsCompletedMalnutrition | Vitamin A Status | Iron Status | Zinc StatusSouth Africa
Clinical Trials on Nutrition education
-
Loma Linda UniversityCompletedSedentary LifestyleUnited States
-
McGill UniversityInternational Development Research Centre, CanadaCompletedImproving Young Child NutritionGhana
-
Second Affiliated Hospital, School of Medicine,...UnknownNutrition Disorders | Gastric CancerChina
-
University of Ontario Institute of TechnologyCanadian Institutes of Health Research (CIHR)CompletedNutrition, HealthyCanada
-
Penn State UniversityCompletedCardiometabolic Risk FactorsUnited States
-
University of Alabama, TuscaloosaAcademy of Nutrition and DieteticsRecruitingBrain InjuriesUnited States
-
University of MiamiAcademy of Spinal Cord Injury Professionals, Inc.Active, not recruiting
-
Jennifer BowdenActive, not recruitingEnhanced Recovery After Surgery | Nutrition EducationUnited States
-
Chang Gung Memorial HospitalMinistry of Science and Technology, TaiwanActive, not recruitingRelative Energy Deficiency in SportsTaiwan
-
Lotung Poh-Ai HospitalCompletedMetabolic Syndrome | Health Education | Workplace