NCT05503654

To Evaluate the Effect of Nutrition Education on Infants and Young Children's Nutritional and Health Status in East Wollaga Zone

Completed NA Last updated 27 March 2025

What this trial tests

NA trial testing Nutrition education in Education on Feeding and Health Status in 520 participants. Completed in 11 May 2023.

Timeline

19 September 2022

Primary endpoint
30 October 2022

11 May 2023

Quick facts

Lead sponsor	Jimma University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	520
Start date	19 September 2022
Primary completion	30 October 2022
Estimated completion	11 May 2023
Sites	1 location across Ethiopia

Drugs / interventions tested

• Nutrition education

Conditions studied

• Education on Feeding and Health Status — all drugs for Education on Feeding and Health Status →

Sponsor

Jimma University

Who can join

Adults 6 Months to 24 Months, any sex, with Education on Feeding and Health Status. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Child undernutrition is the principal cause of child morbidity and mortality worldwide. It manifests in different forms including stunting, wasting, underweight, and micronutrient deficiencies. Globally, in 2020 it is estimated that 149.2 million of children under 5 years of age were affected by stunting, 45.4 million were suffering from wasting and 38.9 million were overweight. The actual figures, particularly for stunting and wasting, are expected to be higher due to the effects of the COVID-19 pandemic.

In spite of WHO and UNICEF recommendations on infants and young child feeding globally, 31% of children 6-8 months have not yet begun to eat complementary foods, and 81% of children aged 6-23 months are not fed the minimum acceptable diet (MAD). Inappropriate infant and young child feeding are a key causal factor in the development of malnutrition that increases the risk of undernutrition, illness, and mortality in infants and young children under five years, even more, severe in those less than 2 years of age because over two third of malnutrition is associated with inappropriate feeding practices during the first year of life.

The first two years of life provide a critical window of opportunity for ensuring appropriate growth and development of children from generation to generation through optimal feeding. Therefore, the aim of this study is to evaluate the effectiveness of nutrition education delivered through Gada System leaders on nutrition and the health status of infants and young children.

A Cluster randomized controlled trial design with two parallel arms among caregivers of infants and young children aged less than two years will be employed in East Wallaga Zone, Western Oromia, Ethiopia from October 01/2021 to November 30/2023. The intervention duration will be 6 months. A total of 566 mother-child dyads will be selected from eighteen kebeles via multi-stage cluster sampling methods. Pre-tested, structured, and interviewer-administered questionnaire will be used to collect data by trained data collectors. The collected data will be cleaned and checked for completeness, then enter into EpiData version 4.1 software to minimize error, then export to SPSS version 25 software for further analysis. Descriptive statistics and advanced analytics models including GEE and LMM will be used by checking the necessary assumption for each model.

The output of the study findings could be useful for health and nutrition policymakers and other concerned bodies in decision making and to design effective intervention strategies to improve feeding practices thus mitigating child malnutrition and improving their health and growth. The total budget required to conduct the study will be 7,420 US dollar

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Social-demographic and behavioral predictors of core indicators of complementary feeding practices among mothers of children aged 6-23 months: baseline results from a cluster-randomized trial in rural Ethiopia.
   Amente T, Kebede Y, Belachew T. · · 2025 · PMID 40604526 · DOI 10.1186/s12887-025-05869-1