CClinicalTrials.gg
CompletedNCT05503654Updated Mar 27, 2025

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

An interventional study of Nutrition education in Education on Feeding and Health Status, sponsored by Jimma University. Completed at 1 site in Ethiopia. Open to participants aged 6 Months to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-27.

Sponsored by Jimma University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
520
Allocation
Randomized
Ages
6 Months to 24 Months
Sex
All
01

Study summary

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

02

Conditions studied

  • Education on Feeding and Health Status
03

In context

Lead sponsor

Jimma University is the lead sponsor of 26 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 24 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • All infants and young children aged 6-17 months at the time of the baseline survey
  • Residents in the sampled kebeles

Exclusion criteria

Exclusion Criteria:

  • Mothers who are ill and unable to communicate
  • Infants and young children with birth defects, impaired feeding, twin and ill at the time of baseline survey.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
520 participants (actual)

Study arms

  • Experimental
    intervention group

    Intervention Arm is an arm in which nutrition education will be given to caregivers of infants and young children less than two years aged using the Health Belief Model and Theory of Planned Behavior.

    Behavioral: Nutrition education

  • No intervention
    Control group

    Control Arm is an arm to which the intervention will not be implemented.

Interventions

  • BehavioralNutrition education

    Those interventional groups will take nutrition education by Gada System leaders for 6 consecutive months

06

What researchers measure

Primary outcomes

  1. Core indicators of CF.Practices (i.e.. Minimum dietary diversity, minimum meal frequency, and minimum acceptable diet)

    The developed questionnaire will be categorized according to World Health Organization and United Nations International Children Emergency Fund recommending guideline to assess the outcome variables. 1. Minimum dietary diversity: if the child is between 6-23 months of age consumed equal or greater than 5 food groups from 8 food groups during the previous day 2. Minimum meal frequency: If the children between 6-23 months of age consumed solid, semi-solid, or soft foods (but also including milk feeds for non-breastfed children) at least the minimum number of times(i.e.. 3 for breastfeeding, and 4 for non-breastfeed) during the previous day 3. Minimum acceptable diet: If the children between 6-23 months of age consumed a minimum acceptable diet (i.e. fulfill minimum dietary diversity and minimum meal frequency for breast feed, and non-breastfeed) during the previous day.

    Time frame: Baseline survey

  2. Minimum Dietary diversity score

    From the already developed questionnaire will be used to measure the change of dietary diversity between the baseline assessment and end-line assessment between and within the study groups after intervention according to World Health Organization recommendation guideline to measure the outcome variable.

    Time frame: 6 months of intervention

Secondary outcomes

  1. Child growth

    Change in length (cm) and weight(kg) after intervention based on anthropometric measurement. Our target here is to assess the children between 6 and 23 months old; baseline and end-line anthropometric data will be collected from all participants. Child physical growth will be considered an outcome measure, measured by length gain (i.e., end-line minus baseline length in centimeters), and weight gain (i.e, end-line minus baseline weight in kilograms) separately, and reported under one objective separately. The aim is not to create a composite variable like BMI.

    Time frame: 6 months of intervention

  2. Morbidity status

    The questionnaire adopted from the Ethiopian Demographic and Health Survey report of 2016 will be used to assess the outcome variables based on the presence (Yes) or absence (No) of diarrhea, fever, and pneumonia(cough) frequency within the two weeks during baseline and end-line data collection. This may be categorize participants based on the response given.

    Time frame: 6 months of intervention

07

Study locations

1 site
  • Jimma University
    Jimma, Oromiya 378, Ethiopia
08

References and documents

Individual participant data

Plan to share: Undecided — Based on the progress of the study, I will decide to plan for future

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05503654
Lead sponsor
Jimma University
Responsible party
Tadele Amente (Principal Investigator, Jimma University) — Principal investigator
First posted
Aug 17, 2022
Start date
Sep 19, 2022
Primary completion
Oct 30, 2022
Completion
May 11, 2023
Last update
Mar 27, 2025

Study contacts

Tadele Amente
principal investigator · Jimma University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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