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Clinical Trials/NCT05503654
NCT05503654
Completed
Not Applicable

Effect of Nutrition Education Delivered Through Gada System Leaders on Nutrition and Health Status of Infants and Young Child in East Wollega Zone, Oromiya Regional State, Western Ethiopia: a Cluster Randomized Controlled Trial

Jimma University1 site in 1 country520 target enrollmentSeptember 19, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Education on Feeding and Health Status
Sponsor
Jimma University
Enrollment
520
Locations
1
Primary Endpoint
Minimum Dietary diversity score
Status
Completed
Last Updated
last year

Overview

Brief 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

Registry
clinicaltrials.gov
Start Date
September 19, 2022
End Date
May 11, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tadele Amente

Principal Investigator

Jimma University

Eligibility Criteria

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

  • 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.

Outcomes

Primary Outcomes

Minimum Dietary diversity score

Time Frame: 6 months of intervention

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.

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

Time Frame: Baseline survey

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.

Secondary Outcomes

  • Child growth(6 months of intervention)
  • Morbidity status(6 months of intervention)

Study Sites (1)

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