Clinical trial NCT05503654: To Evaluate the Effect of Nutrition Education on Infants and Young Children's Nutritional and Health Status in East Wollaga Zone
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Education on Feeding and Health Status
Lead sponsor: Jimma University
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 520
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two-arm parallel cluster randomized community trial
Primary purpose: PREVENTION

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


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.

Primary outcomes:
measure: Core indicators of CF.Practices (i.e.. Minimum dietary diversity, minimum meal frequency, and minimum acceptable diet)
timeFrame: Baseline survey
measure: Minimum Dietary diversity score
timeFrame: 6 months of intervention
Secondary outcomes:
measure: Child growth
timeFrame: 6 months of intervention
measure: Morbidity status
timeFrame: 6 months of intervention
Other outcomes:
Locations:
city: Jimma
country: Ethiopia
facility: Jimma University
state: Oromiya
Study officials:
affiliation: Jimma University
name: Tadele Amente
role: PRINCIPAL_INVESTIGATOR
References: