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

NCT ID: NCT05503654

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 520 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-19
• Study Completion Date: 2023-05-11

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

Conditions

Education on Feeding and Health Status

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nutrition education

Intervention Type: BEHAVIORAL

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

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nutrition education

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jimma University

OTHER

Sponsor Role: lead

Responsible Party

Tadele Amente

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tadele Amente

Role: PRINCIPAL_INVESTIGATOR

Jimma University

Locations

Jimma University

Jimma, Oromiya, Ethiopia

Countries

Ethiopia

Other Identifiers

10082022

Identifier Type: -

Identifier Source: org_study_id