NCT05503654

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 19, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2023

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

August 11, 2022

Last Update Submit

March 26, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline survey

  • 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.

    6 months of intervention

Secondary Outcomes (2)

  • Child growth

    6 months of intervention

  • Morbidity status

    6 months of intervention

Study Arms (2)

intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

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

intervention group

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jimma University

Jimma, Oromiya, 378, Ethiopia

Location

MeSH Terms

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Tadele Amente

    Jimma University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A two-arm parallel cluster randomized community trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2022

First Posted

August 17, 2022

Study Start

September 19, 2022

Primary Completion

October 30, 2022

Study Completion

May 11, 2023

Last Updated

March 27, 2025

Record last verified: 2025-03

Locations