- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05503654
To Evaluate the Effect of Nutrition Education on Infants and Young Children's Nutritional and Health Status in East Wollaga Zone
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
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oromiya
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Jimma, Oromiya, Ethiopia, 378
- Jimma university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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Those interventional groups will take nutrition education by Gada System leaders for 6 consecutive months
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NO_INTERVENTION: Control group
Control Arm is an arm to which the intervention will not be implemented.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optimal Complementary feeding practices (i.e.. Timely introduction of complementary food, Minimum dietary diversity, minimum meal frequency, and minimum acceptable diet)
Time Frame: 6 months of intervention
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The questionnaire will be used to assess the outcome measures in line with the following point
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6 months of intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
linear growth
Time Frame: 6 months of intervention
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Increase in linear growth (cm) after intervention
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6 months of intervention
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Morbidity status
Time Frame: 6 months of intervention
|
The questionnaire will be used to assess the outcome measures in line with the following point: Episodes of diarrhea, fever, and pneumonia within the past 6 months
|
6 months of intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tadele Amente, Jimma university
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 10082022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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