Education on Feeding and Health StatusNCT05503654
To Evaluate the Effect of Nutrition Education on Infants and Young Children's Nutritional and Health Status in East Wollaga Zone
A study testing Nutrition education in people with Education on Feeding and Health Status, run by Jimma University at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Education on Feeding and Health Status
- What is being tested?
- Nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteEthiopia
- Study dates
- 19 Sep 2022to 11 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All infants and young children aged 6-17 months at the time of the baseline survey
- Residents in the sampled kebeles
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- Nutrition education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition educationBehavioural
Those interventional groups will take nutrition education by Gada System leaders for 6 consecutive months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Nutrition education |
| Control group | No intervention | Control Arm is an arm to which the intervention will not be implemented. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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
- 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
- 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.
Measured: 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.
Measured: 6 months of intervention
Secondary outcomes (2)
Child growth
Change in length (cm) and weight(kg) after intervention based on anthropometric measurement. Our target here is to assess the children between 6 and 23 months old; baseline and end-line anthropometric data will be collected from all participants. Child physical growth will be considered an outcome measure, measured by length gain (i.e., end-line minus baseline length in centimeters), and weight gain (i.e, end-line minus baseline weight in kilograms) separately, and reported under one objective separately. The aim is not to create a composite variable like BMI.
Measured: 6 months of intervention
Morbidity status
The questionnaire adopted from the Ethiopian Demographic and Health Survey report of 2016 will be used to assess the outcome variables based on the presence (Yes) or absence (No) of diarrhea, fever, and pneumonia(cough) frequency within the two weeks during baseline and end-line data collection. This may be categorize participants based on the response given.
Measured: 6 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start19 Sep 2022
- Primary completion30 Oct 2022
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Education on Feeding and Health StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-arm parallel cluster randomized community trial
- Masking
- None (open label)
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jimma University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tadele Amente, Jimma University
- Investigators
- Tadele Amente, Principal investigator, Jimma University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503654
- Sponsor's protocol ID
- 10082022
- Status last verified
- Mar 2025
- First submitted
- 11 Aug 2022
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Based on the progress of the study, I will decide to plan for future
Publications
Amente T, Kebede Y, Belachew T. Social-demographic and behavioral predictors of core indicators of complementary feeding practices among mothers of children aged 6-23 months: baseline results from a cluster-randomized trial in rural Ethiopia. BMC Pediatr. 2025 Jul 2;25(1):517. doi: 10.1186/s12887-025-05869-1.
PubMed 40604526
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05503654
- Acronym / sponsor ID
- 10082022
- Conditions
- Education on Feeding and Health Status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Jimma UniversityUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A two-arm parallel cluster randomized community trial
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Nutrition educationIntervention 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. |
| Control group | No intervention | –Control Arm is an arm to which the intervention will not be implemented. |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All infants and young children aged 6-17 months at the time of the baseline survey
- Residents in the sampled kebeles
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition educationThose interventional groups will take nutrition education by Gada System leaders for 6 consecutive months | Behavioural | intervention group |
Primary outcome
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.
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.
2 secondary outcomes
Child growth
Time frame: 6 months of intervention
Morbidity status
Time frame: 6 months of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Derived from this study: PubMed 40604526Amente T, Kebede Y, Belachew T. Social-demographic and behavioral predictors of core indicators of complementary feeding practices among mothers of children aged 6-23 months: baseline results from a cluster-randomized trial in rural Ethiopia. BMC Pediatr. 2025 Jul 2;25(1):517. doi: 10.1186/s12887-025-05869-1.
- Individual participant dataSharing planned: Undecided. Based on the progress of the study, I will decide to plan for future
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tadele Amente principal investigator
Jimma University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition education in people with Education on Feeding and Health Status, run by Jimma University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core indicators of CF.Practices (i.e.. Minimum dietary diversity, minimum meal frequency, and minimum acceptable diet) (time frame: Baseline survey). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05503654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.