AnemiaNCT05254717
Effect of Soaking Complementary Foods Flour on Hemoglobin Concentration, Anthropometric Deficits and Episode of Diarrheal, Cough and Fever Morbidities
A study testing counselling in people with Anemia, run by Madda walabu university at 1 site in Ethiopia.
Trial summary
Removing anti nutrient factors using simple cost-effective and sustainable household methods to improve nutritional status of children in communities were plant based complementary foods are the main source of Nutrients is highly recommended. Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- Anemia
- What is being tested?
- counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Nov 2021to 15 May 2022
- 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
- No healthy volunteers
- Child
Who may be able to join
- Voluntarily agreed mothers with children aged 6-23 month
- Mothers with children aged 6-23 month who lived at least six months in the selected communities
- Mothers who have no plan to leave the area within 6 months period
Who cannot join
- • If the child is seriously ill at the time of data collection
- Children with severe anemia hemoglobin level <= 7mg/dl will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Soaking Complementary Foods Flour on Hemoglobin Concentration Level, Anthropometric Deficits and Episode of Diarrheal, Cough and Fever Morbidities of Children Age 6-24 Months
Removing anti nutrient factors using simple cost-effective and sustainable household methods to improve nutritional status of children in communities were plant based complementary foods are the main source of Nutrients is highly recommended. Therefore, the aim of this study is to determine effect of soaking complementary foods on hemoglobin, nutritional and health status of children 6-23 months in agrarian community of bale zone.
Read the detailed description
Objectives of the intervention
- To determine prevalence and associated factors of nutritional status and anemia among children aged 6-23 months in agrarian community of Bale zone
- To Explore the complementary feeding practice knowledge perception of mother with children aged 6-23 months in agrarian community of Bale zone
- To determine effect of soaking complementary foods flour on nutritional status of children aged 6-23 months in agrarian community of Bale Zone
- To determine effect of soaking complementary foods flour on hemoglobin level of children aged 6-23 months in agrarian community of Bale Zone
- To determine effect of soaking complementary foods flour on frequency of morbidity of children aged 6-23 months in agrarian community of Bale Zone
Target groups The target groups for the intervention will be mothers with their children aged 6-23 months in selected Districts of Bale zone and participated in the baseline study.
Following baseline study, the two districts were assigned to be either an intervention or comparison group randomly. While the intervention community received the Nutrition counselling on promotion of complementary flour soaking, the comparison community was monitored for presence of any other intervention that might have a potential to mask the effect of the current intervention in the target. The intervention will be carried out for a period of six months.
End-line data collection included the following major components:
- Dietary Diversity practice
- Anthropometric measurements
- Hemoglobin test
- Conditions
- Anemia
- Being tested
- counselling
- Keywords
- Complementary feeding, soaking Flours, Undernutrition, Anemia
- Medical subject headings
- Anemia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counsellingOther
intervention groups will receive counselling on improving quality of complementary feeding by soaking complementary foods flours and basic methods of soaking complementary flours.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | Following baseline study, the interventional arm assigned to receive counselling intervention on complementary food flour soaking Receives: Other: counselling |
| control arm | No intervention | The control group will be monitored for presence of any other intervention that might have a potential to mask the effect of the current intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
children's blood hemoglobin concentration level
Measured: 15 days post intervention
children's Anthropometric deficits; Wasting (low-weight-for-length), stunting (low-Length-for-age) and underweight (low-weight-for-age)
Measured: 15 days post intervention
children's Episode of Diarrheal, cough and fever Morbidities
Measured: 15 days post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 Nov 2021
- Primary completion1 May 2022
- Study completion15 May 2022
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 AnemiaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Madda walabu university
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mekonnen Tegegne, Madda walabu university
- Investigators
- Tefera Proff. Belachew, PHD, Study director, Dean of School of Graduate Studies, Jimma University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254717
- Sponsor's protocol ID
- MWU
- Status last verified
- Sep 2022
- First submitted
- 2 Feb 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tegegne M, Abate KH, Belechew T. Effect of counselling about complementary food flour soaking on nutritional and health status of children 6-23 months, a quasi-experimental study. Clin Nutr ESPEN. 2025 Apr;66:281-289. doi: 10.1016/j.clnesp.2025.01.038. Epub 2025 Jan 27.
PubMed 39864523
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Soaking Complementary Foods Flour on Hemoglobin Concentration Level, Anthropometric Deficits and Episode of Diarrheal, Cough and Fever Morbidities of Children Age 6-24 Months
- ClinicalTrials.gov ID
- NCT05254717
- Acronym / sponsor ID
- MWU
- Conditions
- Anemia
- Keywords
- Complementary feeding, soaking Flours, Undernutrition, Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Madda walabu universityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 24 Feb 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.
Removing anti nutrient factors using simple cost-effective and sustainable household methods to improve nutritional status of children in communities were plant based complementary foods are the main source of Nutrients is highly recommended. Therefore, the aim of this study is to determine effect of soaking complementary foods on hemoglobin, nutritional and health status of children 6-23 months in agrarian community of bale zone.
Detailed description
Objectives of the intervention
- To determine prevalence and associated factors of nutritional status and anemia among children aged 6-23 months in agrarian community of Bale zone
- To Explore the complementary feeding practice knowledge perception of mother with children aged 6-23 months in agrarian community of Bale zone
- To determine effect of soaking complementary foods flour on nutritional status of children aged 6-23 months in agrarian community of Bale Zone
- To determine effect of soaking complementary foods flour on hemoglobin level of children aged 6-23 months in agrarian community of Bale Zone
- To determine effect of soaking complementary foods flour on frequency of morbidity of children aged 6-23 months in agrarian community of Bale Zone
Target groups The target groups for the intervention will be mothers with their children aged 6-23 months in selected Districts of Bale zone and participated in the baseline study.
Following baseline study, the two districts were assigned to be either an intervention or comparison group randomly. While the intervention community received the Nutrition counselling on promotion of complementary flour soaking, the comparison community was monitored for presence of any other intervention that might have a potential to mask the effect of the current intervention in the target. The intervention will be carried out for a period of six months.
End-line data collection included the following major components:
- Dietary Diversity practice
- Anthropometric measurements
- Hemoglobin test
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Other: counsellingFollowing baseline study, the interventional arm assigned to receive counselling intervention on complementary food flour soaking |
| control arm | No intervention | –The control group will be monitored for presence of any other intervention that might have a potential to mask the effect of the current intervention. |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Voluntarily agreed mothers with children aged 6-23 month
Key exclusion criteria (2 listed)
- • If the child is seriously ill at the time of data collection
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 |
|---|---|---|
| counsellingintervention groups will receive counselling on improving quality of complementary feeding by soaking complementary foods flours and basic methods of soaking complementary flours. | Other | Interventional arm |
Primary outcome
children's blood hemoglobin concentration level
Time frame: 15 days post intervention
children's Anthropometric deficits; Wasting (low-weight-for-length), stunting (low-Length-for-age) and underweight (low-weight-for-age)
Time frame: 15 days post intervention
children's Episode of Diarrheal, cough and fever Morbidities
Time frame: 15 days post 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 14 Sep 2022.
- Derived from this study: PubMed 39864523Tegegne M, Abate KH, Belechew T. Effect of counselling about complementary food flour soaking on nutritional and health status of children 6-23 months, a quasi-experimental study. Clin Nutr ESPEN. 2025 Apr;66:281-289. doi: 10.1016/j.clnesp.2025.01.038. Epub 2025 Jan 27.
- Individual participant dataSharing planned: No
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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.
Tefera Proff. Belachew, PHD study director
Dean of School of Graduate Studies, 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 counselling in people with Anemia, run by Madda walabu 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 3 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 14 Sep 2022. 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?
children's blood hemoglobin concentration level (time frame: 15 days post intervention). The study lists 3 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 NCT05254717, 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 14 Sep 2022.