Feeding BehaviorACFPNCT05871346
Effects of Complementary Feeding Counseling on Appropriate Complementary Feeding Practices and Child Undernutrition
A study testing Complementary feeding counseling in people with Feeding Behavior, run by Bahir Dar University at 1 site in Ethiopia.
Trial summary
Appropriate complementary feeding practices as per the World Health Organization recommendations is a window of opportunity to promote health and prevent acute and chronic undernutrition (stunting, wasting \& underweight). Read more about this study
- Who is it for?
- Ages 6 to 21 months
- Conditions the study is for
- Feeding Behavior
- What is being tested?
- Complementary feeding counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 776 participants
- Where
- 1 siteEthiopia
- Study dates
- 9 Jun 2023to 30 Dec 2024
- 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 21 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Mothers with severe mental illness or who are unable to communicate (e.g., deaf).
- Mother-child pairs with severe congenital malformations of their children.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Complementary Feeding Counseling on Appropriate Complementary Feeding Practices and Child Undernutrition in West Gojjam Zone, Northwest Ethiopia: Cluster Randomized Controlled Trial
Appropriate complementary feeding practices as per the World Health Organization recommendations is a window of opportunity to promote health and prevent acute and chronic undernutrition (stunting, wasting \& underweight). Globally, the burden of undernutrition remains unacceptably high, and the progress of undernutrition reduction is unsatisfactorily slow. In Ethiopia, appropriate complementary feeding practices of mothers to their children are very low. In contrast, child undernutrition is a major public health problem.
Read the detailed description
Appropriate nutrition during the first 1000 days of life lays the foundation for a child's health and well-being. Introduction of complementary foods within 6-8 months of age and step-wise increase of diversified plant and animal-based diets is necessary, for which exclusive breast milk is no longer enough to meet the nutritional needs. Appropriate complementary feeding practices as per the World Health Organization recommendations is a window of opportunity to promote health and prevent acute and chronic undernutrition (stunting, wasting \& underweight). Globally, the burden of undernutrition remains unacceptably high, and the progress of undernutrition reduction is unsatisfactorily slow. In Ethiopia, appropriate complementary feeding practices of mothers to their children are very low. In contrast, child undernutrition is a major public health problem. This study aims to determine the effects of complementary feeding counseling on appropriate complementary feeding practices and child undernutrition through a community-based randomized controlled trial.
- Conditions
- Feeding Behavior
- Being tested
- Complementary feeding counseling
- Keywords
- Complementary feeding counseling (CFC), Appropriate complementary feeding practices (ACFP), Child Undernutrition
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complementary feeding counselingBehavioural
Complementary Feeding Counseling to Improve Appropriate Complementary Feeding Practices and Reduce Child Undernutrition
| Study group | Role | What they receive |
|---|---|---|
| Complementary Feeding Counseling | Experimental | Complementary feeding counseling to the mother-child pairs, in the intervention clusters, will be given by trained women development army (WDA) team leaders. The intervention process will have two components; training of WDA leaders, and counseling of mothers. Counselors' training will be given centrally by the principal investigator. During counseling, WDA leaders will use a counseling guide, which is prepared in Amharic, the local and the national language. The counseling guide contains seven key messages; complementary feeding: at 6 months, from 6-8 months, from 9-11 months, from 12-23 months, hygiene, breast feeding a sick child greater than 6 months, and signs that require mothers' special care of their children. Starting the children's 6 months of age, participants in the intervention group will receive in group counseling at convenient places, and individual counseling at each mother-child pair's home every month for 9 consecutive months (a total of 9 months follow up). Receives: Behavioral: Complementary feeding counseling |
| Routine Complementary Feeding Counseling | Experimental | Participants in the control clusters will receive the routine complementary feeding counseling, which is offered by heath extension workers and other health professionals. Receives: Behavioral: Complementary feeding counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in appropriate complementary feeding practices of mothers for their children at 9 months.
Questions related to complementary feeding practices will be used to measure these practices of mothers for their children (Appropriate/Inappropriate). To measure appropriate complementary feeding practices, we will follow the World Health Organization recommendations for infant and young child feeding practices, continuation of breastfeeding, starting solid, semi-solid or soft foods at 6 months of age, the eight indicators used to calculate the dietary diversity, and the meal frequency will be asked. Minimum dietary diversity, minimum meal frequency, and consumption of egg and/or flesh food will be determined. Appropriate complementary feeding practice is defined if the four indicators: timely introduction of complementary foods, minimum dietary diversity, minimum meal frequency, and consumption of egg and/or flesh food are fulfilled. Otherwise, inappropriate if a child's feeding practices do not fulfill even one of the components of appropriate complementary feeding practices.
Measured: Time Frame: At baseline (from June 9 to December 30, 2023), and in 9 months (from September 30 to December 30, 2024).
Secondary outcomes (1)
Change from baseline in child nutritional status at 9 months
The child nutritional status (Undernutrition / No Undernutrition) will be determined by measuring the length, weight, and calculating the child's age. Length will be measured using a calibrated length board to the nearest 1mm (0.1cm). Weight will be measured using mechanical hanging scale with weighing pants to the nearest 10g at the time of enrollment and 100g at end-line measurements. Before weighing the child, the weighing scale will be hung securely and set to zero. The child's age will be calculated by subtracting the child's date of birth from the date of baseline data collection. Undernutrition will be defined if a child is considered wasted, or underweight, or stunted. The child is wasted: when the weight-for-length-Z score (WLZ) is <-2 standard deviations; underweight: when weight-for-age Z score (WAZ) is <-2 standard deviations, and stunted: when length-for-age Z score (LAZ) is <-2 standard deviations.
Measured: Time Frame: At baseline (from June 9 to December 30, 2023), and in 9 months (from September 30 to December 30, 2024).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start9 Jun 2023
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Feeding BehaviorStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 776 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahir Dar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiferaw Birhanu Aynalem, MSc, Bahir Dar University
- Investigators
- Shiferaw Bi Aynalem, MSc, Principal investigator, Bahir Dar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871346
- Sponsor's protocol ID
- adenek2195
- Acronym
- ACFP
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2023
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Michaelsen KF, Grummer-Strawn L, Begin F. Emerging issues in complementary feeding: Global aspects. Matern Child Nutr. 2017 Oct;13 Suppl 2(Suppl 2):e12444. doi: 10.1111/mcn.12444.
PubMed 29032617Birhanu S, Alene GD, Demilew YM. Anthropometric Failure and Associated Factors Among Infants Aged 6-8 Months in West Gojjam Zone, Ethiopia. Food Sci Nutr. 2026 Feb 15;14(2):e71548. doi: 10.1002/fsn3.71548. eCollection 2026 Feb.
PubMed 41700133
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Complementary Feeding Counseling on Appropriate Complementary Feeding Practices and Child Undernutrition in West Gojjam Zone, Northwest Ethiopia: Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05871346
- Acronym / sponsor ID
- ACFP / adenek2195
- Conditions
- Feeding Behavior
- Keywords
- Complementary feeding counseling (CFC), Appropriate complementary feeding practices (ACFP), Child Undernutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 776 participants (actual)
- Lead sponsor
- Bahir Dar UniversityUniversity, hospital or other
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 23 May 2023 (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.
Appropriate complementary feeding practices as per the World Health Organization recommendations is a window of opportunity to promote health and prevent acute and chronic undernutrition (stunting, wasting \& underweight). Globally, the burden of undernutrition remains unacceptably high, and the progress of undernutrition reduction is unsatisfactorily slow. In Ethiopia, appropriate complementary feeding practices of mothers to their children are very low. In contrast, child undernutrition is a major public health problem.
Detailed description
Appropriate nutrition during the first 1000 days of life lays the foundation for a child's health and well-being. Introduction of complementary foods within 6-8 months of age and step-wise increase of diversified plant and animal-based diets is necessary, for which exclusive breast milk is no longer enough to meet the nutritional needs. Appropriate complementary feeding practices as per the World Health Organization recommendations is a window of opportunity to promote health and prevent acute and chronic undernutrition (stunting, wasting \& underweight). Globally, the burden of undernutrition remains unacceptably high, and the progress of undernutrition reduction is unsatisfactorily slow. In Ethiopia, appropriate complementary feeding practices of mothers to their children are very low. In contrast, child undernutrition is a major public health problem. This study aims to determine the effects of complementary feeding counseling on appropriate complementary feeding practices and child undernutrition through a community-based randomized controlled trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complementary Feeding Counseling | Experimental | Behavioral: Complementary feeding counselingComplementary feeding counseling to the mother-child pairs, in the intervention clusters, will be given by trained women development army (WDA) team leaders. The intervention process will have two components; training of WDA leaders, and counseling of mothers. Counselors' training will be given centrally by the principal investigator. During counseling, WDA leaders will use a counseling guide, which is prepared in Amharic, the local and the national language. The counseling guide contains seven key messages; complementary feeding: at 6 months, from 6-8 months, from 9-11 months, from 12-23 months, hygiene, breast feeding a sick child greater than 6 months, and signs that require mothers' special care of their children. Starting the children's 6 months of age, participants in the intervention group will receive in group counseling at convenient places, and individual counseling at each mother-child pair's home every month for 9 consecutive months (a total of 9 months follow up). |
| Routine Complementary Feeding Counseling | Experimental | Behavioral: Complementary feeding counselingParticipants in the control clusters will receive the routine complementary feeding counseling, which is offered by heath extension workers and other health professionals. |
Who may qualify
- Ages
- 6 to 21 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Mothers with severe mental illness or who are unable to communicate (e.g., deaf).
- Mother-child pairs with severe congenital malformations of their children.
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 |
|---|---|---|
| Complementary feeding counselingComplementary Feeding Counseling to Improve Appropriate Complementary Feeding Practices and Reduce Child Undernutrition | Behavioural | Complementary Feeding Counseling, Routine Complementary Feeding Counseling |
Primary outcome
Change from baseline in appropriate complementary feeding practices of mothers for their children at 9 months.
Time frame: Time Frame: At baseline (from June 9 to December 30, 2023), and in 9 months (from September 30 to December 30, 2024).
Questions related to complementary feeding practices will be used to measure these practices of mothers for their children (Appropriate/Inappropriate). To measure appropriate complementary feeding practices, we will follow the World Health Organization recommendations for infant and young child feeding practices, continuation of breastfeeding, starting solid, semi-solid or soft foods at 6 months of age, the eight indicators used to calculate the dietary diversity, and the meal frequency will be asked. Minimum dietary diversity, minimum meal frequency, and consumption of egg and/or flesh food will be determined. Appropriate complementary feeding practice is defined if the four indicators: timely introduction of complementary foods, minimum dietary diversity, minimum meal frequency, and consumption of egg and/or flesh food are fulfilled. Otherwise, inappropriate if a child's feeding practices do not fulfill even one of the components of appropriate complementary feeding practices.
1 secondary outcome
Change from baseline in child nutritional status at 9 months
Time frame: Time Frame: At baseline (from June 9 to December 30, 2023), and in 9 months (from September 30 to December 30, 2024).
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 17 Apr 2025.
- Results publication: PubMed 29032617Michaelsen KF, Grummer-Strawn L, Begin F. Emerging issues in complementary feeding: Global aspects. Matern Child Nutr. 2017 Oct;13 Suppl 2(Suppl 2):e12444. doi: 10.1111/mcn.12444.
- Derived from this study: PubMed 41700133Birhanu S, Alene GD, Demilew YM. Anthropometric Failure and Associated Factors Among Infants Aged 6-8 Months in West Gojjam Zone, Ethiopia. Food Sci Nutr. 2026 Feb 15;14(2):e71548. doi: 10.1002/fsn3.71548. eCollection 2026 Feb.
- 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.
Shiferaw Bi Aynalem, MSc principal investigator
Bahir Dar 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 Complementary feeding counseling in people with Feeding Behavior, run by Bahir Dar 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 0 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 17 Apr 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?
Change from baseline in appropriate complementary feeding practices of mothers for their children at 9 months. (time frame: Time Frame: At baseline (from June 9 to December 30, 2023), and in 9 months (from September 30 to December 30, 2024).). 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 NCT05871346, which also lists 2 linked publications.
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 17 Apr 2025.