Feeding BehaviorNCT03488680
Effectiveness of Behavior Change Communication in Improving Feeding Practices, Nutritional and Health Status of Infants
A study testing Behavior change communication in people with Feeding Behavior and Nutritional Status, run by Jimma University at 1 site in Ethiopia.
Trial summary
Child under nutrition is a major risk factor for ill health and mortality, contributes substantially to the burden of disease in low-income and middle-income countries and is associated with close to half of all child deaths. The prevalence of both underweight and stunting is highest in Africa and South-Central Asia. Read more about this study
- Who is it for?
- Ages 1 month to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Feeding Behavior, Nutritional Status, Morbidity
- What is being tested?
- Behavior change communication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 1 siteEthiopia
- Study dates
- 9 May 2016to 6 Oct 2017
- 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 1 month to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All infants aged 0-6 months at the time of baseline survey,
- Residents in the sampled villages
Who cannot join
- Mother who are ill and unable to communicate
- Infants with birth defects, impaired feeding and ill at the time of baseline survey.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Behavior Change Communication on Optimal Complementary Feeding Through Community Level Actors in Improving Feeding Practices, Nutritional and Health Status of Infants in West Gojjam Zone, Northwest Ethiopia
Child under nutrition is a major risk factor for ill health and mortality, contributes substantially to the burden of disease in low-income and middle-income countries and is associated with close to half of all child deaths. The prevalence of both underweight and stunting is highest in Africa and South-Central Asia. Ethiopia is one of the poorest countries in Sub- Saharan Africa, and child malnutrition is a serious public health problem where the rates for stunting (40%), underweight (25%) and wasting (9%) among children under 5 years are among the highest in the world.
Globally, about 40% of child mortality less than two years is associated with inappropriate feeding practices. Optimal breastfeeding and appropriate complementary feeding could prevent 13% and 6% under-five mortality, respectively. 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 provides a critical window of opportunity for ensuring appropriate growth and development of children from generation to generation through optimal feeding. Hence, the objective of this study to evaluate the effectiveness of behavior change communication on optimal complementary feeding through community level actors in improving feeding practice, health and nutritional status of infants.
A cluster-randomized controlled trial which was conducted in West Gojjam Zone, Northwest Ethiopia from May 9, 2016 to October, 2017. Behavior change communication on complementary feeding was conducted in the intervention kebeles/villages for 8 months. A validated interviewer administered structured questionnaire was used for collecting information on the study subjects both at the baseline and after intervention. Data will be checked, coded and double entered using EPI info and exported to SPSS version 21 for statistical analysis.
The output of the study findings could be useful for health and nutrition policy makers 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 needed to conduct the study is 7,000 US dollar.
Read the detailed description
Globally, about 40% of death children less than two years is associated with inappropriate feeding practices. Optimal breastfeeding and appropriate complementary feeding could prevent 13% and 6% under-five mortality, respectively. Over two third of malnutrition is associated with inappropriate feeding practices during the first year of life.
Every day, 3000-4000 infants die in the developing world from diarrhea and acute respiratory infections because they are given inadequate amounts of breast milk. More than 10 million children die each year in sub- Saharan Africa and South Asia. A major contributor to their deaths is poor breastfeeding practice. The risk of death from diarrhea of partially breastfed infants 0 - 6 months of age was 8.6 times the risk for exclusively breastfed children.
Infant and young feeding practices for infant and young children worldwide are not optimal. It is only 34.8% of infants are exclusively breastfed worldwide. Complementary foods are often introduced too early or too late and are often nutritionally inadequate or unsafe. Only about 39% of infants in the developing countries, 25% in Africa are exclusively breastfed for the first six months and 6% of infants in developing countries are never breastfed.
A wide range of harmful infant and young child feeding practices were documented in Ethiopia. According to EDHS of 2011, 52% of infants started breastfeeding within one hour of birth and exclusive breastfeeding during the first six months with the 4.2 months mean duration of exclusive breastfeeding. About half (49%) of children aged 6-8 months consumed solid, semi-solid, or soft foods and 5% of children were fed minimum dietary diversity and 4% of children fed minimum meal frequency per day while 96% of children continued breastfeeding at one year, and 82% continued at 2 year. Only 4% of children 6 - 23 months living with their mothers are fed in accordance with infant and young child feeding practices and 66% children under the age of two receive age-appropriate breastfeeding. Overall, nearly three children in every ten (27%) are given prelacteal feeds within the first three days of life.
In Amhara region, 38% of infants started breastfeeding within one hour of birth while only 2% and 34% of children 6-24 months were fed according to the minimum standards with respect to food diversity (four or more food groups) and meal frequency.
Sub-optimal infant and young child feeding practices are associated with caretakers' poor knowledge, lack of information and being restricted by traditional beliefs. It is essential to give caregivers necessary knowledge and information to alter their inappropriate feeding behaviors. Promotion of appropriate feeding practices, therefore, is fundamentally important in reducing child malnutrition and mortality and, thus, for achieving MDG 1. In order to sustain the gains made by promoting exclusive breastfeeding for the first six months of life, interventions need to extend into the second half of infancy and beyond. This could be ensured by enabling caregivers to appropriately feed their children with safe and adequate complementary foods while maintaining frequent breastfeeding.
Several efforts to improve the feeding status of the infant and young children have been carried out at different times. The Ethiopian government developed the infant and young child feeding guideline in 2004 following WHO recommendations of global strategy for feeding infants and young children for proper nutrition \& health. Community based nutrition program was also designed to build upon the HEP packages and implemented in all agrarian regions of Ethiopia. However, these efforts have failed to bring about substantive and sustainable changes leading to improvement of infant and young child feeding practices since efforts (nutrition actions) were not based on the evidence on existing feeding practices and what works and what does not. Moreover, the health extension workers were not effectively networked with the community volunteers, work load for health extension workers and lack of training and supervision outcomes could factor their effects on the feeding practices.
As a result, the problem of stunting has remained pervasively high in the country. The government has designed an accelerated stunting reduction program under the revised national nutrition program. Moreover the Federal Ministry of Health has made reduction of child malnutrition in Ethiopia a priority flagship program under the commitment to the Seqota declaration, which states zero level hunger among under two children by 2030. Therefore, the aim of this study is to evaluate the effectiveness of behavior change communication on optimal complementary feeding through community level actors in improving feeding practice, nutrition and health status of infants.
- Conditions
- Feeding Behavior, Nutritional Status, Morbidity
- Being tested
- Behavior change communication
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior change communicationBehavioural
Behavior change communication about optimal complementary feeding
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Behavior change communication Receives: Behavioral: Behavior change communication |
| Control group | No intervention | No Behavior change communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear growth
Increase in linear growth (cm) after intervention
Measured: 8 months of intevention
Secondary outcomes (3)
Dietary diversity score
Dietary diversity score ranges from 1-7; dietary diversity score of greater than or equal to 4 will be considered as optimal.
Measured: 8 months of intervention
Health status
Any form of morbidity in the last two weeks before the study
Measured: 8 months of intervention
Time of initiation of complementary food
Time of initiation of complementary food after intervention
Measured: 8 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 posted5 Apr 2018
- Study start9 May 2016
- Primary completion17 Aug 2017
- Study completion6 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- None (open label)
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jimma University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chalachew Abiyu, Jimma University
- Investigators
- Chalachew Abiyu, MSc, Principal investigator, Jimma University, Jimma, Ethiopia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488680
- Sponsor's protocol ID
- RP144107
- Status last verified
- Apr 2018
- First submitted
- 14 Jun 2016
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Sun J, Dai Y, Zhang S, Huang J, Yang Z, Huo J, Chen C. Implementation of a programme to market a complementary food supplement (Ying Yang Bao) and impacts on anaemia and feeding practices in Shanxi, China. Matern Child Nutr. 2011 Oct;7 Suppl 3(Suppl 3):96-111. doi: 10.1111/j.1740-8709.2011.00353.x.
PubMed 21929638Ayalew CA, Belachew T. Effect of complementary feeding behaviour change communication delivered through community-level actors on infant growth and morbidity in rural communities of West Gojjam Zone, Northwest Ethiopia: A cluster-randomized controlled trial. Matern Child Nutr. 2021 Jul;17(3):e13136. doi: 10.1111/mcn.13136. Epub 2021 Jan 6.
PubMed 33403819Abiyu C, Belachew T. Effect of complementary feeding behavior change communication delivered through community-level actors on the time of initiation of complementary foods in rural communities of West Gojjam zone, Northwest Ethiopia: a cluster-randomized controlled trial. BMC Pediatr. 2020 Nov 5;20(1):509. doi: 10.1186/s12887-020-02396-z.
PubMed 33153434Abiyu C, Belachew T. Effect of complementary feeding behavior change communication delivered through community-level actors on dietary adequacy of infants in rural communities of West Gojjam Zone, Northwest Ethiopia: A cluster-randomized controlled trial. PLoS One. 2020 Sep 3;15(9):e0238355. doi: 10.1371/journal.pone.0238355. eCollection 2020.
PubMed 32881945
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Behavior Change Communication on Optimal Complementary Feeding Through Community Level Actors in Improving Feeding Practices, Nutritional and Health Status of Infants in West Gojjam Zone, Northwest Ethiopia
- ClinicalTrials.gov ID
- NCT03488680
- Acronym / sponsor ID
- RP144107
- Conditions
- Feeding Behavior, Nutritional Status, Morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Jimma UniversityUniversity, hospital or other
- Study start
- 9 May 2016 (actual)
- Primary completion
- 17 Aug 2017 (actual)
- Study completion
- 6 Oct 2017 (actual)
- First posted
- 5 Apr 2018 (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 under nutrition is a major risk factor for ill health and mortality, contributes substantially to the burden of disease in low-income and middle-income countries and is associated with close to half of all child deaths. The prevalence of both underweight and stunting is highest in Africa and South-Central Asia. Ethiopia is one of the poorest countries in Sub- Saharan Africa, and child malnutrition is a serious public health problem where the rates for stunting (40%), underweight (25%) and wasting (9%) among children under 5 years are among the highest in the world.
Globally, about 40% of child mortality less than two years is associated with inappropriate feeding practices. Optimal breastfeeding and appropriate complementary feeding could prevent 13% and 6% under-five mortality, respectively. Over two third of malnutrition is associated with inappropriate feeding practices during the first year of life.
The first two years of life provides a critical window of opportunity for ensuring appropriate growth and development of children from generation to generation through optimal feeding. Hence, the objective of this study to evaluate the effectiveness of behavior change communication on optimal complementary feeding through community level actors in improving feeding practice, health and nutritional status of infants.
A cluster-randomized controlled trial which was conducted in West Gojjam Zone, Northwest Ethiopia from May 9, 2016 to October, 2017. Behavior change communication on complementary feeding was conducted in the intervention kebeles/villages for 8 months. A validated interviewer administered structured questionnaire was used for collecting information on the study subjects both at the baseline and after intervention. Data will be checked, coded and double entered using EPI info and exported to SPSS version 21 for statistical analysis.
The output of the study findings could be useful for health and nutrition policy makers 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 needed to conduct the study is 7,000 US dollar.
Detailed description
Globally, about 40% of death children less than two years is associated with inappropriate feeding practices. Optimal breastfeeding and appropriate complementary feeding could prevent 13% and 6% under-five mortality, respectively. Over two third of malnutrition is associated with inappropriate feeding practices during the first year of life.
Every day, 3000-4000 infants die in the developing world from diarrhea and acute respiratory infections because they are given inadequate amounts of breast milk. More than 10 million children die each year in sub- Saharan Africa and South Asia. A major contributor to their deaths is poor breastfeeding practice. The risk of death from diarrhea of partially breastfed infants 0 - 6 months of age was 8.6 times the risk for exclusively breastfed children.
Infant and young feeding practices for infant and young children worldwide are not optimal. It is only 34.8% of infants are exclusively breastfed worldwide. Complementary foods are often introduced too early or too late and are often nutritionally inadequate or unsafe. Only about 39% of infants in the developing countries, 25% in Africa are exclusively breastfed for the first six months and 6% of infants in developing countries are never breastfed.
A wide range of harmful infant and young child feeding practices were documented in Ethiopia. According to EDHS of 2011, 52% of infants started breastfeeding within one hour of birth and exclusive breastfeeding during the first six months with the 4.2 months mean duration of exclusive breastfeeding. About half (49%) of children aged 6-8 months consumed solid, semi-solid, or soft foods and 5% of children were fed minimum dietary diversity and 4% of children fed minimum meal frequency per day while 96% of children continued breastfeeding at one year, and 82% continued at 2 year. Only 4% of children 6 - 23 months living with their mothers are fed in accordance with infant and young child feeding practices and 66% children under the age of two receive age-appropriate breastfeeding. Overall, nearly three children in every ten (27%) are given prelacteal feeds within the first three days of life.
In Amhara region, 38% of infants started breastfeeding within one hour of birth while only 2% and 34% of children 6-24 months were fed according to the minimum standards with respect to food diversity (four or more food groups) and meal frequency.
Sub-optimal infant and young child feeding practices are associated with caretakers' poor knowledge, lack of information and being restricted by traditional beliefs. It is essential to give caregivers necessary knowledge and information to alter their inappropriate feeding behaviors. Promotion of appropriate feeding practices, therefore, is fundamentally important in reducing child malnutrition and mortality and, thus, for achieving MDG 1. In order to sustain the gains made by promoting exclusive breastfeeding for the first six months of life, interventions need to extend into the second half of infancy and beyond. This could be ensured by enabling caregivers to appropriately feed their children with safe and adequate complementary foods while maintaining frequent breastfeeding.
Several efforts to improve the feeding status of the infant and young children have been carried out at different times. The Ethiopian government developed the infant and young child feeding guideline in 2004 following WHO recommendations of global strategy for feeding infants and young children for proper nutrition \& health. Community based nutrition program was also designed to build upon the HEP packages and implemented in all agrarian regions of Ethiopia. However, these efforts have failed to bring about substantive and sustainable changes leading to improvement of infant and young child feeding practices since efforts (nutrition actions) were not based on the evidence on existing feeding practices and what works and what does not. Moreover, the health extension workers were not effectively networked with the community volunteers, work load for health extension workers and lack of training and supervision outcomes could factor their effects on the feeding practices.
As a result, the problem of stunting has remained pervasively high in the country. The government has designed an accelerated stunting reduction program under the revised national nutrition program. Moreover the Federal Ministry of Health has made reduction of child malnutrition in Ethiopia a priority flagship program under the commitment to the Seqota declaration, which states zero level hunger among under two children by 2030. Therefore, the aim of this study is to evaluate the effectiveness of behavior change communication on optimal complementary feeding through community level actors in improving feeding practice, nutrition and health status of infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Behavior change communicationBehavior change communication |
| Control group | No intervention | –No Behavior change communication |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All infants aged 0-6 months at the time of baseline survey,
- Residents in the sampled villages
Key exclusion criteria (2 listed)
- Mother who are ill and unable to communicate
- Infants with birth defects, impaired feeding 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 |
|---|---|---|
| Behavior change communicationBehavior change communication about optimal complementary feeding | Behavioural | Intervention group |
Primary outcome
Linear growth
Time frame: 8 months of intevention
Increase in linear growth (cm) after intervention
3 secondary outcomes
Dietary diversity score
Time frame: 8 months of intervention
Health status
Time frame: 8 months of intervention
Time of initiation of complementary food
Time frame: 8 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 5 Apr 2018.
- Background: PubMed 21929638Sun J, Dai Y, Zhang S, Huang J, Yang Z, Huo J, Chen C. Implementation of a programme to market a complementary food supplement (Ying Yang Bao) and impacts on anaemia and feeding practices in Shanxi, China. Matern Child Nutr. 2011 Oct;7 Suppl 3(Suppl 3):96-111. doi: 10.1111/j.1740-8709.2011.00353.x.
- Derived from this study: PubMed 33403819Ayalew CA, Belachew T. Effect of complementary feeding behaviour change communication delivered through community-level actors on infant growth and morbidity in rural communities of West Gojjam Zone, Northwest Ethiopia: A cluster-randomized controlled trial. Matern Child Nutr. 2021 Jul;17(3):e13136. doi: 10.1111/mcn.13136. Epub 2021 Jan 6.
- Derived from this study: PubMed 33153434Abiyu C, Belachew T. Effect of complementary feeding behavior change communication delivered through community-level actors on the time of initiation of complementary foods in rural communities of West Gojjam zone, Northwest Ethiopia: a cluster-randomized controlled trial. BMC Pediatr. 2020 Nov 5;20(1):509. doi: 10.1186/s12887-020-02396-z.
- Derived from this study: PubMed 32881945Abiyu C, Belachew T. Effect of complementary feeding behavior change communication delivered through community-level actors on dietary adequacy of infants in rural communities of West Gojjam Zone, Northwest Ethiopia: A cluster-randomized controlled trial. PLoS One. 2020 Sep 3;15(9):e0238355. doi: 10.1371/journal.pone.0238355. eCollection 2020.
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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.
Chalachew Abiyu, MSc principal investigator
Jimma University, Jimma, Ethiopia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavior change communication in people with Feeding Behavior and Nutritional 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 5 Apr 2018. 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?
Linear growth (time frame: 8 months of intevention). 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 NCT03488680, which also lists 4 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 5 Apr 2018.