Infant MalnutritionNCT04504617
Nutrition Education Intervention to Enhance Complementary Feeding Practices Among Infants in Southern Ethiopia
A study testing Nutrition education intervention to enhance complementary feeding practices in people with Infant Malnutrition, run by Texas Tech University at 1 site in Ethiopia.
Trial summary
Child undernutrition is a worldwide public health problem that has persisted in African countries. For instance, the most recently reported prevalence rates of stunting (38%), underweight (24%), and wasting (10%) among children under the age of five in Ethiopia is higher than the global prevalence. Read more about this study
- Who is it for?
- Ages 6 to 23 months
- Conditions the study is for
- Infant Malnutrition
- What is being tested?
- Nutrition education intervention to enhance complementary feeding practices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEthiopia
- Study dates
- 2 Dec 2019to 30 Sep 2020
- 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 23 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant that live in a household that has reside in Arsi Negele, Wondo Genet, and Dale districts for at least one year
- Infants that are within the age of 6 to 23 months at the time of the recruitment
- Infants that live in households where the mother is permanently present
- Infants that live in a household where the mother speaks sidamo or oromio.
Who cannot join
- Infants that live in a household that has reside in Arsi Negele, Wondo Genet, and Dale districts for less than one year
- Infants that are under 6 months or above 23 months of age at the time of the recruitment
- Infants that live in households where the mother is not present
- Infants that live in households where the mother does not speak sidamo or oromio
- Infants that have an illness that require a special nutrition treatment
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Hawassa University
Awasa, Southern Nations, Nationalities, and Peoples' Region
About this study
Official title: A Theory-based Nutrition Education Intervention to Enhance Complementary Feeding Practices Among Young Children in Southern Ethiopia
Child undernutrition is a worldwide public health problem that has persisted in African countries. For instance, the most recently reported prevalence rates of stunting (38%), underweight (24%), and wasting (10%) among children under the age of five in Ethiopia is higher than the global prevalence. The causes of undernutrition are classified in the following manner: immediate causes, such as inadequate dietary intakes; underlying causes, such as household food insecurity and inadequate care and feeding practices; and basic causes, which involve the household's inadequate access to education, employment, and income, among others. Evidence has demonstrated that nutrition education interventions (NEI) may influence both underlying and immediate causes of child undernutrition. For instance, nutrition education interventions have the potential of preventing the underlying causes of child undernutrition by improving mothers' knowledge in care and feeding practices, and further improving the quality and quantity of dietary intake, which is considered an immediate cause of child undernutrition. Moreover, nutrition education interventions designed to improve infant and young child feeding (IYCF) practices, such as dietary diversity, frequency, and adequacy, are considered a high impact strategy that may substantially reduce stunting. Preliminary data from Hawassa University (collaborating institution in this project) demonstrated that approximately 86% of the children residing in Arsi Negele, Wondo Genet, and Dale districts in Oromia and Southern Nations, Nationalities and Peoples' (SNNP) regions in Ethiopia do not receive adequate complementary feeding practices. Such lack of optimal complementary feeding practices may compromise a child's growth, development, and survival. Therefore, there is a critical need for improving child complementary feeding practices to promote their well-being and adequate nutritional status. Thus, the main purpose of this study is to improve child feeding practices and related nutritional status by improving the mother's knowledge, attitudes, and practices (KAP) of complementary feeding practices for their children aged six to 23 months in three woredas located in Oromia and SNNP. It is hypothesized that after the NEI mothers will improve their children' dietary diversity, frequency and adequacy.
Read the detailed description
Elegibility criteria: residents that have lived in Arsi Negele, Wondo Genet, and Dale districts for at least one year, households that have children between 6 and 23 months of age, households where the mother is permanently presents, and households that speak sidamo or oromio.
Exclusion criteria: residents that have lived in Arsi Negele, Wondo Genet, and Dale districts for less than one year, households that have children under 6 months or above 23 months of age, households where the mother is not present, and households that do not speak sidamo.
Outcomes of this study are child feeding practices knowledge, attitudes, dietary diversity score, meal frequency score, adequacy diet score, continuing breastfeeding, maternal dietary diversity, and prevalence of stunting, wasting, and underweight.
- Conditions
- Infant Malnutrition
- Being tested
- Nutrition education intervention to enhance complementary feeding practices
- Keywords
- Infant undernutrition, Complementary feeding
- Medical subject headings
- Infant Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition education intervention to enhance complementary feeding practicesBehavioural
The intervention consist of a six-week nutrition education intervention developed following the DESIGN procedure and the Socio-Cognitive Theory. The intervention consisted of six three-hour weekly sessions that covered topics such as 1) importance and benefits of exclusive and continuing breastfeeding; 2) nutrition for lactating mothers; 3) importance and benefits of complementary feeding practices; 4) risks for starting complementary feeding too early or too late; 5) complementary feeding practices for each age group (6-8, 9-11, and 12-24); 6) importance and benefits of dietary diversity; 7) importance of animal-source foods; 8) importance and benefits of following water, sanitation, and hygiene practices; 9) food safety practices when preparing meals; and 10) the recommended hand-washing protocol. Each lesson was designed to provide a lecture, a discussion using counseling cards, a cooking demonstration with tasting session, and key messages.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | This group will consist of six kebeles with a total of 90 pairs of mothers and their children that will receive the nutrition education intervention to enhance complementary feeding practices first. The six lessons will be delivered in a period of 6 weeks. Before the intervention this groups will be assessed with the baseline assessment. After the intervention, this group will be assessed in three time points (post-intervention, follow-up 1 and follow-up 2). Receives: Behavioral: Nutrition education intervention to enhance complementary feeding practices |
| Delayed Intervention Group | Active comparator | This arm will consist of the six kebeles with a total of 90 pairs of mothers and their children that will not receive the intervention immediately. This group will first complete the baseline and the second assessment. After the second assessment, this group will receive the nutrition education intervention to enhance complementary feeding practices. After the intervention, this group will be assessed in two additional time points (post-intervention and follow-up 1). Receives: Behavioral: Nutrition education intervention to enhance complementary feeding practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary diversity score
The dietary diversity score will be measured using the population indicator of minimum dietary diversity score for children aged 6 to 23 months designed by The Who. This measurement assess the consumption of seven food groups through seven yes-no questions. The food groups that are assessed are the following: 1) grains, roots and tubers; 2) legumes and nuts; 3) dairy products (milk, yogurt, cheese); 4) flesh foods (meat, fish, poultry, and organ meats); 5) eggs; 6) vitamin A rich fruit and vegetables; and 7) other fruits and vegetables. The total dietary diversity score for each participant will be the sum of the food groups that were responded with a yes answer. The maximum score possible is seven.
Measured: Six weeks
Meal frequency
The meal frequency of children will be measured using a question that forms part of the Infant Young and Child Feeding Practices questionnaire provided by the WHO. This question assess the number of times that a baby had meals or snacks, other than liquids, through a multiple answer questions. The participating mother has the option to select the meal frequency from one to six times. The average meal frequency will be calculated for those breastfed and non-breastfed children.
Measured: Six weeks
Acceptable diet score
This is an indicator that measures the proportion of children aged 6 to 23 months of age who receive the minimum feeding frequency and minimum dietary diversity. The acceptable diet score will be calculated using the proportion of children that meet the minimum dietary diversity and the minimum meal frequency divided by the total number of children. This score will be calculated for breastfed and non-breastfed children.
Measured: Six weeks
Secondary outcomes (4)
Child feeding knowledge score
The child feeding knowledge score will be assessed using the questions obtained from the FAO Guidelines for assessing nutritional-related knowledge, attitudes, and practices. The section of knowledge includes 7 open-ended questions in which the data collector will ask an open-ended question to the mother and the mother will have to provide a short answer in her own words. The knowledge score per participant will be calculated based on the number of correct answers provided and an average score of participants will be calculated.
Measured: six weeks
Child feeding maternal attitude score
The child feeding maternal attitude score will be assessed using the questions obtained from the FAO Guidelines for assessing nutritional-related knowledge, attitudes, and practices. The section of attitudes includes 7 three-point Likert scale questions. These questions will assess self-confidence, perceived benefits and barriers for providing diversity foods, frequently meals, and continued breastfeeding for their children aged 6 to 23 months. Responses will be codified to calculate an attitude score per participant. Responses will be codified in the following way: "no confident", "not good" and "challenging" as one; "ok/so-so", "you're not sure", and so-so as two; and "good" and "not challenging" as three.
Measured: six weeks
Maternal dietary diversity score
The dietary diversity score will be measured using the Minimum Dietary Diversity for Women (MDD-W). This measurement assess the consumption of 10 food groups through 17 yes-no questions. The food groups that are assessed are the following: 1) grains, white roots, tubers, and plantains; 2) pulses (beans, peas, and lentils); 3) nuts and seeds; 4) dairy; 5) meat, poultry and fish; 6) eggs; 7) dark green leafy vegetables; 8) other vitamin-A rich fruits and vegetables; 9) other vegetables; and 10) other foods. The total dietary diversity score for each participant will be the sum of the food groups that were responded with a yes answer. The maximum score possible is ten.
Measured: six weeks
Nutritional status
WHO Anthro software will be utilized to calculate weight-for-height z-score (WHZ), height-for-age z-score (HAZ), and weight-for-age z-score (WAZ). Then those children that have a -2 standard deviation in their WHZ, HAZ, and WAZ will be categorized as having wasting, stunting, or underweight. The prevalence of these nutritional status categories will be compared before and after the intervention.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start2 Dec 2019
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant MalnutritionStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Collaborators
- Kansas State University, Hawassa University
- Responsible party
- Principal investigator, Mary Murimi, Texas Tech University
- Investigators
- Mary W Murimi, PhD, Principal investigator, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504617
- Sponsor's protocol ID
- IRB2019-664
- Status last verified
- Aug 2020
- First submitted
- 5 Aug 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Theory-based Nutrition Education Intervention to Enhance Complementary Feeding Practices Among Young Children in Southern Ethiopia
- ClinicalTrials.gov ID
- NCT04504617
- Acronym / sponsor ID
- IRB2019-664
- Conditions
- Infant Malnutrition
- Keywords
- Infant undernutrition, Complementary feeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Collaborators
- Kansas State University, Hawassa University
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 7 Aug 2020 (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 a worldwide public health problem that has persisted in African countries. For instance, the most recently reported prevalence rates of stunting (38%), underweight (24%), and wasting (10%) among children under the age of five in Ethiopia is higher than the global prevalence. The causes of undernutrition are classified in the following manner: immediate causes, such as inadequate dietary intakes; underlying causes, such as household food insecurity and inadequate care and feeding practices; and basic causes, which involve the household's inadequate access to education, employment, and income, among others. Evidence has demonstrated that nutrition education interventions (NEI) may influence both underlying and immediate causes of child undernutrition. For instance, nutrition education interventions have the potential of preventing the underlying causes of child undernutrition by improving mothers' knowledge in care and feeding practices, and further improving the quality and quantity of dietary intake, which is considered an immediate cause of child undernutrition. Moreover, nutrition education interventions designed to improve infant and young child feeding (IYCF) practices, such as dietary diversity, frequency, and adequacy, are considered a high impact strategy that may substantially reduce stunting. Preliminary data from Hawassa University (collaborating institution in this project) demonstrated that approximately 86% of the children residing in Arsi Negele, Wondo Genet, and Dale districts in Oromia and Southern Nations, Nationalities and Peoples' (SNNP) regions in Ethiopia do not receive adequate complementary feeding practices. Such lack of optimal complementary feeding practices may compromise a child's growth, development, and survival. Therefore, there is a critical need for improving child complementary feeding practices to promote their well-being and adequate nutritional status. Thus, the main purpose of this study is to improve child feeding practices and related nutritional status by improving the mother's knowledge, attitudes, and practices (KAP) of complementary feeding practices for their children aged six to 23 months in three woredas located in Oromia and SNNP. It is hypothesized that after the NEI mothers will improve their children' dietary diversity, frequency and adequacy.
Detailed description
Elegibility criteria: residents that have lived in Arsi Negele, Wondo Genet, and Dale districts for at least one year, households that have children between 6 and 23 months of age, households where the mother is permanently presents, and households that speak sidamo or oromio.
Exclusion criteria: residents that have lived in Arsi Negele, Wondo Genet, and Dale districts for less than one year, households that have children under 6 months or above 23 months of age, households where the mother is not present, and households that do not speak sidamo.
Outcomes of this study are child feeding practices knowledge, attitudes, dietary diversity score, meal frequency score, adequacy diet score, continuing breastfeeding, maternal dietary diversity, and prevalence of stunting, wasting, and underweight.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Nutrition education intervention to enhance complementary feeding practicesThis group will consist of six kebeles with a total of 90 pairs of mothers and their children that will receive the nutrition education intervention to enhance complementary feeding practices first. The six lessons will be delivered in a period of 6 weeks. Before the intervention this groups will be assessed with the baseline assessment. After the intervention, this group will be assessed in three time points (post-intervention, follow-up 1 and follow-up 2). |
| Delayed Intervention Group | Active comparator | Behavioral: Nutrition education intervention to enhance complementary feeding practicesThis arm will consist of the six kebeles with a total of 90 pairs of mothers and their children that will not receive the intervention immediately. This group will first complete the baseline and the second assessment. After the second assessment, this group will receive the nutrition education intervention to enhance complementary feeding practices. After the intervention, this group will be assessed in two additional time points (post-intervention and follow-up 1). |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infant that live in a household that has reside in Arsi Negele, Wondo Genet, and Dale districts for at least one year
- Infants that are within the age of 6 to 23 months at the time of the recruitment
- Infants that live in households where the mother is permanently present
- Infants that live in a household where the mother speaks sidamo or oromio.
Key exclusion criteria (5 listed)
- Infants that live in a household that has reside in Arsi Negele, Wondo Genet, and Dale districts for less than one year
- Infants that are under 6 months or above 23 months of age at the time of the recruitment
- Infants that live in households where the mother is not present
- Infants that live in households where the mother does not speak sidamo or oromio
- Infants that have an illness that require a special nutrition treatment
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 education intervention to enhance complementary feeding practicesThe intervention consist of a six-week nutrition education intervention developed following the DESIGN procedure and the Socio-Cognitive Theory. The intervention consisted of six three-hour weekly sessions that covered topics such as 1) importance and benefits of exclusive and continuing breastfeeding; 2) nutrition for lactating mothers; 3) importance and benefits of complementary feeding practices; 4) risks for starting complementary feeding too early or too late; 5) complementary feeding practices for each age group (6-8, 9-11, and 12-24); 6) importance and benefits of dietary diversity; 7) importance of animal-source foods; 8) importance and benefits of following water, sanitation, and hygiene practices; 9) food safety practices when preparing meals; and 10) the recommended hand-washing protocol. Each lesson was designed to provide a lecture, a discussion using counseling cards, a cooking demonstration with tasting session, and key messages. | Behavioural | Delayed Intervention Group, Intervention Group |
Primary outcome
Dietary diversity score
Time frame: Six weeks
The dietary diversity score will be measured using the population indicator of minimum dietary diversity score for children aged 6 to 23 months designed by The Who. This measurement assess the consumption of seven food groups through seven yes-no questions. The food groups that are assessed are the following: 1) grains, roots and tubers; 2) legumes and nuts; 3) dairy products (milk, yogurt, cheese); 4) flesh foods (meat, fish, poultry, and organ meats); 5) eggs; 6) vitamin A rich fruit and vegetables; and 7) other fruits and vegetables. The total dietary diversity score for each participant will be the sum of the food groups that were responded with a yes answer. The maximum score possible is seven.
Meal frequency
Time frame: Six weeks
The meal frequency of children will be measured using a question that forms part of the Infant Young and Child Feeding Practices questionnaire provided by the WHO. This question assess the number of times that a baby had meals or snacks, other than liquids, through a multiple answer questions. The participating mother has the option to select the meal frequency from one to six times. The average meal frequency will be calculated for those breastfed and non-breastfed children.
Acceptable diet score
Time frame: Six weeks
This is an indicator that measures the proportion of children aged 6 to 23 months of age who receive the minimum feeding frequency and minimum dietary diversity. The acceptable diet score will be calculated using the proportion of children that meet the minimum dietary diversity and the minimum meal frequency divided by the total number of children. This score will be calculated for breastfed and non-breastfed children.
4 secondary outcomes
Child feeding knowledge score
Time frame: six weeks
Child feeding maternal attitude score
Time frame: six weeks
Maternal dietary diversity score
Time frame: six weeks
Nutritional status
Time frame: six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- 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.
Mary W Murimi, PhD principal investigator
Texas Tech 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 intervention to enhance complementary feeding practices in people with Infant Malnutrition, run by Texas Tech 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Aug 2020. 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?
Results are not available in the source record.
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?
Dietary diversity score (time frame: Six weeks). 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?
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 7 Aug 2020.