BehaviorNCT02249286
Integrating Nutrition Education & Household Food Production for Child Nutrition
A study testing Child Centered Nutrition Counseling in people with Behavior, run by Jimma University.
Trial summary
In Ethiopia, a child-centered counseling approach is hypothesized to be more effective than the current nutrition and health education when investment on home-based food production is used as a platform for nutrition education. Read more about this study
- Who is it for?
- Ages 3 to 12 months
- Conditions the study is for
- Behavior
- What is being tested?
- Child Centered Nutrition Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Oct 2015
- 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 3 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infants less than 12 month
- are permanent residents in the area;
- have no plan to move away during the intervention period;
- are willing to adopt the agriculture activities; and
- have adequate place and time to adopt developed gardens \& backyard poultry production
Who cannot join
- infants with severe acute malnutrition warranting referral to nutrition rehabilitation program with Ready-To-Use Therapeutic foods
- severely ill infants with clinical complications warranting hospital referral; and
- infants with obvious congenital or chronic abnormalities that impair feeding or physical growth measurements.
About this study
Official title: Child-Centred Counselling and Home-Based Food Production to Improve Dietary Adequacy and Growth of Young Children in Southwest Ethiopia
In Ethiopia, a child-centered counseling approach is hypothesized to be more effective than the current nutrition and health education when investment on home-based food production is used as a platform for nutrition education. This project is proposed to evaluate the efficacy of a food-based package integrating child-centered nutrition counseling and home-based food production using a between-group comparative intervention study. The intervention comprises child-centered nutrition counseling for caretakers and support for 'developed' gardens and improved backyard poultry production.
Read the detailed description
Growth faltering among Ethiopian infants and young children is one of the highest in sub-Saharan Africa. Nutrition education on infant and young child feeding has shown good potential to improve growth of young children whenever it is accessible, context-based and integrated with locally available resources. The current nutrition education in Ethiopia, however, appears to be general and lacks the essential components for success. It is mainly didactic and lacks a motivational approach that can enhance the self-efficacy of mothers for behavior change. Another important barrier for nutrition education to become effective is that rural mothers have limited access to nutrient-dense foods that are recommended to be fed to young children. Therefore, it is expected that low food access by poor households together with the less motivational approach used may hamper the effectiveness of the current nutrition education in the country. In Ethiopia, a child-centered counseling approach is hypothesized to be more effective than the current nutrition and health education when investment on home-based food production is used as a platform for nutrition education. This project is proposed to evaluate the efficacy of a food-based package integrating child-centered nutrition counseling and home-based food production using a between-group comparative intervention study. The intervention comprises child-centered nutrition counseling for caretakers and support for 'developed' gardens and improved backyard poultry production; whereas the control will only receive the agriculture extension and the existing health and nutrition education in the area. Two Primary Healthcare Units (one intervention and one control group) will be selected from Jimma Zone using relevant criteria. A total of 404 (i.e. 202 in each of intervention and control areas) households with infants of age < 12 months will participate in the study for 18 months. The efficacy of the intervention will be assessed by its effect on child growth and infant and child feeding index as primary outcomes. Besides the effect on dietary adequacy and growth, the project aims at evaluating the interactive processes in a longitudinal way to provide evidence on the possible success factors and barriers encountered. Therefore, secondary outcomes include household production, income and expenditure in relation to the home-based food production; diet diversity; feeding and care practices, and morbidity. Data will be compared between intervention and control groups using linear mixed-effects models and generalized linear models.
- Conditions
- Behavior
- Being tested
- Child Centered Nutrition Counseling, no intervention
- Keywords
- Child Centered Counseling, Home based food production, Nutrition, Health, IYCF
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child Centered Nutrition CounselingBehavioural
The intervention comprises child-centered nutrition counseling for caretakers and support for 'developed' gardens and improved backyard poultry production; whereas the control will only receive the agriculture extension and the existing health and nutrition education in the area
no interventionOther
the control will only receive the agriculture extension and the existing health and nutrition education in the area
| Study group | Role | What they receive |
|---|---|---|
| Child Centered Nutrition Counseling | Experimental | The intervention comprises child-centered nutrition counseling for caretakers and support for 'developed' gardens and improved backyard poultry production. Receives: Behavioral: Child Centered Nutrition Counseling; Other: no intervention |
| No intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child growth [-Prevalence of stunting ][<-2SD]
prevalence of stunting will be determined by height for age (Ht/Age) using height /length measured in the recumbent position to the nearest 0.1 cm using a measuring board with an upright wooden base and movable headpiece. as well actual age of child will be taken and expressed in terms of Z score.
Measured: baseline,18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jimma University
- Sponsor type
- University, hospital or other
- Collaborators
- Nestlé Foundation, Flemish Interuniversity Council (VLIR)
- Responsible party
- Principal investigator, Abebe Gebremariam, Jimma University
- Investigators
- Abebe Gebremariam, Professor, Principal investigator, Jimma UniversityAlemayehu Argaw, Mr, Principal investigator, Jimma UniversityLieven Huybregts, Dr, Principal investigator, University GhentPatrick Kolsteren, Professor, Principal investigator, University GhentMulusew Gerbaba, Mr., Principal investigator, Jimma UniversitySolomon Demeke, Professor, Principal investigator, Jimma UniversityJoep Grosemans, Mr., Principal investigator, Provincial university college LimburgAmanuel Tesfay, Mr., Principal investigator, Jimma University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249286
- Sponsor's protocol ID
- CCC-HFP
- Status last verified
- Mar 2016
- First submitted
- 5 Sep 2014
- Last updated
- 7 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Child-Centred Counselling and Home-Based Food Production to Improve Dietary Adequacy and Growth of Young Children in Southwest Ethiopia
- ClinicalTrials.gov ID
- NCT02249286
- Acronym / sponsor ID
- CCC-HFP
- Conditions
- Behavior
- Keywords
- Child Centered Counseling, Home based food production, Nutrition, Health, IYCF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Jimma UniversityUniversity, hospital or other
- Collaborators
- Nestlé Foundation, Flemish Interuniversity Council (VLIR)
- Study start
- Jan 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 25 Sep 2014 (estimated)
- 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.
In Ethiopia, a child-centered counseling approach is hypothesized to be more effective than the current nutrition and health education when investment on home-based food production is used as a platform for nutrition education. This project is proposed to evaluate the efficacy of a food-based package integrating child-centered nutrition counseling and home-based food production using a between-group comparative intervention study. The intervention comprises child-centered nutrition counseling for caretakers and support for 'developed' gardens and improved backyard poultry production.
Detailed description
Growth faltering among Ethiopian infants and young children is one of the highest in sub-Saharan Africa. Nutrition education on infant and young child feeding has shown good potential to improve growth of young children whenever it is accessible, context-based and integrated with locally available resources. The current nutrition education in Ethiopia, however, appears to be general and lacks the essential components for success. It is mainly didactic and lacks a motivational approach that can enhance the self-efficacy of mothers for behavior change. Another important barrier for nutrition education to become effective is that rural mothers have limited access to nutrient-dense foods that are recommended to be fed to young children. Therefore, it is expected that low food access by poor households together with the less motivational approach used may hamper the effectiveness of the current nutrition education in the country. In Ethiopia, a child-centered counseling approach is hypothesized to be more effective than the current nutrition and health education when investment on home-based food production is used as a platform for nutrition education. This project is proposed to evaluate the efficacy of a food-based package integrating child-centered nutrition counseling and home-based food production using a between-group comparative intervention study. The intervention comprises child-centered nutrition counseling for caretakers and support for 'developed' gardens and improved backyard poultry production; whereas the control will only receive the agriculture extension and the existing health and nutrition education in the area. Two Primary Healthcare Units (one intervention and one control group) will be selected from Jimma Zone using relevant criteria. A total of 404 (i.e. 202 in each of intervention and control areas) households with infants of age < 12 months will participate in the study for 18 months. The efficacy of the intervention will be assessed by its effect on child growth and infant and child feeding index as primary outcomes. Besides the effect on dietary adequacy and growth, the project aims at evaluating the interactive processes in a longitudinal way to provide evidence on the possible success factors and barriers encountered. Therefore, secondary outcomes include household production, income and expenditure in relation to the home-based food production; diet diversity; feeding and care practices, and morbidity. Data will be compared between intervention and control groups using linear mixed-effects models and generalized linear models.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Child Centered Nutrition Counseling | Experimental | Behavioral: Child Centered Nutrition Counseling, Other: no interventionThe intervention comprises child-centered nutrition counseling for caretakers and support for 'developed' gardens and improved backyard poultry production. |
| No intervention | No intervention | – |
Who may qualify
- Ages
- 3 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- infants less than 12 month
- are permanent residents in the area;
- have no plan to move away during the intervention period;
- are willing to adopt the agriculture activities; and
- have adequate place and time to adopt developed gardens \& backyard poultry production
Key exclusion criteria (3 listed)
- infants with severe acute malnutrition warranting referral to nutrition rehabilitation program with Ready-To-Use Therapeutic foods
- severely ill infants with clinical complications warranting hospital referral; and
- infants with obvious congenital or chronic abnormalities that impair feeding or physical growth measurements.
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 |
|---|---|---|
| Child Centered Nutrition CounselingThe intervention comprises child-centered nutrition counseling for caretakers and support for 'developed' gardens and improved backyard poultry production; whereas the control will only receive the agriculture extension and the existing health and nutrition education in the area | Behavioural | Child Centered Nutrition Counseling |
| no interventionthe control will only receive the agriculture extension and the existing health and nutrition education in the area | Other | Child Centered Nutrition Counseling |
Primary outcome
Child growth [-Prevalence of stunting ][<-2SD]
Time frame: baseline,18 month
prevalence of stunting will be determined by height for age (Ht/Age) using height /length measured in the recumbent position to the nearest 0.1 cm using a measuring board with an upright wooden base and movable headpiece. as well actual age of child will be taken and expressed in terms of Z score.
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 7 Mar 2016.
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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.
Abebe Gebremariam, Professor principal investigator
Jimma University
Alemayehu Argaw, Mr principal investigator
Jimma University
Lieven Huybregts, Dr principal investigator
University Ghent
Questions about this trial
What is this clinical trial studying?
A study testing Child Centered Nutrition Counseling in people with Behavior, run by Jimma University.
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 5 inclusion and 3 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 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Child growth [-Prevalence of stunting ][<-2SD] (time frame: baseline,18 month). 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 Mar 2016.