- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02249286
Integrating Nutrition Education & Household Food Production for Child Nutrition
March 4, 2016 updated by: Abebe Gebremariam, Jimma University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
404
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No intervention
|
|
Experimental: Child Centered Nutrition Counseling
The intervention comprises child-centered nutrition counseling for caretakers and support for 'developed' gardens and improved backyard poultry production.
|
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
the control will only receive the agriculture extension and the existing health and nutrition education in the area
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline,18 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Abebe Gebremariam, Professor, Jimma university
- Principal Investigator: Alemayehu Argaw, Mr, Jimma university
- Principal Investigator: Lieven Huybregts, Dr, University Ghent
- Principal Investigator: Patrick Kolsteren, Professor, University Ghent
- Principal Investigator: Mulusew Gerbaba, Mr., Jimma university
- Principal Investigator: Solomon Demeke, Professor, Jimma university
- Principal Investigator: Joep Grosemans, Mr., Provincial university college Limburg
- Principal Investigator: Amanuel Tesfay, Mr., Jimma university
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
September 5, 2014
First Submitted That Met QC Criteria
September 23, 2014
First Posted (Estimate)
September 25, 2014
Study Record Updates
Last Update Posted (Estimate)
March 7, 2016
Last Update Submitted That Met QC Criteria
March 4, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- CCC-HFP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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