- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02259166
Enhanced Homestead Food Production Plus+ Program in the Lake Zone, Tanzania
Impact of the Evaluation of the Enhanced Homestead Food Production Program in Sengerema, and Ukerewe in the Lake Zone,Tanzania
Study Overview
Detailed Description
Since 1988, Helen Keller International's (HKI) flagship Homestead Food Production (HFP) program in Asia has helped communities establish technically-improved local food production systems by creating gardens yielding micronutrient-rich fruits and vegetables over expanded growing seasons, complemented by the improved rearing of poultry and livestock.
In 2010, HKI introduced an enhanced-HFP (E-HFP) model in Burkina Faso and included a strengthened nutrition education component; the Essential Nutrition Actions (ENA) framework. This E-HFP program was evaluated by IFPRI and yielded some encouraging results. With regards to nutritional outcomes, however, the primary finding was that, while the E-HFP program improved hemoglobin concentration-an indicator of iron status-the evaluation failed to note a significant impact of the program on improving children's growth. The primary explanation for the absence of a measurable improvement in children's growth was the lack of complementary health interventions that aim to specifically reduce children's disease burden, which, along with the lack of adequate food and care, is an underlying cause of undernutriton (UNICEF 1990).
Building on lessons learned from the Burkina Faso E-HFP program and a 2011 Tanzania HFP program, a new model, the Enhanced Homestead Food Production Plus (E-HFP+), was developed for Tanzania to improve the nutritional status of infants and young children. The new model strengthens the Behavior Change Communication (BCC) on malaria prevention, WASH, and gender components and enhances links with the health sector. The model will also test two new concepts:
- to assess if the E-HFP+ program has the potential to maintain adequate levels of hemoglobin concentrations by increasing iron-rich food consumption and malaria prevention good practices.
- to assess the effectiveness on anemia of using an existing agriculture-based platform to promote uptake and utilization of MNP.
The model involves both a set of production and nutrition interventions targeted to mothers and the provision of a curative treatment for moderate to severe anemia (Micronutrient Powder).
The main objective of the impact evaluation of the E-HFP+ program is therefore to assess whether the program:
- Maintains reduced anemia levels among pre-school aged children after a blanket provision of Micronutrient Powder (MNP)
- Improves child growth (measured by HAZ and WHZ)
- Improves infant and young child feeding (IYCF) practices and maternal knowledge on health and nutrition
- Is an appropriate delivery platform to enhance uptake and utilization of MNP supplementation in children
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Mwanza, Tanzania
- National Institute for Medical Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- women living in the study area
- having one child aged 6-12 months of age
Exclusion Criteria:
- children with severe anemia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EHFP+
Group receiving the intervention EHFP+, in addition to MNPs distribution for 2 months and malaria diagnosis and treatment for children enrolled, at baseline and after 12 months
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Enhanced-homestead food production program including home gardening and poultry rearing + WASH interventions + SBCC around the essential nutrition actions and WASH/malaria prevention with a gender component.
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No Intervention: Control
MNPs distribution for 2 months and malaria diagnosis and treatment for children enrolled, at baseline and after 12 months
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anemia (g/dl and %)
Time Frame: Measurements will be made for children aged 6 to 11 months at baseline and up to 3 months, 6 months, 12 months and 18 months (at endline), when the children are between the ages of 24 and 30 months
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Change in prevalence of anemia and hemoglobin concentration will be measured over the course of the program period.(at
baseline, during follow-up after 3, 6 and 12 months and after 18 months at endline)
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Measurements will be made for children aged 6 to 11 months at baseline and up to 3 months, 6 months, 12 months and 18 months (at endline), when the children are between the ages of 24 and 30 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Growth (Z-score and %)
Time Frame: Measurements will be made for children between the ages of 6 and 11 months of age at baseline and 18 months later, at endline, when the children are between the ages of 24 and 30 months
|
Change in height-for-age Z-scores, weight-for-age Z-scores and weight-for-height Z-scores will be measured as well as the change in the prevalence of stunting (HAZ<-2), underweight (WAZ<-2) and wasting (WHZ<-2) over the course of the program period
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Measurements will be made for children between the ages of 6 and 11 months of age at baseline and 18 months later, at endline, when the children are between the ages of 24 and 30 months
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Biochemical markers
Time Frame: Baseline (June 2014), Follow-up1 (up to 3 months) and after 18 months at Endline
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Change in plasmatic concentration of iron biomarkers (transferring receptors and ferritin; TfR and F), in concentration of vitamin A biomarkers (retinolbindingprotein; RBP) and inflammatory proteins (C-reactiveprotein and alpha-1 acidglycoprotein; CRP and AGP)
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Baseline (June 2014), Follow-up1 (up to 3 months) and after 18 months at Endline
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Dietary diversity (%)
Time Frame: Baseline (2014) and after 18 months at Endline
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Measured with a questionnaire using a qualitative 24h recall.
Unit: Number of food group consumed and percentage of children having consumed 4 groups (upon 7) the previous day
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Baseline (2014) and after 18 months at Endline
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Food security (%)
Time Frame: Baseline (2014) and after 18 months at Endline (2016)
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Measured with a questionnaire to calculate the HFIAS score.
Unit: percentage of household
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Baseline (2014) and after 18 months at Endline (2016)
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Women's empowerment (%)
Time Frame: Baseline (2014) and after 18 months at Endline (2016)
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Measured by questionnaire, using a decision-making module and a domestic violence module.
Percentage of women over a calculated score.
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Baseline (2014) and after 18 months at Endline (2016)
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Maternal health and nutrition/WASH/malaria-related knowledge (%)
Time Frame: Baseline (2014) and after 18 months at Endline (2016)
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Using questionnaire on knowledge.
Percentage of women giving adequate answer.
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Baseline (2014) and after 18 months at Endline (2016)
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IYCF/WASH/malaria practices (%)
Time Frame: Baseline (2014) and after 18 months at Endline (2016)
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Using questionnaire on practices.
Percentage of women with adequate practices.
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Baseline (2014) and after 18 months at Endline (2016)
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Rahul Rawat, PhD, International Food Policy Research Institute
- Principal Investigator: Erin Smith, Helen Keller International
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EHFP+ TZ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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