Clinical trial NCT02259166: Enhanced Homestead Food Production Plus+ Program in the Lake Zone, Tanzania
Official title: Impact of the Evaluation of the Enhanced Homestead Food Production Program in Sengerema, and Ukerewe in the Lake Zone,Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Growth Retardation
Lead sponsor: International Food Policy Research Institute
Sponsor class: OTHER
Collaborators: name: Helen Keller International
name: Foreign Affairs, Trade and Development, Canada
name: National Institute for Medical Research, Tanzania
First posted: 2014-10-08
Enrollment: 2325
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess if the Enhanced Homestead Food Production Plus (EHFP+) Program implemented by HKI in Mwanza, Tanzania, enhances uptake of Micronutrient Powder (MNP) supplementation in children, helps maintaining reduced anemia levels among children after a blanket provision of MNP, and has an impact on child growth, infant and young child feeding (IYCF) practices, maternal knowledge related to health, nutrition, WASH and malaria prevention, food security and women's empowerment.

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:

1. 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.
2. 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

Eligibility criteria: Inclusion Criteria:

* women living in the study area
* having one child aged 6-12 months of age

Exclusion Criteria:

* children with severe anemia

Primary outcomes:
measure: Anemia (g/dl and %)
timeFrame: 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 outcomes:
measure: Growth (Z-score and %)
timeFrame: 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
measure: Biochemical markers
timeFrame: Baseline (June 2014), Follow-up1 (up to 3 months) and after 18 months at Endline
measure: Dietary diversity (%)
timeFrame: Baseline (2014) and after 18 months at Endline
measure: Food security (%)
timeFrame: Baseline (2014) and after 18 months at Endline (2016)
measure: Women's empowerment (%)
timeFrame: Baseline (2014) and after 18 months at Endline (2016)
measure: Maternal health and nutrition/WASH/malaria-related knowledge (%)
timeFrame: Baseline (2014) and after 18 months at Endline (2016)
measure: IYCF/WASH/malaria practices (%)
timeFrame: Baseline (2014) and after 18 months at Endline (2016)
Other outcomes:
Locations:
city: Mwanza
country: Tanzania
facility: National Institute for Medical Research
Study officials:
affiliation: International Food Policy Research Institute
name: Rahul Rawat, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helen Keller International
name: Erin Smith
role: PRINCIPAL_INVESTIGATOR
References: