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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02259166
Other study ID # EHFP+ TZ
Secondary ID
Status Completed
Phase N/A
First received September 5, 2014
Last updated September 16, 2016
Start date June 2014
Est. completion date March 2016

Study information

Verified date September 2015
Source International Food Policy Research Institute
Contact n/a
Is FDA regulated No
Health authority Tanzania: Ministry of Health
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 2325
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Months to 12 Months
Eligibility Inclusion Criteria:

- women living in the study area

- having one child aged 6-12 months of age

Exclusion Criteria:

- children with severe anemia

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
EHFP+
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.

Locations

Country Name City State
Tanzania National Institute for Medical Research Mwanza

Sponsors (4)

Lead Sponsor Collaborator
International Food Policy Research Institute Foreign Affairs, Trade and Development, Canada, Helen Keller International, National Institute for Medical Research, Tanzania

Country where clinical trial is conducted

Tanzania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anemia (g/dl and %) 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) 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 No
Secondary Growth (Z-score and %) 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 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 No
Secondary Biochemical markers 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) Baseline (June 2014), Follow-up1 (up to 3 months) and after 18 months at Endline No
Secondary Dietary diversity (%) 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 Baseline (2014) and after 18 months at Endline No
Secondary Food security (%) Measured with a questionnaire to calculate the HFIAS score. Unit: percentage of household Baseline (2014) and after 18 months at Endline (2016) No
Secondary Women's empowerment (%) Measured by questionnaire, using a decision-making module and a domestic violence module. Percentage of women over a calculated score. Baseline (2014) and after 18 months at Endline (2016) No
Secondary Maternal health and nutrition/WASH/malaria-related knowledge (%) Using questionnaire on knowledge. Percentage of women giving adequate answer. Baseline (2014) and after 18 months at Endline (2016) No
Secondary IYCF/WASH/malaria practices (%) Using questionnaire on practices. Percentage of women with adequate practices. Baseline (2014) and after 18 months at Endline (2016) No
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