Enhanced Homestead Food Production Plus+ Program in the Lake Zone, Tanzania

Anemia Clinical Trial

Official title:

Impact of the Evaluation of the Enhanced Homestead Food Production Program in Sengerema, and Ukerewe in the Lake Zone,Tanzania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02259166
• Other study ID #: EHFP+ TZ
• 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

• Anemia
• Growth Retardation

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