Clinical trial NCT02236468: Creating Homestead Agriculture for Nutrition and Gender Equity (CHANGE) in Burkina Faso
Official title: Creating Homestead Agriculture for Nutrition and Gender Equity in Burkina Faso
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
First posted: 2014-09-10
Enrollment: 2747
Sex: ALL
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 the long-term impact of the Enhanced Homestead Food Production Program implemented by HKI on household food security and nutritional status, as well as the impact on including additional interventions (BCC on WASH and malaria prevention, distribution of preventive lipid-based nutrient supplements (LNS)) to children aged 6-24 months old, in addition to the standard E-HFP model.

Detailed description: Over the past twenty years, Helen Keller International (HKI) has implemented its Homestead Food Production (HFP) program to increase household production of micronutrient-rich foods and improve the quality of diets among vulnerable households across Asia and, more recently, Africa. As part of the program, village model farms -which support diversified, year-round production of micronutrient-rich crops, and improved breeds of poultry and small animals-are established to demonstrate gardening and small animal-raising techniques to program participants. Program participants in turn are established to demonstrate gardening and small animal-raising techniques to program participants. Program participants in turn are provided with small inputs such as seeds, seedlings, and small tools to establish home gardens using techniques they learn at the village model farms. In addition, the program uses a behavior change communication (BCC) strategy to increase participant's health and nutrition-related knowledge and practices.

In 2010, HKI introduced an enhanced-HFP (E-HFP) model in the Gourma province of Burkina Faso with support from the USAID. The project used a randomized cluster design to assess the impact of HKI's package of interventions on 1,200 beneficiary and 800 control children aged 3-12 months at baseline. Given the encouraging results of IFPRI's first evaluation of that project, HKI is working to continue to improve and evaluate its E-HFP program in Burkina Faso. Based on the recommendations from the initial evaluation in Burkina Faso, this research aims to assess both the long-term impact of the E-HFP program as well as the impact of including additional interventions, using the E-HFP platform to deliver these interventions. The primary research questions that will be addresses will be:

* What is the relative impact of a long-term E-HFP program compared to a short-term E-HFP program on household food security and child nutritional status?
* What is the impact of including additional messages and the promotion of practices related to water, sanitation, hygiene, and malaria prevention (including bednet utilization) in the BCC strategy, in addition to the standard E-HFP model?
* What is the impact of distributing preventive lipid-based nutrient supplements (LNS) to children between the ages of 6-24 months in addition to participation in the E-HFP program + additional messages and the promotion of practices related to water, sanitation, hygiene, and malaria prevention (including bednet utilization)?

Eligibility criteria: Inclusion Criteria:

* Mother of child between the ages of 0 and 12 months and her child

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Hemoglobin (g/dl)
timeFrame: Measurements will be made for children between the ages of 0 and 12 months of age at baseline and 2 years later, at endline, when the children are between the ages of 24 and 36 months.
Secondary outcomes:
measure: Dietary diversity (%)
timeFrame: Baseline (2014) and after 24 months at Endline (2016)
measure: Food security (%)
timeFrame: Baseline (2014) and after 24 months at Endline (2016)
measure: Biochemical markers
timeFrame: Baseline (2014) and after 24 months at Endline (2016)
measure: Women's empowerment (%)
timeFrame: Baseline (2014) and after 24 months at Endline (2016)
measure: Maternal health and nutrition/WASH/malaria-related knowledge (%)
timeFrame: Baseline (2014) and after 24 months at Endline (2016)
measure: IYCF/WASH/malaria practices (%)
timeFrame: Baseline (2014) and after 24 months at Endline (2016)
measure: Growth (Z-score and %)
timeFrame: Measurements will be made for children between the ages of 0 and 12 months of age at baseline and 2 years later, at endline, when the children are between the ages of 24 and 36 months.
Other outcomes:
Locations:
city: Fada
country: Burkina Faso
facility: Hellen Keller International
state: Gourma
Study officials:
affiliation: International Food Policy Research Institute
name: Deanna Olney, PhD
role: PRINCIPAL_INVESTIGATOR
References: