Creating Homestead Agriculture for Nutrition and Gender Equity (CHANGE) in Burkina Faso

Anemia Clinical Trial

— CHANGE  

Official title:

Creating Homestead Agriculture for Nutrition and Gender Equity in Burkina Faso

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236468
• Other study ID #: CHANGE BF
• Status: Completed
• Phase: N/A
• First received: September 3, 2014
• Last updated: September 16, 2016
• Start date: March 2014
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: International Food Policy Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Burkina Faso: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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)?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2747
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

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

Related Conditions & MeSH terms

• Anemia
• Growth Retardation

Intervention

Other:
• Enhanced-Homestead Food Production Program (old)
Participation in an enhanced-homestead food production program including home gardening and nutrition and health behavior change communication since 2010

Behavioral:
• WASH/malaria behavior change
WASH/malaria behavior change communication

Dietary Supplement:
• LNS distribution
Distribution of Nutributter (Fanga Degue) for children

Other:
• Enhanced-Homestead Food Production Program (new)
Participation in an enhanced-homestead food production program including home gardening, poultry rearing and nutrition and health behavior change communication since 2014

Locations

Country	Name	City	State
Burkina Faso	Hellen Keller International	Fada	Gourma

Sponsors (3)

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

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin (g/dl)	Changes in hemoglobin (g/dl) and in prevalence of anemia (<11g/dl) will be measured over the course of the two year program period.	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.	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 24 months at Endline (2016)	No
Secondary	Food security (%)	Measured with a questionnaire to calculate the HFIAS score. Unit: percentage of household	Baseline (2014) and after 24 months at Endline (2016)	No
Secondary	Biochemical markers	Change in plasmatic concentration of iron biomarkers (tranferrin receptors and ferritin; TfR in mg/L and F in µg/L), in concentration of vitamine A biomarkers (retinolbindingprotein; RBP in µmol/L) and inflammatory proteins (C-reactiveprotein and alpha-1 acidglycoprotein; CRP in mg/L and AGP in g/L).	Baseline (2014) and after 24 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 24 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 24 months at Endline (2016)	No
Secondary	IYCF/WASH/malaria practices (%)	Using questionnaire on practices. Percentage of women with adequate practices.	Baseline (2014) and after 24 months at Endline (2016)	No
Secondary	Growth (Z-score and %)	Change in heigh-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 (WAS<-2) and wasting (WHZ<-2) over the course of the two year program period.	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.	No