- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02236468
Creating Homestead Agriculture for Nutrition and Gender Equity (CHANGE) in Burkina Faso (CHANGE)
Creating Homestead Agriculture for Nutrition and Gender Equity in Burkina Faso
Study Overview
Status
Conditions
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)?
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gourma
-
Fada, Gourma, Burkina Faso
- Hellen Keller International
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Mother of child between the ages of 0 and 12 months and her child
Exclusion Criteria:
- N/A
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: new EHFP
Group newly participating in an enhanced-homestead food production program including home gardening, poultry rearing and nutrition and health behavior change communication since 2014
|
Participation in an enhanced-homestead food production program including home gardening, poultry rearing and nutrition and health behavior change communication since 2014
|
|
Experimental: old EHFP+WASH
Group participating in an enhanced-homestead food production program including home gardening and nutrition and health behavior change communication since 2010 + WASH/malaria behavior change communication since 2014
|
Participation in an enhanced-homestead food production program including home gardening and nutrition and health behavior change communication since 2010
WASH/malaria behavior change communication
|
|
Other: new EHFP+WASH
Group newly participating in an enhanced-homestead food production program including home gardening, poultry rearing and nutrition and health behavior change communication since 2014 + WASH/malaria behavior change communication since 2014
|
Participation in an enhanced-homestead food production program including home gardening, poultry rearing and nutrition and health behavior change communication since 2014
WASH/malaria behavior change communication
|
|
Other: old EHFP+WASH+LNS distribution
Group participating in an enhanced-homestead food production program including home gardening and nutrition and health behavior change communication since 2010 + WASH/malaria behavior change communication and distribution of LNS since 2014
|
Participation in an enhanced-homestead food production program including home gardening and nutrition and health behavior change communication since 2010
WASH/malaria behavior change communication
Distribution of Nutributter (Fanga Degue) for children
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hemoglobin (g/dl)
Time Frame: 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.
|
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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dietary diversity (%)
Time Frame: Baseline (2014) and after 24 months at Endline (2016)
|
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)
|
|
Food security (%)
Time Frame: Baseline (2014) and after 24 months at Endline (2016)
|
Measured with a questionnaire to calculate the HFIAS score.
Unit: percentage of household
|
Baseline (2014) and after 24 months at Endline (2016)
|
|
Biochemical markers
Time Frame: Baseline (2014) and after 24 months at Endline (2016)
|
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)
|
|
Women's empowerment (%)
Time Frame: Baseline (2014) and after 24 months at Endline (2016)
|
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)
|
|
Maternal health and nutrition/WASH/malaria-related knowledge (%)
Time Frame: Baseline (2014) and after 24 months at Endline (2016)
|
Using questionnaire on knowledge.
Percentage of women giving adequate answer.
|
Baseline (2014) and after 24 months at Endline (2016)
|
|
IYCF/WASH/malaria practices (%)
Time Frame: Baseline (2014) and after 24 months at Endline (2016)
|
Using questionnaire on practices.
Percentage of women with adequate practices.
|
Baseline (2014) and after 24 months at Endline (2016)
|
|
Growth (Z-score and %)
Time Frame: 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.
|
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.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Deanna Olney, PhD, International Food Policy Research Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CHANGE BF
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