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Trial record 1 of 1 for:    NCT02236468
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Creating Homestead Agriculture for Nutrition and Gender Equity (CHANGE) in Burkina Faso (CHANGE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02236468
First Posted: September 10, 2014
Last Update Posted: September 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Helen Keller International
Foreign Affairs, Trade and Development, Canada
Information provided by (Responsible Party):
International Food Policy Research Institute
  Purpose
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.

Condition Intervention
Anemia Growth Retardation Other: Enhanced-Homestead Food Production Program (old) Behavioral: WASH/malaria behavior change Dietary Supplement: LNS distribution Other: Enhanced-Homestead Food Production Program (new)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Creating Homestead Agriculture for Nutrition and Gender Equity in Burkina Faso

Further study details as provided by International Food Policy Research Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 .

  • 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

  • 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).

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 2747
Study Start Date: March 2014
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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
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
Behavioral: WASH/malaria behavior change
WASH/malaria behavior change communication
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
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
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236468


Locations
Burkina Faso
Hellen Keller International
Fada, Gourma, Burkina Faso
Sponsors and Collaborators
International Food Policy Research Institute
Helen Keller International
Foreign Affairs, Trade and Development, Canada
Investigators
Principal Investigator: Deanna Olney, PhD International Food Policy Research Institute
  More Information

Responsible Party: International Food Policy Research Institute
ClinicalTrials.gov Identifier: NCT02236468     History of Changes
Other Study ID Numbers: CHANGE BF
First Submitted: September 3, 2014
First Posted: September 10, 2014
Last Update Posted: September 19, 2016
Last Verified: September 2016