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AnemiaCHANGENCT02236468

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

A study testing Enhanced-Homestead Food Production Program (old), WASH/malaria behavior change and LNS distribution in people with Anemia and Growth Retardation, run by International Food Policy Research Institute at 1 site in Burkina Faso.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages Up to 12 monthsHealthy volunteers can take part
Conditions the study is for
Anemia, Growth Retardation
What is being tested?
Enhanced-Homestead Food Production Program (old), WASH/malaria behavior change and LNS distribution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,747 participants
Where
1 siteBurkina Faso
Study dates
Mar 2014to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 12 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • N/A

Trial locations and contacts

1 site in 1 country.

Burkina Faso1 site

  • Hellen Keller International

    Fada, Gourma

Other trials in Burkina Faso

About this study

Official title: Creating Homestead Agriculture for Nutrition and Gender Equity in Burkina Faso

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.

Read the 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)?
Being tested
Enhanced-Homestead Food Production Program (old), WASH/malaria behavior change, LNS distribution, Enhanced-Homestead Food Production Program (new)
Medical subject headings
Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhanced-Homestead Food Production Program (old)Other

    Participation in an enhanced-homestead food production program including home gardening and nutrition and health behavior change communication since 2010

  • WASH/malaria behavior changeBehavioural

    WASH/malaria behavior change communication

  • LNS distributionDietary supplement

    Distribution of Nutributter (Fanga Degue) for children

  • Enhanced-Homestead Food Production Program (new)Other

    Participation in an enhanced-homestead food production program including home gardening, poultry rearing and nutrition and health behavior change communication since 2014

Study groups in NCT02236468
Study groupRoleWhat they receive
new EHFPExperimentalGroup newly participating in an enhanced-homestead food production program including home gardening, poultry rearing and nutrition and health behavior change communication since 2014
Receives: Other: Enhanced-Homestead Food Production Program (new)
old EHFP+WASHExperimentalGroup 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
Receives: Other: Enhanced-Homestead Food Production Program (old); Behavioral: WASH/malaria behavior change
new EHFP+WASHOtherGroup 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
Receives: Behavioral: WASH/malaria behavior change; Other: Enhanced-Homestead Food Production Program (new)
old EHFP+WASH+LNS distributionOtherGroup 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
Receives: Other: Enhanced-Homestead Food Production Program (old); Behavioral: WASH/malaria behavior change; Dietary Supplement: LNS distribution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 (7)

  1. 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 .

    Measured: Baseline (2014) and after 24 months at Endline (2016)

  2. Food security (%)

    Measured with a questionnaire to calculate the HFIAS score. Unit: percentage of household

    Measured: Baseline (2014) and after 24 months at Endline (2016)

  3. 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).

    Measured: Baseline (2014) and after 24 months at Endline (2016)

  4. Women's empowerment (%)

    Measured by questionnaire, using a decision-making module and a domestic violence module. Percentage of women over a calculated score.

    Measured: Baseline (2014) and after 24 months at Endline (2016)

  5. Maternal health and nutrition/WASH/malaria-related knowledge (%)

    Using questionnaire on knowledge. Percentage of women giving adequate answer.

    Measured: Baseline (2014) and after 24 months at Endline (2016)

  6. IYCF/WASH/malaria practices (%)

    Using questionnaire on practices. Percentage of women with adequate practices.

    Measured: Baseline (2014) and after 24 months at Endline (2016)

  7. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,747 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02236468
Sponsor's protocol ID
CHANGE BF
Acronym
CHANGE
Status last verified
Sep 2016
First submitted
3 Sep 2014
Last updated
19 Sep 2016
Results posted
No
Data monitoring committee
No

Publications

  • Bliznashka L, Becquey E, Ruel MT, Pedehombga A, Nordhagen S, Olney DK. Adding Small Quantity Lipid-Based Nutrient Supplements to an Enhanced Homestead Food Production Program Improves Child Hemoglobin, Iron and Vitamin A Status in Rural Burkina Faso: A Cluster-Randomized Controlled Trial. J Nutr. 2026 Jun;156(6):101519. doi: 10.1016/j.tjnut.2026.101519. Epub 2026 Apr 1.

    PubMed 41932365

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced-Homestead Food Production Program (old), WASH/malaria behavior change and LNS distribution in people with Anemia and Growth Retardation, run by International Food Policy Research Institute at 1 site in Burkina Faso.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02236468, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2016.

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