AnemiaNCT02259166
Enhanced Homestead Food Production Plus+ Program in the Lake Zone, Tanzania
A study testing EHFP+ in people with Anemia and Growth Retardation, run by International Food Policy Research Institute at 1 site in Tanzania.
Trial summary
The purpose of this study is to assess if the Enhanced Homestead Food Production Plus (EHFP+) Program implemented by HKI in Mwanza, Tanzania, enhances uptake of Micronutrient Powder (MNP) supplementation in children, helps maintaining reduced anemia levels among children after a blanket provision of MNP, and has an… Read more about this study
- Who is it for?
- Ages 6 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Anemia, Growth Retardation
- What is being tested?
- EHFP+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,325 participants
- Where
- 1 siteTanzania
- Study dates
- Jun 2014to Mar 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 6 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- women living in the study area
- having one child aged 6-12 months of age
Who cannot join
- children with severe anemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Evaluation of the Enhanced Homestead Food Production Program in Sengerema, and Ukerewe in the Lake Zone,Tanzania
The purpose of this study is to assess if the Enhanced Homestead Food Production Plus (EHFP+) Program implemented by HKI in Mwanza, Tanzania, enhances uptake of Micronutrient Powder (MNP) supplementation in children, helps maintaining reduced anemia levels among children after a blanket provision of MNP, and has an impact on child growth, infant and young child feeding (IYCF) practices, maternal knowledge related to health, nutrition, WASH and malaria prevention, food security and women's empowerment.
Read the detailed description
Since 1988, Helen Keller International's (HKI) flagship Homestead Food Production (HFP) program in Asia has helped communities establish technically-improved local food production systems by creating gardens yielding micronutrient-rich fruits and vegetables over expanded growing seasons, complemented by the improved rearing of poultry and livestock.
In 2010, HKI introduced an enhanced-HFP (E-HFP) model in Burkina Faso and included a strengthened nutrition education component; the Essential Nutrition Actions (ENA) framework. This E-HFP program was evaluated by IFPRI and yielded some encouraging results. With regards to nutritional outcomes, however, the primary finding was that, while the E-HFP program improved hemoglobin concentration-an indicator of iron status-the evaluation failed to note a significant impact of the program on improving children's growth. The primary explanation for the absence of a measurable improvement in children's growth was the lack of complementary health interventions that aim to specifically reduce children's disease burden, which, along with the lack of adequate food and care, is an underlying cause of undernutriton (UNICEF 1990).
Building on lessons learned from the Burkina Faso E-HFP program and a 2011 Tanzania HFP program, a new model, the Enhanced Homestead Food Production Plus (E-HFP+), was developed for Tanzania to improve the nutritional status of infants and young children. The new model strengthens the Behavior Change Communication (BCC) on malaria prevention, WASH, and gender components and enhances links with the health sector. The model will also test two new concepts:
- to assess if the E-HFP+ program has the potential to maintain adequate levels of hemoglobin concentrations by increasing iron-rich food consumption and malaria prevention good practices.
- to assess the effectiveness on anemia of using an existing agriculture-based platform to promote uptake and utilization of MNP.
The model involves both a set of production and nutrition interventions targeted to mothers and the provision of a curative treatment for moderate to severe anemia (Micronutrient Powder).
The main objective of the impact evaluation of the E-HFP+ program is therefore to assess whether the program:
- Maintains reduced anemia levels among pre-school aged children after a blanket provision of Micronutrient Powder (MNP)
- Improves child growth (measured by HAZ and WHZ)
- Improves infant and young child feeding (IYCF) practices and maternal knowledge on health and nutrition
- Is an appropriate delivery platform to enhance uptake and utilization of MNP supplementation in children
- Conditions
- Anemia, Growth Retardation
- Being tested
- EHFP+
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EHFP+Other
Enhanced-homestead food production program including home gardening and poultry rearing + WASH interventions + SBCC around the essential nutrition actions and WASH/malaria prevention with a gender component.
| Study group | Role | What they receive |
|---|---|---|
| EHFP+ | Experimental | Group receiving the intervention EHFP+, in addition to MNPs distribution for 2 months and malaria diagnosis and treatment for children enrolled, at baseline and after 12 months Receives: Other: EHFP+ |
| Control | No intervention | MNPs distribution for 2 months and malaria diagnosis and treatment for children enrolled, at baseline and after 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anemia (g/dl and %)
Change in prevalence of anemia and hemoglobin concentration will be measured over the course of the program period.(at baseline, during follow-up after 3, 6 and 12 months and after 18 months at endline)
Measured: Measurements will be made for children aged 6 to 11 months at baseline and up to 3 months, 6 months, 12 months and 18 months (at endline), when the children are between the ages of 24 and 30 months
Secondary outcomes (7)
Growth (Z-score and %)
Change in height-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 (WAZ<-2) and wasting (WHZ<-2) over the course of the program period
Measured: Measurements will be made for children between the ages of 6 and 11 months of age at baseline and 18 months later, at endline, when the children are between the ages of 24 and 30 months
Biochemical markers
Change in plasmatic concentration of iron biomarkers (transferring receptors and ferritin; TfR and F), in concentration of vitamin A biomarkers (retinolbindingprotein; RBP) and inflammatory proteins (C-reactiveprotein and alpha-1 acidglycoprotein; CRP and AGP)
Measured: Baseline (June 2014), Follow-up1 (up to 3 months) and after 18 months at Endline
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 18 months at Endline
Food security (%)
Measured with a questionnaire to calculate the HFIAS score. Unit: percentage of household
Measured: Baseline (2014) and after 18 months at Endline (2016)
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 18 months at Endline (2016)
Maternal health and nutrition/WASH/malaria-related knowledge (%)
Using questionnaire on knowledge. Percentage of women giving adequate answer.
Measured: Baseline (2014) and after 18 months at Endline (2016)
IYCF/WASH/malaria practices (%)
Using questionnaire on practices. Percentage of women with adequate practices.
Measured: Baseline (2014) and after 18 months at Endline (2016)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 2,325 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Helen Keller International, Foreign Affairs, Trade and Development, Canada, National Institute for Medical Research, Tanzania
- Responsible party
- Sponsor
- Investigators
- Rahul Rawat, PhD, Principal investigator, International Food Policy Research InstituteErin Smith, Principal investigator, Helen Keller International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259166
- Sponsor's protocol ID
- EHFP+ TZ
- Status last verified
- Sep 2015
- First submitted
- 5 Sep 2014
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Evaluation of the Enhanced Homestead Food Production Program in Sengerema, and Ukerewe in the Lake Zone,Tanzania
- ClinicalTrials.gov ID
- NCT02259166
- Acronym / sponsor ID
- EHFP+ TZ
- Conditions
- Anemia, Growth Retardation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,325 participants (actual)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Collaborators
- Helen Keller International, Foreign Affairs, Trade and Development, Canada, National Institute for Medical Research, Tanzania
- Study start
- Jun 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 8 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess if the Enhanced Homestead Food Production Plus (EHFP+) Program implemented by HKI in Mwanza, Tanzania, enhances uptake of Micronutrient Powder (MNP) supplementation in children, helps maintaining reduced anemia levels among children after a blanket provision of MNP, and has an impact on child growth, infant and young child feeding (IYCF) practices, maternal knowledge related to health, nutrition, WASH and malaria prevention, food security and women's empowerment.
Detailed description
Since 1988, Helen Keller International's (HKI) flagship Homestead Food Production (HFP) program in Asia has helped communities establish technically-improved local food production systems by creating gardens yielding micronutrient-rich fruits and vegetables over expanded growing seasons, complemented by the improved rearing of poultry and livestock.
In 2010, HKI introduced an enhanced-HFP (E-HFP) model in Burkina Faso and included a strengthened nutrition education component; the Essential Nutrition Actions (ENA) framework. This E-HFP program was evaluated by IFPRI and yielded some encouraging results. With regards to nutritional outcomes, however, the primary finding was that, while the E-HFP program improved hemoglobin concentration-an indicator of iron status-the evaluation failed to note a significant impact of the program on improving children's growth. The primary explanation for the absence of a measurable improvement in children's growth was the lack of complementary health interventions that aim to specifically reduce children's disease burden, which, along with the lack of adequate food and care, is an underlying cause of undernutriton (UNICEF 1990).
Building on lessons learned from the Burkina Faso E-HFP program and a 2011 Tanzania HFP program, a new model, the Enhanced Homestead Food Production Plus (E-HFP+), was developed for Tanzania to improve the nutritional status of infants and young children. The new model strengthens the Behavior Change Communication (BCC) on malaria prevention, WASH, and gender components and enhances links with the health sector. The model will also test two new concepts:
- to assess if the E-HFP+ program has the potential to maintain adequate levels of hemoglobin concentrations by increasing iron-rich food consumption and malaria prevention good practices.
- to assess the effectiveness on anemia of using an existing agriculture-based platform to promote uptake and utilization of MNP.
The model involves both a set of production and nutrition interventions targeted to mothers and the provision of a curative treatment for moderate to severe anemia (Micronutrient Powder).
The main objective of the impact evaluation of the E-HFP+ program is therefore to assess whether the program:
- Maintains reduced anemia levels among pre-school aged children after a blanket provision of Micronutrient Powder (MNP)
- Improves child growth (measured by HAZ and WHZ)
- Improves infant and young child feeding (IYCF) practices and maternal knowledge on health and nutrition
- Is an appropriate delivery platform to enhance uptake and utilization of MNP supplementation in children
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EHFP+ | Experimental | Other: EHFP+Group receiving the intervention EHFP+, in addition to MNPs distribution for 2 months and malaria diagnosis and treatment for children enrolled, at baseline and after 12 months |
| Control | No intervention | –MNPs distribution for 2 months and malaria diagnosis and treatment for children enrolled, at baseline and after 12 months |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- women living in the study area
- having one child aged 6-12 months of age
Key exclusion criteria (1 listed)
- children with severe anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EHFP+Enhanced-homestead food production program including home gardening and poultry rearing + WASH interventions + SBCC around the essential nutrition actions and WASH/malaria prevention with a gender component. | Other | EHFP+ |
Primary outcome
Anemia (g/dl and %)
Time frame: Measurements will be made for children aged 6 to 11 months at baseline and up to 3 months, 6 months, 12 months and 18 months (at endline), when the children are between the ages of 24 and 30 months
Change in prevalence of anemia and hemoglobin concentration will be measured over the course of the program period.(at baseline, during follow-up after 3, 6 and 12 months and after 18 months at endline)
7 secondary outcomes
Growth (Z-score and %)
Time frame: Measurements will be made for children between the ages of 6 and 11 months of age at baseline and 18 months later, at endline, when the children are between the ages of 24 and 30 months
Biochemical markers
Time frame: Baseline (June 2014), Follow-up1 (up to 3 months) and after 18 months at Endline
Dietary diversity (%)
Time frame: Baseline (2014) and after 18 months at Endline
Food security (%)
Time frame: Baseline (2014) and after 18 months at Endline (2016)
Women's empowerment (%)
Time frame: Baseline (2014) and after 18 months at Endline (2016)
Maternal health and nutrition/WASH/malaria-related knowledge (%)
Time frame: Baseline (2014) and after 18 months at Endline (2016)
IYCF/WASH/malaria practices (%)
Time frame: Baseline (2014) and after 18 months at Endline (2016)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rahul Rawat, PhD principal investigator
International Food Policy Research Institute
Erin Smith principal investigator
Helen Keller International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EHFP+ in people with Anemia and Growth Retardation, run by International Food Policy Research Institute at 1 site in Tanzania.
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 2 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 Tanzania. 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?
Anemia (g/dl and %) (time frame: Measurements will be made for children aged 6 to 11 months at baseline and up to 3 months, 6 months, 12 months and 18 months (at endline), when the children are between the ages of 24 and 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.