MalnutritionNCT02808117
Microfinance Institutions as a Platform for Global Health
An observational study of Malnutrition and Anemia, run by Columbia University at 1 site in United States.
Trial summary
This study will analyze data from a program run by an microfinance institution (MFI) in Haiti from 2011-2012 where the MFI delivered health goods to some of the villages where it operates. Read more about this study
- Who is it for?
- Ages 6 to 54 months
- Conditions the study is for
- Malnutrition, Anemia
- What is being tested?
- MNP
- How many people
- 526 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Nov 2016
- Phase
- Observational
- 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 54 months
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 6-54 months who lived in a household where the head of household was an microfinance client.
Who may be able to join
- Lives in a household where the head of household was an microfinance client.
Who cannot join
- Severely anemic (Hgb < 70 g/L)
- Severely malnourished (Mid Upper Arm Circumference < 110 mm)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microfinance Institutions as a Platform for Global Health Delivery: Evidence From a Pilot Program
This study will analyze data from a program run by an microfinance institution (MFI) in Haiti from 2011-2012 where the MFI delivered health goods to some of the villages where it operates. By comparing health indicators among children who were in villages targeted by the program initially to children who were in villages that were not targeted by the program until later, the investigators hope to understand if the MFI successfully delivered the intervention and offer a practical platform for delivery of basic health goods.
Read the detailed description
Two-thirds of child deaths could be prevented with increased coverage of existing health products and services; however, effectively delivering health products and services to rural populations in low-income countries remains a practical challenge. This study investigates whether microfinance institutions (MFIs), having invested in community-based infrastructure to deliver financial services to 200 million rural poor households globally, offer a practical platform for delivery of basic health goods.
The investigators intend to analyze data from a pilot program implemented by an MFI in Haiti during 2011-2012 that distributed an evidence-based health good, micronutrient powders (MNPs), to 526 children in 34 villages where the MFI operates. Micronutrient deficiency is estimated to be responsible for over 1 million deaths of children under five per year. MNPs are one form of micronutrient supplementation proven to effectively combat micronutrient deficiency.
Published cost estimates indicate that leveraging existing supply chains could cut the total cost of mass MNP delivery by 25%. Given MFIs reach 200 million households globally, MFI-based delivery of health goods may be a promising route to improving health outcomes efficiently.
- Conditions
- Malnutrition, Anemia
- Being tested
- MNP
- Keywords
- microfinance institution, MFI
- Medical subject headings
- Malnutrition, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MNPDietary supplement
Also called Micronutrient powders, Sprinkles
Program that delivered MNP and implemented by an MFI in Haiti during 2011-2012.
One form of micronutrient supplementation proven to effectively combat micronutrient deficiency.
| Study group | Role | What they receive |
|---|---|---|
| Targeted initially | Children who were in the Haiti villages and targeted by the MFI program with MNP delivery initially. Receives: Dietary Supplement: MNP | |
| Targeted later | Children who were in the Haiti villages and not targeted by the MFI program with MNP delivery until later. Receives: Dietary Supplement: MNP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood hemoglobin concentration
Measured: Baseline, 3 months
Secondary outcomes (1)
Prevalence of diagnosis of anemia
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startMay 2015
- Primary completionAug 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 526 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Isaac Baum, Columbia University
- Investigators
- Aaron I Baum, PhD, Study director, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808117
- Sponsor's protocol ID
- AAAP7004
- Status last verified
- Nov 2016
- First submitted
- 17 Jun 2016
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microfinance Institutions as a Platform for Global Health Delivery: Evidence From a Pilot Program
- ClinicalTrials.gov ID
- NCT02808117
- Acronym / sponsor ID
- AAAP7004
- Conditions
- Malnutrition, Anemia
- Keywords
- microfinance institution, MFI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 526 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 21 Jun 2016 (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.
This study will analyze data from a program run by an microfinance institution (MFI) in Haiti from 2011-2012 where the MFI delivered health goods to some of the villages where it operates. By comparing health indicators among children who were in villages targeted by the program initially to children who were in villages that were not targeted by the program until later, the investigators hope to understand if the MFI successfully delivered the intervention and offer a practical platform for delivery of basic health goods.
Detailed description
Two-thirds of child deaths could be prevented with increased coverage of existing health products and services; however, effectively delivering health products and services to rural populations in low-income countries remains a practical challenge. This study investigates whether microfinance institutions (MFIs), having invested in community-based infrastructure to deliver financial services to 200 million rural poor households globally, offer a practical platform for delivery of basic health goods.
The investigators intend to analyze data from a pilot program implemented by an MFI in Haiti during 2011-2012 that distributed an evidence-based health good, micronutrient powders (MNPs), to 526 children in 34 villages where the MFI operates. Micronutrient deficiency is estimated to be responsible for over 1 million deaths of children under five per year. MNPs are one form of micronutrient supplementation proven to effectively combat micronutrient deficiency.
Published cost estimates indicate that leveraging existing supply chains could cut the total cost of mass MNP delivery by 25%. Given MFIs reach 200 million households globally, MFI-based delivery of health goods may be a promising route to improving health outcomes efficiently.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted initially | – | Dietary Supplement: MNPChildren who were in the Haiti villages and targeted by the MFI program with MNP delivery initially. |
| Targeted later | – | Dietary Supplement: MNPChildren who were in the Haiti villages and not targeted by the MFI program with MNP delivery until later. |
Who may qualify
- Ages
- 6 to 54 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 6-54 months who lived in a household where the head of household was an microfinance client.
Key inclusion criteria (1 listed)
- Lives in a household where the head of household was an microfinance client.
Key exclusion criteria (2 listed)
- Severely anemic (Hgb < 70 g/L)
- Severely malnourished (Mid Upper Arm Circumference < 110 mm)
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 |
|---|---|---|
| MNPAlso: Micronutrient powders, SprinklesProgram that delivered MNP and implemented by an MFI in Haiti during 2011-2012. One form of micronutrient supplementation proven to effectively combat micronutrient deficiency. | Dietary supplement | Targeted initially, Targeted later |
Primary outcome
Change in blood hemoglobin concentration
Time frame: Baseline, 3 months
1 secondary outcome
Prevalence of diagnosis of anemia
Time frame: 3 months
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 30 Nov 2016.
- Individual participant dataSharing planned: Undecided
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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.
Aaron I Baum, PhD study director
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and Anemia, run by Columbia University at 1 site in United States.
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 2 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 30 Nov 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 United States. 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?
Change in blood hemoglobin concentration (time frame: Baseline, 3 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 30 Nov 2016.