Poverty, Low Income, Food Insecurity, UndernutritionNCT03336021

Impact Evaluation of Agribusiness Support and Nutrition Services Projects in Upper Egypt

A study testing FAS program in people with Poverty, Low Income, Food Insecurity, Undernutrition, run by International Food Policy Research Institute.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

This project seeks to evaluate the impact of two USAID-funded projects that are implemented in rural Upper Egypt. The first project is the Feed the Future Egypt, Food-Security and Agribusiness Support (FAS) project; the second project is the Improving Maternal, Child Health, and Nutrition Services (IMCHN) project. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Poverty, Low Income, Food Insecurity, Undernutrition
What is being tested?: FAS program
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: 1 Nov 2017to Apr 2019
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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

None listed.

Who cannot join

Farmers with more than 10 feddans per household
Farmers with no interest in horticulture production

About this study

The specific study objectives are (1) to estimate the impact of FAS interventions on project outcome indicators-especially on household income (measured by total household expenditure), household food security, and maternal and child nutrition-among farm households; (2) to estimate the effects of IMCHN interventions on maternal and child health and nutrition knowledge among community health workers (CHWs) and among farm households; and (3) to analytically explore potential synergistic effects of FAS and IMCHN interventions on maternal and child nutrition among farm households being exposed to both projects.

Conditions: Poverty, Low Income, Food Insecurity, Undernutrition
Being tested: FAS program
Medical subject headings: Malnutrition

What participants receive

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

FAS programOther
Intervention households are farmers who will receive a forward contract through the FAS program; in addition, they may receive other support such as extension, seeds, etc.

Study groups in NCT03336021
Study group	Role	What they receive
Intervention	Experimental	FAS program Receives: Other: FAS program
Comparison	No intervention	Comparison group

What is being measured

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

Household income
household income measured through household total (and food) expenditure
Measured: After 5 to 6 months of exposure (april 2018)
Household food security
Household Food Insecurity Access Scale (HFIAS)
Measured: After 5 to 6 months of exposure (april 2018)

Secondary outcomes (13)

Household income
household income measured through household total (and food) expenditure
Measured: After 17 to 18 months of exposure (april 2019)
Household food security
Household Food Insecurity Access Scale (HFIAS)
Measured: After 17 to 18 months of exposure (april 2019)
Farm production and output: yields
Harvested yields
Measured: After 5 to 6 months of exposure (april 2018) and after 17 to 18 months of exposure (april 2019)
Farm production and output: prices
Selling prices
Measured: After 5 to 6 months of exposure (april 2018) and after 17 to 18 months of exposure (april 2019)
Farm production and output: home consumption
Home consumption
Measured: After 5 to 6 months of exposure (april 2018) and after 17 to 18 months of exposure (april 2019)
Women's Empowerment in Agriculture
Women's level of empowerment in agriculture-related decision making
Measured: After 5 to 6 months of exposure (april 2018) and after 17 to 18 months of exposure (april 2019)
Household dietary diversity
Household Dietary Diversity Score (HDDS)
Measured: After 5 to 6 months of exposure (april 2018) and after 17 to 18 months of exposure (april 2019)
Women's dietary diversity
Minimum Dietary Diversity - Women (MDD-W) score
Measured: After 5 to 6 months of exposure (april 2018) and after 17 to 18 months of exposure (april 2019)
Infant and Young Child Feeding practices
IYCF practices as measured using the WHO IYCF guidelines
Measured: After 5 to 6 months of exposure (april 2018) and after 17 to 18 months of exposure (april 2019)
Child anthropometry: weight
weight of children 0-23.9 months (baseline), 24-59.9 months (baseline)
Measured: After 5 to 6 months of exposure (april 2018) and after 17 to 18 months of exposure (april 2019)
Child anthropometry: height
height and weight of children 0-23.9 months (baseline), 24-59.9 months (baseline)
Measured: After 5 to 6 months of exposure (april 2018) and after 17 to 18 months of exposure (april 2019)
Adult anthropometry: mother
weight of mother / female caretaker
Measured: After 5 to 6 months of exposure (april 2018) and after 17 to 18 months of exposure (april 2019)
Adult anthropometry: father
weight of father / household head
Measured: After 5 to 6 months of exposure (april 2018) and after 17 to 18 months of exposure (april 2019)

Timeline

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

1 Nov 2017Apr 2019

First posted8 Nov 2017
Study start1 Nov 2017
Primary completionApr 2019 (estimated)
Study completionApr 2019 (estimated)

Why it stopped: Intervention not implemented as planned

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Poverty, Low Income, Food Insecurity, UndernutritionStudies 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: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03336021
Sponsor's protocol ID: 602114.002.001
Status last verified: Nov 2017
First submitted: 26 Oct 2017
Last updated: 11 May 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact Evaluation of Agribusiness Support and Nutrition Services Projects in Upper Egypt
ClinicalTrials.gov ID: NCT03336021
Acronym / sponsor ID: 602114.002.001
Conditions: Poverty, Low Income, Food Insecurity, Undernutrition
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Intervention not implemented as planned
Enrolment: 0 participants (actual)
Lead sponsor: International Food Policy Research InstituteUniversity, hospital or other
Study start: 1 Nov 2017 (actual)
Primary completion: Apr 2019 (estimated)
Study completion: Apr 2019 (estimated)
First posted: 8 Nov 2017 (actual)
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.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Other: FAS programFAS program
Comparison	No intervention	–Comparison group

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (2 listed)

Farmers with more than 10 feddans per household
Farmers with no interest in horticulture production

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
FAS programIntervention households are farmers who will receive a forward contract through the FAS program; in addition, they may receive other support such as extension, seeds, etc.	Other	Intervention

Primary outcome

Household income
Time frame: After 5 to 6 months of exposure (april 2018)
household income measured through household total (and food) expenditure
Household food security
Time frame: After 5 to 6 months of exposure (april 2018)
Household Food Insecurity Access Scale (HFIAS)

13 secondary outcomes

Household income
Time frame: After 17 to 18 months of exposure (april 2019)
Household food security
Time frame: After 17 to 18 months of exposure (april 2019)
Farm production and output: yields
Time frame: After 5 to 6 months of exposure (april 2018) and after 17 to 18 months of exposure (april 2019)
Farm production and output: prices
Time frame: After 5 to 6 months of exposure (april 2018) and after 17 to 18 months of exposure (april 2019)
Farm production and output: home consumption
Time frame: After 5 to 6 months of exposure (april 2018) and after 17 to 18 months of exposure (april 2019)
Women's Empowerment in Agriculture
Time frame: After 5 to 6 months of exposure (april 2018) and after 17 to 18 months of exposure (april 2019)
Household dietary diversity
Time frame: After 5 to 6 months of exposure (april 2018) and after 17 to 18 months of exposure (april 2019)
Women's dietary diversity
Time frame: After 5 to 6 months of exposure (april 2018) and after 17 to 18 months of exposure (april 2019)
Infant and Young Child Feeding practices
Time frame: After 5 to 6 months of exposure (april 2018) and after 17 to 18 months of exposure (april 2019)
Child anthropometry: weight
Time frame: After 5 to 6 months of exposure (april 2018) and after 17 to 18 months of exposure (april 2019)
Child anthropometry: height
Time frame: After 5 to 6 months of exposure (april 2018) and after 17 to 18 months of exposure (april 2019)
Adult anthropometry: mother
Time frame: After 5 to 6 months of exposure (april 2018) and after 17 to 18 months of exposure (april 2019)
Adult anthropometry: father
Time frame: After 5 to 6 months of exposure (april 2018) and after 17 to 18 months of exposure (april 2019)

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
Individual participant dataSharing planned: Undecided

Related trials for Poverty, Low Income, Food Insecurity, Undernutrition

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Recruiting
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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.

Clemens Breisinger, PhD study director

IFPRI

Jose Luis Figueroa, PhD principal investigator

IFPRI

Questions about this trial

What is this clinical trial studying?

A study testing FAS program in people with Poverty, Low Income, Food Insecurity, Undernutrition, run by International Food Policy Research Institute.

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 0 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: withdrawn, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Household income (time frame: After 5 to 6 months of exposure (april 2018)). The study lists 2 primary outcomes in all. 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 NCT03336021.

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 11 May 2018.