Malnutrition, ChildNCT05890378
Integrated Livestock Management for Nutrition in Children Under Five Years of Age in Chad
An observational study of Malnutrition, Child, run by Tufts University.
Trial summary
The main objective of this study is to determine the effectiveness of a livestock management intervention, with considerations for animal food security, water contamination from animals, and nutrition counseling, in reducing the risk of acute malnutrition among children under the age of 5 years in Kanem and Bahr El… Read more about this study
- Who is it for?
- Ages 6 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Child
- What is being tested?
- Testing water
- How many people
- 15,000 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Feb 2026
- 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 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Although the final target for many nutrition messages will be women with young children, their ability to carry out promoted practices depends on the influence and control of a range of actors. Likewise, both men and women in households with livestock make decisions that affect resources provided to milking animals and access to milk - and these individuals are affected by a range of other actors in the community.
Who may be able to join
- Communities selected for the research have to be near a seasonal river
- Households (within those communities) have to have at least one child between the ages of 6 and 59 months.
- Households (within those communities) have to have at least one Tropical Livestock Unit (TLU) of livestock. One TLU is equivalent to either one cow, one camel, 10 goats or 10 sheep.
- Within those households, we will interview the female caretaker
- Anthropometry data will be collected from children 6-59 months and the female caretaker
Who cannot join
- lack of children under 5 years of age and/or a required livestock unit
Trial locations and contacts
No sites are listed yet.
Anna Ronell, PhD contact
About this study
Official title: Integrated Livestock Management for Nutrition in Children Under Five Years of Age
The main objective of this study is to determine the effectiveness of a livestock management intervention, with considerations for animal food security, water contamination from animals, and nutrition counseling, in reducing the risk of acute malnutrition among children under the age of 5 years in Kanem and Bahr El Ghazel (BeG) in Chad.
Read the detailed description
The main objective of this study is to determine the effectiveness of a livestock management intervention, with considerations for animal food security, water contamination from animals, and nutrition counseling, in reducing the risk of acute malnutrition among children under the age of 5 years in Kanem and Bahr El Ghazel (BeG) in Chad. To get at this objective we will be comparing across four study arms: 1) fodder provision, 2) water management/treatment, 3) combination of fodder and water management/treatment and 4) a control. All four arms will receive nutrition counseling, animal vaccination, and animal deworming.
Specifically, the study aims to answer the following research questions in the implementation research:
- Does provision of animal feed and nutrition counseling lead to a reduction in child acute malnutrition of children under five?
- Does messaging pulling on existing local strategies to improve protected water access for animals and humans, provision of a chlorine dispenser, and nutrition counseling lead to a reduction in child acute malnutrition of children under five?
- Does provision of animal feed, nutrition counseling, in combination with messaging pulling on existing local strategies to improve protected water access for animals and humans lead to a reduction in child acute malnutrition of children under five?
In preparation for the implementation of the intervention, we will conduct formative research to better contextualize the interventions and data collection. The formative research will seek to answer the following research questions.
- What is the water quality of and practices around different types of unimproved water sources?
- Which water sources are used by households, and what is their distance from the community?
- What zoonotic pathogens are present in animal and human fecal matter, and in milk?
- What is the highest acceptable (using the flavor rating assessment method - Table 5) concentration of chlorine to provide safe water for users?
The study will be done in a phased approach:
- Year 1: formative research
- Year 2: impact evaluation
- Year 3: sustainability study
- Conditions
- Malnutrition, Child
- Being tested
- Testing water
- Keywords
- malnutrition
- Medical subject headings
- Child Nutrition Disorders, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing waterOther
Using existing secondary data available on the research communities as well as qualitative inquiry, we will purposefully select 40 water sources for the water analysis across from the communities selected for the implementation research (up to 30 communities with a maximum of 5 water sources per community). The selection of water sources will be stratified by type of water sourceand near the route for long-term animal migration. For each water source, we will aim to have a water sample collected at all water sources twice a day (morning and later afternoon) once a week for four weeks, varying the day of the week. Thus, we will collect a total of 320 water samples in the course of four weeks at the end of the dry season before the rains start.
| Study group | Role | What they receive |
|---|---|---|
| Cohort by Water Source | Using existing secondary data available on the research communities as well as qualitative inquiry, we will purposefully select 40 water sources for the water analysis across from the communities selected for the implementation research (up to 30 communities with a maximum of 5 water sources per community). The selection of water sources will be stratified by type of water sourceand near the route for long-term animal migration. For each water source, we will aim to have a water sample collected at all water sources twice a day (morning and later afternoon) once a week for four weeks, varying the day of the week. Thus, we will collect a total of 320 water samples in the course of four weeks at the end of the dry season before the rains start. Receives: Other: Testing water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Water Quality
Water quality: total coliform and E. coli
Measured: 2023-2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study startJul 2023 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition, ChildStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Agriculture Organization of the United Nations
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890378
- Sponsor's protocol ID
- Marshak-FAO-Chad
- Status last verified
- Jun 2023
- First submitted
- 25 May 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Livestock Management for Nutrition in Children Under Five Years of Age
- ClinicalTrials.gov ID
- NCT05890378
- Acronym / sponsor ID
- Marshak-FAO-Chad
- Conditions
- Malnutrition, Child
- Keywords
- malnutrition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Food and Agriculture Organization of the United Nations
- Study start
- Jul 2023 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 6 Jun 2023 (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.
The main objective of this study is to determine the effectiveness of a livestock management intervention, with considerations for animal food security, water contamination from animals, and nutrition counseling, in reducing the risk of acute malnutrition among children under the age of 5 years in Kanem and Bahr El Ghazel (BeG) in Chad.
Detailed description
The main objective of this study is to determine the effectiveness of a livestock management intervention, with considerations for animal food security, water contamination from animals, and nutrition counseling, in reducing the risk of acute malnutrition among children under the age of 5 years in Kanem and Bahr El Ghazel (BeG) in Chad. To get at this objective we will be comparing across four study arms: 1) fodder provision, 2) water management/treatment, 3) combination of fodder and water management/treatment and 4) a control. All four arms will receive nutrition counseling, animal vaccination, and animal deworming.
Specifically, the study aims to answer the following research questions in the implementation research:
- Does provision of animal feed and nutrition counseling lead to a reduction in child acute malnutrition of children under five?
- Does messaging pulling on existing local strategies to improve protected water access for animals and humans, provision of a chlorine dispenser, and nutrition counseling lead to a reduction in child acute malnutrition of children under five?
- Does provision of animal feed, nutrition counseling, in combination with messaging pulling on existing local strategies to improve protected water access for animals and humans lead to a reduction in child acute malnutrition of children under five?
In preparation for the implementation of the intervention, we will conduct formative research to better contextualize the interventions and data collection. The formative research will seek to answer the following research questions.
- What is the water quality of and practices around different types of unimproved water sources?
- Which water sources are used by households, and what is their distance from the community?
- What zoonotic pathogens are present in animal and human fecal matter, and in milk?
- What is the highest acceptable (using the flavor rating assessment method - Table 5) concentration of chlorine to provide safe water for users?
The study will be done in a phased approach:
- Year 1: formative research
- Year 2: impact evaluation
- Year 3: sustainability study
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort by Water Source | – | Other: Testing waterUsing existing secondary data available on the research communities as well as qualitative inquiry, we will purposefully select 40 water sources for the water analysis across from the communities selected for the implementation research (up to 30 communities with a maximum of 5 water sources per community). The selection of water sources will be stratified by type of water sourceand near the route for long-term animal migration. For each water source, we will aim to have a water sample collected at all water sources twice a day (morning and later afternoon) once a week for four weeks, varying the day of the week. Thus, we will collect a total of 320 water samples in the course of four weeks at the end of the dry season before the rains start. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Although the final target for many nutrition messages will be women with young children, their ability to carry out promoted practices depends on the influence and control of a range of actors. Likewise, both men and women in households with livestock make decisions that affect resources provided to milking animals and access to milk - and these individuals are affected by a range of other actors in the community.
Key inclusion criteria (5 listed)
- Communities selected for the research have to be near a seasonal river
- Households (within those communities) have to have at least one child between the ages of 6 and 59 months.
- Households (within those communities) have to have at least one Tropical Livestock Unit (TLU) of livestock. One TLU is equivalent to either one cow, one camel, 10 goats or 10 sheep.
- Within those households, we will interview the female caretaker
- Anthropometry data will be collected from children 6-59 months and the female caretaker
Key exclusion criteria (1 listed)
- lack of children under 5 years of age and/or a required livestock unit
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 |
|---|---|---|
| Testing waterUsing existing secondary data available on the research communities as well as qualitative inquiry, we will purposefully select 40 water sources for the water analysis across from the communities selected for the implementation research (up to 30 communities with a maximum of 5 water sources per community). The selection of water sources will be stratified by type of water sourceand near the route for long-term animal migration. For each water source, we will aim to have a water sample collected at all water sources twice a day (morning and later afternoon) once a week for four weeks, varying the day of the week. Thus, we will collect a total of 320 water samples in the course of four weeks at the end of the dry season before the rains start. | Other | Cohort by Water Source |
Primary outcome
Water Quality
Time frame: 2023-2026
Water quality: total coliform and E. coli
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- 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.
Anna Ronell, PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, Child, run by Tufts University.
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 5 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: status not confirmed, as of the sponsor's last update on 7 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anastasia Marshak, PhD ((617) 627-3423, anastasia.marshak@tufts.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Water Quality (time frame: 2023-2026). 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 7 Jun 2023.