MalnutritionL4HNCT04608656
Livestock for Health Project
A study testing Provision of livestock feeds and Nutrition counselling in people with Malnutrition, run by Washington State University at 1 site in Kenya.
Trial summary
Children 5 years and below, and pregnant/lactating women in pastoralist communities suffer a high burden of acute malnutrition. Improving the health and productivity of animals can reduce the risk malnutrition during the dry periods. Read more about this study
- Who is it for?
- Ages 6 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Provision of livestock feeds and Nutrition counselling
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,734 participants
- Where
- 1 siteKenya
- Study dates
- 4 Sep 2019to 30 Apr 2022
- 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 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Household inclusion criteria
- Only households meeting the following study criteria will be recruited:
- Presence of a mother (lactating or non-lactating) and child 3 years and below
- Ownership of livestock with 1-6 tropical livestock units
- Household consent to participate in the study o Including willingness to have 1-2 tropical livestock units (1-2 cattle or camel, 10-20 sheep/ goats) at household
Who cannot join
- Households excluded in the study will have the following criteria:
- Households that do not consent to participate in the study
- Households unwilling to adhere to the study protocol including feeding instructions and retaining the study animals at the household for milk access
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Livestock Programming for Nutritional Improvements in Pregnant, Lactating Mothers and Children Under Five Years of Age in Marsabit County, Kenya
Children 5 years and below, and pregnant/lactating women in pastoralist communities suffer a high burden of acute malnutrition. Improving the health and productivity of animals can reduce the risk malnutrition during the dry periods. The aim of this study is to assess how providing livestock with feeds during critical dry periods can improve household milk availability, consumption and risk of malnutrition in pregnant and lactating mothers, and children 5 years and below.
The study will be a cluster randomized control trial conducted in Marsabit County and will involve a total of 1800 households that own livestock and have children 5 years and below. The households will be divided into three groups and each group will have a total of 600 households. Group one, will receive livestock feed enough to maintain 2-3 milking animals during the critical dry period. The second group will receive similar livestock feed but will also receive education and counselling on human nutrition. The third group will be the control arm and will not receive any of the two interventions.
The study will aim to estimate how these interventions impact stunting and underweight in children and weight gain for pregnant women by collecting data on middle upper arm circumference, height, weight, and weight-gain during pregnancy every three months in a year. In addition, data on food consumption patterns such as number of meals taken, type/diversity of foods consumed including animal source foods, frequency of times and quantity of specific foods consumed) on at least 6-weekly basis will be collected. To further understand this problem the investigators will collect human illness data including on fever, diarrhoea, and respiratory syndromes among study participants during the regular visits. Socio-economic data including household demographics, incomes, expenditures, asset accumulation, gender roles, and workload and time allocation will be collected quarterly. Biological samples will be collected (venous blood and mother's milk) at recruitment, six months and 12 months. Screening for infections such as brucellosis, micronutrient and mycotoxin analysis will be conducted on the biological samples in order account for infections or conditions that could have an impact on nutritional status of study participants. The study will also assess which of the interventions provide value for money given that resources are scarce.
Read the detailed description
Background: In households heavily dependent on livestock, declining availability of forage is associated with decreased consumption of animal source foods such as milk and meat, and consequently decline in child nutritional status. Populations living in Kenya's Arid and Semi-Arid Lands(ASALs) are predominantly pastoral, heavily dependent on livestock and practice seasonal mobility to access livestock pasture and water. Livestock interventions that maintain or improve health and productivity of animals have been postulated as important for reducing the risk of malnutrition during critical drought periods.
Objectives: Here the investigators implement a cluster randomized control study trial to determine the effect of providing livestock feed, livestock feed and nutritional education and counselling during critical dry periods on household milk availability and consumption, and the risk of malnutrition in pregnant and lactating mothers, and children 5 years and below.
Methods: A total of 1800 households owning livestock and with children 3 years and below in Marsabit County will be enrolled into three equal groups (arms) of 600 households each. Each household and participant will be followed for 18 months. Households in Arm 1 will receive livestock feed enough to maintain 2-3 milking animals during the critical dry period. Arm 2 will receive similar livestock feed and human nutritional education and counselling. Arm 3 (control arm) will not have any of the two interventions. Primary outcome measures will be child anthropometric indicators (height-for-age, weight-for-age and middle upper arm circumference) and maternal anthropometric measures (middle upper arm circumference, height, weight, weight-gain during pregnancy) collected quarterly. Data on a 24-hour recall of diet (number of meals taken, type/diversity of foods consumed including animal source foods, frequency of times and quantity of specific foods consumed) will be collected every 6 weeks. To control for additional factors that would influence nutritional status, the investigators will collect human health syndromic data (fever, diarrhoea, respiratory syndromes) and livestock health data every six weeks and socio-economic data quarterly including household demographics, incomes, expenditures, asset accumulation, gender roles, workload and time allocation. To control for exposure to infections such as brucellosis in humans and animals and for micronutrient and mycotoxin analysis, biological samples (venous blood of mother and child), animal biological samples (blood and milk) and household drinking water will be collected at recruitment, 6 months and at 12 months. The study will test the cost-effectiveness of livestock interventions and nutritional counselling in prevention of malnutrition and its health consequences, compared to treatment of malnutrition. Cost data associated with each study arm will be tracked to provide estimates of resources required to scale up for implementation. Results from this study will form the basis for monitoring efficiency and effectiveness of interventions aimed at reducing seasonal spikes in levels of acute malnutrition in children under five years and pregnant and lactating women in pastoralist communities.
Study duration: Each study household and participant is followed for a period of 24 months from the time of enrolment into the study.
- Conditions
- Malnutrition
- Being tested
- Provision of livestock feeds, Nutrition counselling
- Keywords
- Children under five years, Pregnant and Lactating women, Livestock feeds, Nutrition counselling, Undernutrition, Pastoralism, Kenya
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provision of livestock feedsOther
Households will receive livestock feeds (ranch cubes) for the select lactating animals during the dry season
Nutrition counsellingOther
Households will receive livestock feeds (ranch cubes) for the select lactating animals and will also be enrolled in to a nutrition counselling programme
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm 1: Livestock feed only | Experimental | Households in villages assigned to intervention arm 1 will receive a pre-defined amount of feed to maintain two tropical livestock units for a total of 60 days during the dry season (when animals would be moved away in search of pastures). Receives: Other: Provision of livestock feeds |
| Intervention arm 2: 1. Provision of Livestock feeds, 2. Nutrition counselling | Experimental | Households recruited into intervention arm two will receive livestock feeds similar to intervention arm 1 and will be enrolled in a nutritional education and counselling program through Infant and Young Child Nutrition (IYCF) feeding program and household food utilization. The IYCF program through the Baby Friendly Community Initiative (BFCI) will include the promotion of exclusive breastfeeding in the first six months, continued breastfeeding up to the age of two years, adequate complementary feeding, hygiene promotion and the uptake of child health services including immunization, treatment of illness, moderate and severe acute malnutrition and micro-nutrient supplementation. Receives: Other: Provision of livestock feeds; Other: Nutrition counselling |
| Control arm | No intervention | The households recruited under this arm will receive none of the two study interventions. These households will receive identical assessment and data collection like other study households in the study. Their access to support through other interventions will be monitored. Households within the control arm will receive nutritional counselling and education given outside of the project. This is mainly at health facilities when mothers present for antenatal care or visit health facilities seeking healthcare. On some occasions in places where community health volunteers are present, nutritional counselling and education may be provided at the community level. The study instruments have been designed to collect information at the household level if such nutritional counselling and education has been provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Household milk yield (litres/week)
Compare the household milk yield in liters per week between the three study arms.
Average amount of milk produced per week by species (cattle, camels, goats and sheep)compare mean change in household average milk yield (litres/week) over study time by the intervention and control study arms.
Measured: 24 months
Milk consumption (amount and frequency) by children < 5 years and pregnant and lactating women
Compare the average daily milk intake for mothers and children participating in the study between the three study arms.
Measured: 24 months
Undernutrition (wasting, stunting and underweight)
Determine the levels and trends of undernutrition(wasting, stunting and underweight) among children < 5 years and pregnant and lactating women
Measured: 24 months
Cost-effectiveness ratio of (changes in total cost of interventions by arm )/(Changes in acute malnutrition (WHZ) by arm)
Determine if providing livestock feed, livestock feed and nutritional counselling is a cost-effective way of preventing acute malnutrition in children < 5 years and mothers.
A cost-effective analysis will be used to complete an economic assessment of the costs of malnutrition and treatment of malnutrition in the absence of livestock feed intervention, and livestock feed and nutritional counseling intervention. Costs will be quantified using intervention, treatment and economic data (including market prices and household sales) collected over the period of the study.
The cost-effectiveness analysis will be conducted in two stages;
- based on the changes in the acute malnutrition ($/WHZ) between the intervention arms and control arm, and
- using standardized measure encompassing both morbidity and mortality associated with malnutrition - cost per quality-adjusted life years (QALYs) gained or disability-adjusted life years (DALYs) averted .
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start4 Sep 2019
- Primary completion31 Dec 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies 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
- Factorial
- Model description
- The study households will be assigned one of three study arms: i) Intervention arm 1: Livestock feed only. Households in villages assigned to intervention arm 1 will receive a pre-defined amount of livestock feed to maintain two tropical livestock units for a total of 60 days during the dry season (when animals would be moved away in search of pastures). ii) Intervention arm 2: 1.Provision of Livestock feed, 2. Nutritional counselling Households recruited into intervention arm two will receive livestock feeds and will be enrolled in a nutritional education and counselling program. iii) Control arm The households recruited under this arm will receive none of the two study interventions. These households will receive identical assessment and data collection like other study households in the study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,734 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Agriculture Organization of the United Nations, UNICEF
- Responsible party
- Principal investigator, Thumbi Mwangi, Washington State University
- Investigators
- Thumbi Mwangi, PhD, Principal investigator, Washington State University, Paul G Allen School for Global Animal HealthJosphat M Muema, PhD(c), Study director, Washington State University - Global Health KenyaMutono Nyamai, PhD(c), Study director, Washington State University - Global Health KenyaGuy Palmer, PhD, Study chair, Washington State University, Paul G Allen School for Global Animal Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608656
- Sponsor's protocol ID
- KEMRI/SERU/CGHR/02-09/3755
- Acronym
- L4H
- Status last verified
- Dec 2023
- First submitted
- 7 Oct 2020
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A repository/database with all IPD that underlie results in all publications generated from the study will be developed
Publications
Thumbi SM, Muema J, Mutono N, Njuguna J, Jost C, Boyd E, Tewoldeberhan D, Mutua I, Gacharamu G, Wambua F, Allport R, Olesambu E, Osman AM, Souza D, Kimani I, Oyugi J, Bukania Z, Oboge H, Palmer GH, Yoder J. The Livestock for Health Study: A Field Trial on Livestock Interventions to Prevent Acute Malnutrition Among Women and Children in Pastoralist Communities in Northern Kenya. Food Nutr Bull. 2023 Dec;44(2_suppl):S119-S123. doi: 10.1177/03795721231195427.
PubMed 37850922
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Livestock Programming for Nutritional Improvements in Pregnant, Lactating Mothers and Children Under Five Years of Age in Marsabit County, Kenya
- ClinicalTrials.gov ID
- NCT04608656
- Acronym / sponsor ID
- L4H / KEMRI/SERU/CGHR/02-09/3755
- Conditions
- Malnutrition
- Keywords
- Children under five years, Pregnant and Lactating women, Livestock feeds, Nutrition counselling, Undernutrition, Pastoralism, Kenya
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,734 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- Food and Agriculture Organization of the United Nations, UNICEF
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 29 Oct 2020 (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.
Children 5 years and below, and pregnant/lactating women in pastoralist communities suffer a high burden of acute malnutrition. Improving the health and productivity of animals can reduce the risk malnutrition during the dry periods. The aim of this study is to assess how providing livestock with feeds during critical dry periods can improve household milk availability, consumption and risk of malnutrition in pregnant and lactating mothers, and children 5 years and below.
The study will be a cluster randomized control trial conducted in Marsabit County and will involve a total of 1800 households that own livestock and have children 5 years and below. The households will be divided into three groups and each group will have a total of 600 households. Group one, will receive livestock feed enough to maintain 2-3 milking animals during the critical dry period. The second group will receive similar livestock feed but will also receive education and counselling on human nutrition. The third group will be the control arm and will not receive any of the two interventions.
The study will aim to estimate how these interventions impact stunting and underweight in children and weight gain for pregnant women by collecting data on middle upper arm circumference, height, weight, and weight-gain during pregnancy every three months in a year. In addition, data on food consumption patterns such as number of meals taken, type/diversity of foods consumed including animal source foods, frequency of times and quantity of specific foods consumed) on at least 6-weekly basis will be collected. To further understand this problem the investigators will collect human illness data including on fever, diarrhoea, and respiratory syndromes among study participants during the regular visits. Socio-economic data including household demographics, incomes, expenditures, asset accumulation, gender roles, and workload and time allocation will be collected quarterly. Biological samples will be collected (venous blood and mother's milk) at recruitment, six months and 12 months. Screening for infections such as brucellosis, micronutrient and mycotoxin analysis will be conducted on the biological samples in order account for infections or conditions that could have an impact on nutritional status of study participants. The study will also assess which of the interventions provide value for money given that resources are scarce.
Detailed description
Background: In households heavily dependent on livestock, declining availability of forage is associated with decreased consumption of animal source foods such as milk and meat, and consequently decline in child nutritional status. Populations living in Kenya's Arid and Semi-Arid Lands(ASALs) are predominantly pastoral, heavily dependent on livestock and practice seasonal mobility to access livestock pasture and water. Livestock interventions that maintain or improve health and productivity of animals have been postulated as important for reducing the risk of malnutrition during critical drought periods.
Objectives: Here the investigators implement a cluster randomized control study trial to determine the effect of providing livestock feed, livestock feed and nutritional education and counselling during critical dry periods on household milk availability and consumption, and the risk of malnutrition in pregnant and lactating mothers, and children 5 years and below.
Methods: A total of 1800 households owning livestock and with children 3 years and below in Marsabit County will be enrolled into three equal groups (arms) of 600 households each. Each household and participant will be followed for 18 months. Households in Arm 1 will receive livestock feed enough to maintain 2-3 milking animals during the critical dry period. Arm 2 will receive similar livestock feed and human nutritional education and counselling. Arm 3 (control arm) will not have any of the two interventions. Primary outcome measures will be child anthropometric indicators (height-for-age, weight-for-age and middle upper arm circumference) and maternal anthropometric measures (middle upper arm circumference, height, weight, weight-gain during pregnancy) collected quarterly. Data on a 24-hour recall of diet (number of meals taken, type/diversity of foods consumed including animal source foods, frequency of times and quantity of specific foods consumed) will be collected every 6 weeks. To control for additional factors that would influence nutritional status, the investigators will collect human health syndromic data (fever, diarrhoea, respiratory syndromes) and livestock health data every six weeks and socio-economic data quarterly including household demographics, incomes, expenditures, asset accumulation, gender roles, workload and time allocation. To control for exposure to infections such as brucellosis in humans and animals and for micronutrient and mycotoxin analysis, biological samples (venous blood of mother and child), animal biological samples (blood and milk) and household drinking water will be collected at recruitment, 6 months and at 12 months. The study will test the cost-effectiveness of livestock interventions and nutritional counselling in prevention of malnutrition and its health consequences, compared to treatment of malnutrition. Cost data associated with each study arm will be tracked to provide estimates of resources required to scale up for implementation. Results from this study will form the basis for monitoring efficiency and effectiveness of interventions aimed at reducing seasonal spikes in levels of acute malnutrition in children under five years and pregnant and lactating women in pastoralist communities.
Study duration: Each study household and participant is followed for a period of 24 months from the time of enrolment into the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The study households will be assigned one of three study arms: i) Intervention arm 1: Livestock feed only. Households in villages assigned to intervention arm 1 will receive a pre-defined amount of livestock feed to maintain two tropical livestock units for a total of 60 days during the dry season (when animals would be moved away in search of pastures). ii) Intervention arm 2: 1.Provision of Livestock feed, 2. Nutritional counselling Households recruited into intervention arm two will receive livestock feeds and will be enrolled in a nutritional education and counselling program. iii) Control arm The households recruited under this arm will receive none of the two study interventions. These households will receive identical assessment and data collection like other study households in the study.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm 1: Livestock feed only | Experimental | Other: Provision of livestock feedsHouseholds in villages assigned to intervention arm 1 will receive a pre-defined amount of feed to maintain two tropical livestock units for a total of 60 days during the dry season (when animals would be moved away in search of pastures). |
| Intervention arm 2: 1. Provision of Livestock feeds, 2. Nutrition counselling | Experimental | Other: Provision of livestock feeds, Other: Nutrition counsellingHouseholds recruited into intervention arm two will receive livestock feeds similar to intervention arm 1 and will be enrolled in a nutritional education and counselling program through Infant and Young Child Nutrition (IYCF) feeding program and household food utilization. The IYCF program through the Baby Friendly Community Initiative (BFCI) will include the promotion of exclusive breastfeeding in the first six months, continued breastfeeding up to the age of two years, adequate complementary feeding, hygiene promotion and the uptake of child health services including immunization, treatment of illness, moderate and severe acute malnutrition and micro-nutrient supplementation. |
| Control arm | No intervention | –The households recruited under this arm will receive none of the two study interventions. These households will receive identical assessment and data collection like other study households in the study. Their access to support through other interventions will be monitored. Households within the control arm will receive nutritional counselling and education given outside of the project. This is mainly at health facilities when mothers present for antenatal care or visit health facilities seeking healthcare. On some occasions in places where community health volunteers are present, nutritional counselling and education may be provided at the community level. The study instruments have been designed to collect information at the household level if such nutritional counselling and education has been provided. |
Who may qualify
- Ages
- 6 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Household inclusion criteria
- Presence of a mother (lactating or non-lactating) and child 3 years and below
- Ownership of livestock with 1-6 tropical livestock units
- Household consent to participate in the study o Including willingness to have 1-2 tropical livestock units (1-2 cattle or camel, 10-20 sheep/ goats) at household
Key exclusion criteria (3 listed)
- Households excluded in the study will have the following criteria:
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 |
|---|---|---|
| Provision of livestock feedsHouseholds will receive livestock feeds (ranch cubes) for the select lactating animals during the dry season | Other | Intervention arm 1: Livestock feed only, Intervention arm 2: 1. Provision of Livestock feeds, 2. Nutrition counselling |
| Nutrition counsellingHouseholds will receive livestock feeds (ranch cubes) for the select lactating animals and will also be enrolled in to a nutrition counselling programme | Other | Intervention arm 2: 1. Provision of Livestock feeds, 2. Nutrition counselling |
Primary outcome
Household milk yield (litres/week)
Time frame: 24 months
Compare the household milk yield in liters per week between the three study arms. Average amount of milk produced per week by species (cattle, camels, goats and sheep)compare mean change in household average milk yield (litres/week) over study time by the intervention and control study arms.
Milk consumption (amount and frequency) by children < 5 years and pregnant and lactating women
Time frame: 24 months
Compare the average daily milk intake for mothers and children participating in the study between the three study arms.
Undernutrition (wasting, stunting and underweight)
Time frame: 24 months
Determine the levels and trends of undernutrition(wasting, stunting and underweight) among children < 5 years and pregnant and lactating women
Cost-effectiveness ratio of (changes in total cost of interventions by arm )/(Changes in acute malnutrition (WHZ) by arm)
Time frame: 24 months
Determine if providing livestock feed, livestock feed and nutritional counselling is a cost-effective way of preventing acute malnutrition in children < 5 years and mothers. A cost-effective analysis will be used to complete an economic assessment of the costs of malnutrition and treatment of malnutrition in the absence of livestock feed intervention, and livestock feed and nutritional counseling intervention. Costs will be quantified using intervention, treatment and economic data (including market prices and household sales) collected over the period of the study. The cost-effectiveness analysis will be conducted in two stages; 1. based on the changes in the acute malnutrition ($/WHZ) between the intervention arms and control arm, and 2. using standardized measure encompassing both morbidity and mortality associated with malnutrition - cost per quality-adjusted life years (QALYs) gained or disability-adjusted life years (DALYs) averted .
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 12 Dec 2023.
- Derived from this study: PubMed 37850922Thumbi SM, Muema J, Mutono N, Njuguna J, Jost C, Boyd E, Tewoldeberhan D, Mutua I, Gacharamu G, Wambua F, Allport R, Olesambu E, Osman AM, Souza D, Kimani I, Oyugi J, Bukania Z, Oboge H, Palmer GH, Yoder J. The Livestock for Health Study: A Field Trial on Livestock Interventions to Prevent Acute Malnutrition Among Women and Children in Pastoralist Communities in Northern Kenya. Food Nutr Bull. 2023 Dec;44(2_suppl):S119-S123. doi: 10.1177/03795721231195427.
- Individual participant dataSharing planned: Yes. A repository/database with all IPD that underlie results in all publications generated from the study will be developed
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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.
Thumbi Mwangi, PhD principal investigator
Washington State University, Paul G Allen School for Global Animal Health
Josphat M Muema, PhD(c) study director
Washington State University - Global Health Kenya
Mutono Nyamai, PhD(c) study director
Washington State University - Global Health Kenya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provision of livestock feeds and Nutrition counselling in people with Malnutrition, run by Washington State University at 1 site in Kenya.
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 3 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 12 Dec 2023. 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 Kenya. 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?
Household milk yield (litres/week) (time frame: 24 months). The study lists 4 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 NCT04608656, 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 12 Dec 2023.