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Livestock for Health Project (L4H)

Primary Purpose

Malnutrition

Status
Unknown status
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Provision of livestock feeds
Nutrition counselling
Sponsored by
Washington State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition focused on measuring Children under five years, Pregnant and Lactating women, Livestock feeds, Nutrition counselling, Undernutrition, Pastoralism, Kenya

Eligibility Criteria

6 Months - 60 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Washington State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Intervention arm 1: Livestock feed only

Intervention arm 2: 1. Provision of Livestock feeds, 2. Nutrition counselling

Control arm

Arm Description

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).

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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
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 .

Secondary Outcome Measures

Full Information

First Posted
October 7, 2020
Last Updated
October 23, 2020
Sponsor
Washington State University
Collaborators
Food and Agriculture Organization of the United Nations, UNICEF
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1. Study Identification

Unique Protocol Identification Number
NCT04608656
Brief Title
Livestock for Health Project
Acronym
L4H
Official Title
Livestock Programming for Nutritional Improvements in Pregnant, Lactating Mothers and Children Under Five Years of Age in Marsabit County, Kenya
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 4, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington State University
Collaborators
Food and Agriculture Organization of the United Nations, UNICEF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Children under five years, Pregnant and Lactating women, Livestock feeds, Nutrition counselling, Undernutrition, Pastoralism, Kenya

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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
ParticipantInvestigator
Masking Description
Data collection enumerators will not be aware which intervention arm the households belong to.
Allocation
Randomized
Enrollment
1800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm 1: Livestock feed only
Arm Type
Experimental
Arm Description
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).
Arm Title
Intervention arm 2: 1. Provision of Livestock feeds, 2. Nutrition counselling
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Provision of livestock feeds
Intervention Description
Households will receive livestock feeds (ranch cubes) for the select lactating animals during the dry season
Intervention Type
Other
Intervention Name(s)
Nutrition counselling
Intervention Description
Households will receive livestock feeds (ranch cubes) for the select lactating animals and will also be enrolled in to a nutrition counselling programme
Primary Outcome Measure Information:
Title
Household milk yield (litres/week)
Description
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.
Time Frame
24 months
Title
Milk consumption (amount and frequency) by children < 5 years and pregnant and lactating women
Description
Compare the average daily milk intake for mothers and children participating in the study between the three study arms.
Time Frame
24 months
Title
Undernutrition (wasting, stunting and underweight)
Description
Determine the levels and trends of undernutrition(wasting, stunting and underweight) among children < 5 years and pregnant and lactating women
Time Frame
24 months
Title
Cost-effectiveness ratio of (changes in total cost of interventions by arm )/(Changes in acute malnutrition (WHZ) by arm)
Description
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 .
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thumbi Mwangi, PhD
Organizational Affiliation
Washington State University, Paul G Allen School for Global Animal Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Josphat M Muema, PhD(c)
Organizational Affiliation
Washington State University - Global Health Kenya
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mutono Nyamai, PhD(c)
Organizational Affiliation
Washington State University - Global Health Kenya
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Guy Palmer, PhD
Organizational Affiliation
Washington State University, Paul G Allen School for Global Animal Health
Official's Role
Study Chair
Facility Information:
Facility Name
Washington State University
City
Nairobi
Country
Kenya

12. IPD Sharing Statement

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Livestock for Health Project

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