Livestock for Health Project

Malnutrition Clinical Trial

— L4H  

Official title:

Livestock Programming for Nutritional Improvements in Pregnant, Lactating Mothers and Children Under Five Years of Age in Marsabit County, Kenya

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04608656
• Other study ID #: KEMRI/SERU/CGHR/02-09/3755
• Status: Completed
• Phase: N/A
• Start date: September 4, 2019
• Est. completion date: April 30, 2022

Study information

• Verified date: December 2023
• Source: Washington State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1734
• Est. completion date: April 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 60 Months

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

Other:
• Provision of livestock feeds
Households will receive livestock feeds (ranch cubes) for the select lactating animals during the dry season
• Nutrition counselling
Households will receive livestock feeds (ranch cubes) for the select lactating animals and will also be enrolled in to a nutrition counselling programme

Locations

Country	Name	City	State
Kenya	Washington State University	Nairobi

Sponsors (3)

Lead Sponsor	Collaborator
Washington State University	Food and Agriculture Organization of the United Nations, UNICEF

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months
Primary	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.	24 months
Primary	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	24 months
Primary	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 .	24 months