Livestock for Health Project

NCT04608656 | Completed

• 1 other identifier: KEMRI/SERU/CGHR/02-09/3755
• Study Type: interventional
• Target: 1,734
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition

Keywords

Children under five years; Pregnant and Lactating women; Livestock feeds; Nutrition counselling; Undernutrition; Pastoralism; Kenya

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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; 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 .

  24 months

Study Arms (3)

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).

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.

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.

Interventions

Provision of livestock feeds OTHER

Households will receive livestock feeds (ranch cubes) for the select lactating animals during the dry season

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

Nutrition counselling OTHER

Households will receive livestock feeds (ranch cubes) for the select lactating animals and will also be enrolled in to a nutrition counselling programme

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

Eligibility Criteria

• Age: 6 Months - 60 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington State University: lead
• Food and Agriculture Organization of the United Nations: collaborator
• UNICEF: collaborator

Study Sites (1)

Washington State University

Nairobi, Kenya

Location

Related Publications (1)

• 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.

  PMID: 37850922 DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Thumbi Mwangi, PhD

  Washington State University, Paul G Allen School for Global Animal Health

  PRINCIPAL INVESTIGATOR

• Josphat M Muema, PhD(c)

  Washington State University - Global Health Kenya

  STUDY DIRECTOR

• Mutono Nyamai, PhD(c)

  Washington State University - Global Health Kenya

  STUDY DIRECTOR

• Guy Palmer, PhD

  Washington State University, Paul G Allen School for Global Animal Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Data collection enumerators will not be aware which intervention arm the households belong to.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 29, 2020
• Study Start: September 4, 2019
• Primary Completion: December 31, 2021
• Study Completion: April 30, 2022
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: When the study articles have been published
• Access Criteria: On request

Locations

KE (1)