Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Malnutrition
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Factorial AssignmentIntervention 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 (Participant, Investigator)Masking Description: Data collection enumerators will not be aware which intervention arm the households belong to.Primary Purpose: Prevention

Participation Requirements

Age
Younger than 660 years
Gender
Both males and females

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 pr...

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.

Tracking Information

NCT #
NCT04608656
Collaborators
  • Food and Agriculture Organization of the United Nations
  • UNICEF
Investigators
Principal Investigator: Thumbi Mwangi, PhD Washington State University, Paul G Allen School for Global Animal Health Study Director: Josphat M Muema, PhD(c) Washington State University - Global Health Kenya Study Director: Mutono Nyamai, PhD(c) Washington State University - Global Health Kenya Study Chair: Guy Palmer, PhD Washington State University, Paul G Allen School for Global Animal Health