A Randomized Controlled Trial of an Agricultural Livelihood Intervention to Improve Maternal and Newborn Health and Nutrition in Kenya: Mama Shamba

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Scarcity of food is a leading cause of sickness and death in mothers and their newborns in sub-Saharan Africa. Use of locally acceptable agricultural interventions including provision of agricultural supplies, training and having model farms can go a long way to alleviate the ills of food scarcity among mothers and children in our region. This study is designed to learn whether an agricultural intervention might prevent food scarcity and illness among mothers and children. A total of 410 pregnant women will be enrolled from 9- 20 weeks of pregnancy, half living with HIV. Women will be randomly assigned to receive the intervention right away or to receive the intervention after the study is over if they are interested. Follow-up on enrolled participants will happen at a specified period of time, up to 12 months postpartum. The central hypothesis is that by empowering pregnant women with skills and commodities for sustainable farming, the intervention will lead to better maternal and infant health compared to control participants. The study intervention includes the provision of agricultural commodities (including irrigation pumps seeds, and other supplies) training on agriculture and business, and a demonstration farm where all trainings will be held and where women can harvest vegetables to bring home. The study aims to explore the impact of the intervention on health outcomes as well as socioeconomic and behavioral factors among the study population. This research will significantly advance scientific understanding of the importance of such agricultural interventions for pregnant women and their infants in the first year of life.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: t
View:

• Pregnant and 9-20 weeks gestation confirmed by ultrasound

• singleton pregnancy

• Age ≥16 years

• moderate-severe household food insecurity or malnutrition (mid-upper arm circumference (MUAC) \<23 cm)

• Access to land and permanent surface water

• self-reported experience with farming

Locations
Other Locations
Kenya
Kenya Medical Research Institute
RECRUITING
Nairobi
Contact Information
Primary
Rachel L Burger, MHS
rachel.burger@ucsf.edu
4155352651
Backup
Pamela M Murnane, PhD MPH MLIS
pamela.murnane@ucsf.edu
4159713119
Time Frame
Start Date: 2025-09-05
Estimated Completion Date: 2028-08
Participants
Target number of participants: 410
Treatments
Experimental: Agricultural tools and training
Provision of water pump, other supplies, training, and harvest from the demonstration farm in early pregnancy
No_intervention: Control Arm
Control participants will be offered the full intervention at the conclusion of study follow-up.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco
Collaborators: Kenya Medical Research Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov