An Agricultural Livelihood Intervention for Pregnant Women
NCT07043647 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 410
Last updated 2025-12-12
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.
Conditions
- Food Insecurity
- Pregnancy
- Birth Outcomes
- Livelihood Interventions
- Infant Health Outcomes
Interventions
- OTHER
-
Shamba Maisha
The Shamba Maisha Intervention has three key parts: A. Agricultural Commodities: KickStart "Starter Pump" (\~$60 USD, 2.5 Kg), hosing, fertilizer, and seeds. B. Training: We developed model farms near each health facility where didactic and hands on training will be conducted. Our weekly didactic and practical skills training will rotate topics to ensure all participants receive full coverage. Women will be encouraged to invite a key farming support person to trainings. C. Model farm harvest: Participants will harvest vegetables at the model farms for their own consumption until their individual farms start producing in 6-8 weeks to ensure access to a nutritious diet from the time of enrollment.
Sponsors & Collaborators
-
Kenya Medical Research Institute
collaborator OTHER -
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
collaborator NIH -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Craig R Cohen, MD MPH · University of California, San Francisco
-
Pamela M Murnane, PhD MPH MLIS · University of California, San Francisco
-
Phelgona A Otieno, MBChB MMed MPH · Kenya Medical Research Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-09-05
- Primary Completion
- 2029-02-19
- Completion
- 2029-02-19
Countries
- Kenya
Study Locations
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