NCT07043647 An Agricultural Livelihood Intervention for Pregnant Women
| NCT ID | NCT07043647 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Food Insecurity |
| Study Type | INTERVENTIONAL |
| Enrollment | 410 participants |
| Start Date | 2025-09-05 |
| Primary Completion | 2029-02-19 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Advanced HIV disease * Unable to provide written informed consent (use of an impartial witness is satisfactory if illiterate) * Plans to relocate outside the study area within 18 months