An Agricultural Livelihood Intervention for Pregnant Women

NCT07043647 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2025-12-12

No results posted yet for this study

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07043647 on ClinicalTrials.gov