Agricultural livelihood support for pregnant women to improve food security and birth outcomes
A Randomized Controlled Trial of an Agricultural Livelihood Intervention to Improve Maternal and Newborn Health and Nutrition in Kenya: Mama Shamba
This program will test whether giving pregnant women farming supplies, training, and access to model farms can reduce household food insecurity and improve birth and infant health for women with and without HIV.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 410 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (Nairobi) |
| Trial ID | NCT07043647 on ClinicalTrials.gov |
What this trial studies
This randomized trial will enroll 410 pregnant women between 9 and 20 weeks' gestation, roughly half of whom are expected to be living with HIV. Participants will be randomly assigned to receive an agricultural livelihood intervention immediately or to receive it after study completion (delayed entry). The intervention includes provision of locally acceptable farming supplies, training, and use of model farms, with implementation support during the perinatal period. Outcomes include household food security, maternal nutrition and health, birth outcomes, and infant growth and development, with follow-up through 12 months postpartum.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 16 or older at 9–20 weeks' gestation with moderate-to-severe household food insecurity or MUAC <23 cm, who have access to land and permanent surface water and some farming experience.
Not a fit: People without access to land or permanent water, those with advanced HIV disease (an exclusion), women beyond the 9–20 week enrollment window, or those planning to relocate within 18 months are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the intervention could increase household food security and maternal nutrition, leading to fewer adverse birth outcomes and better infant growth.
How similar studies have performed: Some agricultural livelihood programs have improved household food security and income in similar settings, but interventions started during pregnancy are largely untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nairobi
- Kenya Medical Research Institute — Nairobi, Kenya (Recruiting)
Study contacts
- Principal investigator: Craig R Cohen, MD MPH — University of California, San Francisco
- Study coordinator: Rachel L Burger, MHS
- Email: rachel.burger@ucsf.edu
- Phone: 4155352651
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.