Actively Recruiting

Phase Not Applicable
Age: 16Years +
All Genders
Healthy Volunteers
ID07043647

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

Led by University of California, San Francisco · Updated on 2025-12-12

410

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of California, San Francisco

Lead Sponsor

K

Kenya Medical Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate whether an agricultural intervention can reduce food scarcity and improve health outcomes among pregnant women and their infants in sub-Saharan Africa. The study focuses on 410 pregnant women, half living with HIV, enrolled between 9 and 20 weeks of pregnancy. It seeks to understand how sustainable farming skills and resources might enhance maternal and infant health, socioeconomic status, and behavior during pregnancy and up to 12 months after birth. Participants are randomly assigned to either receive the agricultural intervention immediately or to receive it after the study concludes. The intervention includes providing agricultural supplies such as irrigation pumps, seeds, and fertilizers, along with training in agriculture, agribusiness, and safety. A model farm is also used for training and to supply vegetables until participants' farms begin producing. Control participants receive the full intervention after study follow-up. During the study, women will be monitored through clinical and physical measurements at multiple time points: 30 and 36 weeks gestation, delivery, and 6 weeks, 3, 6, 9, and 12 months postpartum. Researchers will assess infant length, birth weight, household food insecurity, depression, infant stunting, and empowerment measures. The study includes follow-up for one year after birth to evaluate the intervention's impact on health and nutrition.

CONDITIONS

Brief Title

An Agricultural Livelihood Intervention for Pregnant Women

Who Can Participate

Age: 16Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women between 9 and 20 weeks gestation confirmed by ultrasound
  • Singleton pregnancy
  • Age 16 years or older
  • Moderate to severe household food insecurity or malnutrition (mid-upper arm circumference less than 23 cm)
  • Access to land and permanent surface water
  • Self-reported experience with farming
Not Eligible

You will not qualify if you...

  • Advanced HIV disease
  • Unable to provide written informed consent (an impartial witness may assist if illiterate)
  • Plans to relocate outside the study area within 18 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - From early pregnancy (9 to 20 weeks gestation) until delivery

Participants receive an agricultural livelihood intervention including supply of agricultural commodities, training in agriculture and agribusiness, and access to a model farm to support nutrition and farming skills during pregnancy.

Weekly training sessions and ongoing use of agricultural resources until delivery

Follow-up

Duration - From delivery to 12 months postpartum

Participants are followed up with clinical and anthropometric assessments to monitor maternal and infant health and nutrition outcomes postpartum.

Visits at delivery, 6 weeks, 3 months, 6 months, 9 months, and 12 months postpartum

Trial Site Locations

Total: 1 location

1

Kenya Medical Research Institute

Nairobi, Kenya

Actively Recruiting

Loading map...

Research Team

R

Rachel L Burger, MHS

P

Pamela M Murnane, PhD MPH MLIS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Similar Trials

Development and Validation of a Prediction Model for Adverse...

Aplastic Anemia

Actively Recruiting

1 location

A Repository to Study Host-Microbiome Interactions in Health...

Healthy Controls

Actively Recruiting

1 location

A Prospective Validation of the Enlighten Device in Predicti...

Postpartum Depression (PPD)

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here