An Agricultural Livelihood Intervention for Pregnant Women

NCT07043647 | Recruiting

• 1 other identifier: R01HD116651
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Insecurity; Pregnancy; Birth Outcomes; Infant Health Outcomes; Livelihood Interventions

Keywords

Food Insecurity; Pregnancy; Birth Outcomes; Livelihood interventions; agricultural Interventions; Kenya

Outcome Measures

Primary Outcomes (3)

• Infant length for age at 12 months

  z-score for length for age using the WHO Child Growth Standards

  12 months of age

• Birth Weight

  Birthweight measured to nearest 10 grams with a portable digital baby scale

  Measured at birth

• Household Food Insecurity Scale (HFAIS)

  Household Food Insecurity Access Scale (HFIAS). Scores ranges from 0-27, with higher scores indicating higher food insecurity.

  Baseline, 30 weeks gestation, 36 weeks gestation, 6 weeks, 3 months, 6 months, and 12 months post-partum.

Secondary Outcomes (5)

• Low Birthweight

  Measured at Birth

• Preterm birth (PTB)

  Measured at delivery

• Edinburgh Postnatal Depression Scale (EPDS)

  Baseline, 30 weeks gestation, 36 weeks gestation, 6 weeks, 3 months, 6 months, and 12 months post-partum.

• Stunting among infants

  12 months of age

• Sexual Relationship Power Scale (SRPS)

  Baseline

Study Arms (2)

Agricultural tools and training

EXPERIMENTAL

Provision of water pump, other supplies, training, and harvest from the demonstration farm in early pregnancy

Other: Shamba Maisha

Control Arm

NO INTERVENTION

Control participants will be offered the full intervention at the conclusion of study follow-up.

Interventions

Shamba Maisha OTHER

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.

Agricultural tools and training

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Kenya Medical Research Institute: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Kenya Medical Research Institute

Nairobi, Kenya

RECRUITING

Study Officials

• Craig R Cohen, MD MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Pamela M Murnane, PhD MPH MLIS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Phelgona A Otieno, MBChB MMed MPH

  Kenya Medical Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel L Burger, MHS

CONTACT

4155352651; rachel.burger@ucsf.edu

Pamela M Murnane, PhD MPH MLIS

CONTACT

4159713119; pamela.murnane@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: June 29, 2025
• Study Start: September 5, 2025
• Primary Completion (Estimated): February 19, 2029
• Study Completion (Estimated): February 19, 2029
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)