An Agricultural Livelihood Intervention for Pregnant Women

Not Applicable

Not yet recruiting

• Conditions: Food Insecurity; Pregnancy; Birth Outcomes; Livelihood Interventions; Infant Health Outcomes

• Registration Number: NCT07043647
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Food insecurity is a critical driver of maternal and infant health and nutrition, including poor birth outcomes, suboptimal breastfeeding, perinatal depression and stress, and poor child growth and development. Pregnant women living with HIV are particularly vulnerable to food insecurity and face an excess risk of poor birth and infant outcomes. In sub-Saharan Africa, where both food insecurity and HIV are highly prevalent and a third of children under five are stunted, interventions to reduce food insecurity and malnutrition that are relevant for women with and without HIV are needed. In rural settings in this region, small-scale farming is the primary source of livelihood, yet unpredictable rainfall, severe climate events, and limited irrigation hamper crop yields. Agricultural livelihood interventions are a promising approach to raising income, bolstering food security, and ultimately improving maternal and infant health and nutrition. However, studies of agricultural interventions initiated in pregnancy are lacking despite the fact that in utero exposures crucially predict pregnancy and infant outcomes. The overall objectives of this proposal are to determine the effectiveness of an agricultural livelihood intervention on improving maternal and infant health when initiated in early pregnancy, and to understand factors that influence implementation of the agricultural intervention in the perinatal period, including the need for farming support when pregnancy impacts women's capacity to work in the field.

This is a hybrid effectiveness implementation clinical trial among 410 pregnant women enrolled at ≤from 9 -20 weeks gestation, half living with HIV in western Kenya. Women will be randomized 1:1 to the intervention or routine care. The proposed agricultural intervention package will include: a. Supply of agricultural commodities of, irrigation pump, seeds and fertilizers b. Training in agriculture, agribusiness and safety c. Model farm to enhance training and earlier harvest for food. The intervention will be implemented soon after enrolment. The study aims include: Aim 1: Determine the impact of the intervention on maternal, pregnancy and infant health outcomes. Aim 2: Determine the impact of the intervention on empowerment, socioeconomic, and behavioral factors that may influence maternal and infant health. Aim 3: Identify attitudes, norms, processes, and resources that influence implementation outcomes and effectiveness of the intervention initiated in early pregnancy. Follow up with clinical and anthropometry measures will be conducted for all the enrolled participants at 30 weeks and 36 weeks, delivery, and at 6 weeks, 3 months, 6 months, 9 months, and 12 months postpartum. The central hypothesis is that by empowering pregnant women with skills and tools for sustainable farming and perinatal nutrition, the intervention will lead to improved maternal and infant health compared to control participants. An HIV status neutral approach will optimize the generalizability and potential reach of this intervention. Also, because HIV stigma and poor health present additional barriers to empowerment and healthy behaviors, this intervention, which may reduce these barriers, has the potential to alleviate infant health disparities associated with maternal HIV.

This proposed research is highly significant because it will address a critical gap in evidence of locally effective, acceptable, feasible, adaptable and scalable interventions that may lead to improved maternal and infant nutritional needs. We anticipate that a deliberate neutral HIV status approach is the best as it will enable generalizability for community applications.

Study Timeline

• Study First Submitted: 2025-06-20
• Study First Submitted QC: 2025-06-20
• Study First Posted: 2025-06-29
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-08
• Study Start: 2025-09-01
• Primary Completion: 2028-08
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 410

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Infant length for age at 12 months	12 months of age	z-score for length for age using the WHO Child Growth Standards
Birth Weight	Measured at birth	Birthweight measured to nearest 10 grams with a portable digital baby scale
Household Food Insecurity Scale (HFAIS)	Baseline, 30 weeks gestation, 36 weeks gestation, 6 weeks, 3 months, 6 months, and 12 months post-partum.	Household Food Insecurity Access Scale (HFIAS). Scores ranges from 0-27, with higher scores indicating higher food insecurity.

Secondary Outcome Measures

Name	Time	Method
Low Birthweight	Measured at Birth	\<2500 grams measured using a portable digital baby scale (Seca)
Preterm birth (PTB)	Measured at delivery	Gestational age at delivery \<37 weeks
Edinburgh Postnatal Depression Scale (EPDS)	Baseline, 30 weeks gestation, 36 weeks gestation, 6 weeks, 3 months, 6 months, and 12 months post-partum.	Scores range from 0 to 30, with higher scores indicating a greater likelihood of depression.
Stunting among infants	12 months of age	\<-2 z-score for length for age using the WHO Child Growth Standards
Sexual Relationship Power Scale (SRPS)	Baseline	Values for Relationship Control range from 15-60 with higher scores representing higher sexual relationship power

Trial Locations

Locations (1)

Kenya Medical Research Institute; 🇰🇪 Nairobi, Kenya