An Agricultural Livelihood Intervention for Pregnant Women

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Shamba Maisha

    Other intervention

    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.

Treatment groups

410 Participants
are divided into 2 treatment groups
Group A: Agricultural tools and trainingExperimental treatment 1 intervention
Group B: Control ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Infant length for age at 12 months

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

Time frame
12 months of age
2

Birth Weight

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

Time frame
Measured at birth
3

Household Food Insecurity Scale (HFAIS)

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

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

Secondary outcomes

1

Low Birthweight

\<2500 grams measured using a portable digital baby scale (Seca)

Time frame
Measured at Birth
2

Preterm birth (PTB)

Gestational age at delivery \<37 weeks

Time frame
Measured at delivery
3

Edinburgh Postnatal Depression Scale (EPDS)

Scores range from 0 to 30, with higher scores indicating a greater likelihood of depression.

Time frame
Baseline, 30 weeks gestation, 36 weeks gestation, 6 weeks, 3 months, 6 months, and 12 months post-partum.
4

Stunting among infants

\<-2 z-score for length for age using the WHO Child Growth Standards

Time frame
12 months of age

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Kenya Medical Research Institute

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator