An Agricultural Livelihood Intervention for Pregnant Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Shamba Maisha.
- Who it may be relevant to
- Registry conditions: Food Insecurity, Pregnancy, Birth Outcomes, Livelihood Interventions. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kenya
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Trial of an Agricultural Livelihood Intervention to Improve Maternal and Newborn Health and Nutrition in Kenya: Mama Shamba
Overview
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.
Interventions
- Other Shamba Maisha
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: Pa
Primary outcome measures
- Infant length for age at 12 months [Time frame: 12 months of age]
- Birth Weight [Time frame: Measured at birth]
- Household Food Insecurity Scale (HFAIS) [Time frame: Baseline, 30 weeks gestation, 36 weeks gestation, 6 weeks, 3 months, 6 months, and 12 months post-partum.]
Secondary outcome measures (5)
- Low Birthweight [Time frame: Measured at Birth]
- Preterm birth (PTB) [Time frame: Measured at delivery]
- Edinburgh Postnatal Depression Scale (EPDS) [Time frame: Baseline, 30 weeks gestation, 36 weeks gestation, 6 weeks, 3 months, 6 months, and 12 months post-partum.]
- Stunting among infants [Time frame: 12 months of age]
- Sexual Relationship Power Scale (SRPS) [Time frame: Baseline]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Kenya · 1 center
- Kenya Medical Research Institute — Nairobi
Identifiers
NCT: NCT07043647 · R01HD116651 · R01HD116651