Food InsecurityNCT07043647
An Agricultural Livelihood Intervention for Pregnant Women
A study of Food Insecurity and Pregnancy, run by University of California, San Francisco at 1 site in Kenya.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity, Pregnancy, Birth Outcomes
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 410 participants
- Where
- 1 siteKenya
- Study dates
- 5 Sep 2025to 19 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya1 site, 1 recruiting
- Recruiting
Kenya Medical Research Institute
Nairobi
Prisca Lihanda, plihanda@gmail.com
Elly Weke, MS, otielly@yahoo.com
About this study
Official title: A Randomized Controlled Trial of an Agricultural Livelihood Intervention to Improve Maternal and Newborn Health and Nutrition in Kenya: Mama Shamba
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.
Read the 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.
- Conditions
- Food Insecurity, Pregnancy, Birth Outcomes, Livelihood Interventions, Infant Health Outcomes
- Being tested
- Shamba Maisha
- Keywords
- Food Insecurity, Pregnancy, Birth Outcomes, Livelihood interventions, agricultural Interventions, Kenya
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shamba MaishaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Agricultural tools and training | Experimental | Provision of water pump, other supplies, training, and harvest from the demonstration farm in early pregnancy Receives: Other: Shamba Maisha |
| Control Arm | No intervention | Control participants will be offered the full intervention at the conclusion of study follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant length for age at 12 months
z-score for length for age using the WHO Child Growth Standards
Measured: 12 months of age
Birth Weight
Birthweight measured to nearest 10 grams with a portable digital baby scale
Measured: 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.
Measured: Baseline, 30 weeks gestation, 36 weeks gestation, 6 weeks, 3 months, 6 months, and 12 months post-partum.
Secondary outcomes (5)
Low Birthweight
<2500 grams measured using a portable digital baby scale (Seca)
Measured: Measured at Birth
Preterm birth (PTB)
Gestational age at delivery <37 weeks
Measured: Measured at delivery
Edinburgh Postnatal Depression Scale (EPDS)
Scores range from 0 to 30, with higher scores indicating a greater likelihood of depression.
Measured: Baseline, 30 weeks gestation, 36 weeks gestation, 6 weeks, 3 months, 6 months, and 12 months post-partum.
Stunting among infants
<-2 z-score for length for age using the WHO Child Growth Standards
Measured: 12 months of age
Sexual Relationship Power Scale (SRPS)
Values for Relationship Control range from 15-60 with higher scores representing higher sexual relationship power
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start5 Sep 2025
- Primary completion19 Feb 2029 (estimated)
- Study completion19 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Craig R Cohen, MD MPH, Principal investigator, University of California, San FranciscoPamela M Murnane, PhD MPH MLIS, Principal investigator, University of California, San FranciscoPhelgona A Otieno, MBChB MMed MPH, Principal investigator, Kenya Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043647
- Sponsor's protocol ID
- R01HD116651
- Other IDs
- R01HD116651
- Status last verified
- Dec 2025
- First submitted
- 20 Jun 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of an Agricultural Livelihood Intervention to Improve Maternal and Newborn Health and Nutrition in Kenya: Mama Shamba
- ClinicalTrials.gov ID
- NCT07043647
- Acronym / sponsor ID
- R01HD116651
- Conditions
- Food Insecurity, Pregnancy, Birth Outcomes, Livelihood Interventions, Infant Health Outcomes
- Keywords
- Food Insecurity, Pregnancy, Birth Outcomes, Livelihood interventions, agricultural Interventions, Kenya
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 19 Feb 2029 (estimated)
- Study completion
- 19 Feb 2029 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Agricultural tools and training | Experimental | Other: Shamba MaishaProvision of water pump, other supplies, training, and harvest from the demonstration farm in early pregnancy |
| Control Arm | No intervention | –Control participants will be offered the full intervention at the conclusion of study follow-up. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shamba MaishaThe 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. | Other | Agricultural tools and training |
Primary outcome
Infant length for age at 12 months
Time frame: 12 months of age
z-score for length for age using the WHO Child Growth Standards
Birth Weight
Time frame: Measured at birth
Birthweight measured to nearest 10 grams with a portable digital baby scale
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.
Household Food Insecurity Access Scale (HFIAS). Scores ranges from 0-27, with higher scores indicating higher food insecurity.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Craig R Cohen, MD MPH principal investigator
University of California, San Francisco
Pamela M Murnane, PhD MPH MLIS principal investigator
University of California, San Francisco
Phelgona A Otieno, MBChB MMed MPH principal investigator
Kenya Medical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Food Insecurity and Pregnancy, run by University of California, San Francisco at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel L Burger, MHS (4155352651, rachel.burger@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant length for age at 12 months (time frame: 12 months of age). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.