Food FARMacia: Reducing Childhood Obesity in Households With Food Insecurity

This study, called Food FARMacia, is looking at whether a program to reduce food insecurity (not having enough food for an active, healthy life) is practical and accepted by families with young infants. The program involves twice-monthly delivery of groceries for up to six months, along with support for healthy meal preparation. All participants will also receive nutrition education. This study is for children aged 6 to less than 18 months who were born at 37 weeks or later, do not show signs of undernutrition, and live in a household experiencing food insecurity. The study aims to enroll 80 participants and is currently unclear on its recruitment status. Success will be measured by how many families join, stay in the study, and receive the food distributions.

Study design
This is an interventional study planning to enroll 80 participants. It is designed to test a behavioral intervention.
What's involved
Participants will receive twice-monthly grocery deliveries for six months and nutrition education. The study will track attendance at food distributions.
Compensation
Not stated in the trial record.
Follow-up
The study will track retention for 6 months and recruitment feasibility for 24 months.

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NCT06051591

Food FARMacia: Reducing Childhood Obesity in Households With Food Insecurity

Recruiting
NAAges 6+Interventional
Stanford University
~80 participants
Updated 2026-03-05 on ClinicalTrials.gov
What's tested:Food FARMacia ProgramSelf-directed meal preparation support

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recruitment feasibility
Measured over 24 months
+3 more outcomes measured
Nutrition, Healthy
2 sites across 2 states
California1
New York1
  • Jennifer Woo Baidal, MD · PRINCIPAL_INVESTIGATOR · Stanford University

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Eligibility criteria

Inclusion

Age 6 to \< 18 months at enrollment
Born gestational age 37 weeks or later without evidence of undernutrition at routine health care visits
In household with food insecurity at time of screening phone call based on an affirmative response on the 2-item Hunger Vital Signs™ screening tool
Primary pediatric care patient at Stanford University/Stanford Health Care Network
Planned continuation of primary pediatric care at Stanford University/Stanford Health Care
Living in a community setting (not inpatient or living in a nursing/long-term care setting) with a caretaker enrolled in this study
Primary caretaker of infant eligible for study and with planned enrollment in this study
Age 18 years or older
Ability to respond to questions in English and/or Spanish
Willing for self and infant to be randomized into a RCT and complete all study components
Gives permission to receive messages to their mobile device, email, and or place of residence
Gives permission to complete all study procedures for self and infant
Capable of providing informed consent for self and infant

Exclusion

Gestational age \< 37 weeks
Small-for-gestational age at birth (birth weight for gestational age less than 10th percentile)
Weight-for-length \< 3rd percentile
Body Mass Index \< 5th percentile for age and sex
Children in household previously enrolled in this study or the Food FARMacia program
Conditions that substantially interfere with growth or mobility (e.g., complex congenital heart disease, cystic fibrosis)
Children with special diets (e.g., tyrosinemia, enteral tube feeding)
Children with chronic diseases that interfere with nutrition and growth as determined by investigators
Pregnancy at baseline visit because of unique nutritional needs
Age \< 18 years at baseline because of unique developmental differences of adolescents and New York State regulations
Inability to complete study visits or intervention components
Unwillingness or inability to commit to a 6-month research study for self or infant
Unable to give informed consent
Underlying disease/treatment that might interfere with participation in/completion of the study (e.g., significant gastrointestinal conditions, major psychiatric disorders, and others at the discretion of the study clinician)
  • Recruitment feasibility24 months

    Completion of enrollment of 80 households within the study timeframe

  • Retention Rate6 months

    At least 70% with complete follow-up visits at 6-month follow-up

  • Attendance Rate (Proportion of food distributions attended/received) - Intervention Arm6 months

    At least 70% median attendance rate for twice monthly food distributions at 6-month follow-up

  • Intervention Satisfaction - Intervention Arm6 months

    Average report of agree or strongly agree (mean score 4 or higher on a 5-point scale) with intervention satisfaction at 6-month follow-up