Recruiting

Childhood ObesityFood FARMacia: Reducing Childhood Obesity in Households With Food Insecurity

Sponsor:

Stanford University

Code:

NCT06051591

Conditions

Nutrition, Healthy

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Food FARMacia Program

Self-directed meal preparation support

Study Details

Brief summary:

The goal of this clinical trial is to test whether the Food FARMacia intervention to reduce food insecurity is feasible and accepted among families with an infant age 6 to less than 18 months receiving pediatric primary care.

All participants will receive nutrition education and anticipatory guidance to support healthy meal preparation in addition to usual care.

Conditions

Nutrition, Healthy

Study ID

NCT06051591

Start date

Dec 1, 2023

Status verified date

Mar, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Jan 15, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria for Child:

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

Exclusion Criteria for Child:

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

Inclusion Criteria for Parent/Legal Guardian:

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 Criteria for Parent/Legal Guardian:

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)

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Attention Control

Participants will receive nutrition education and anticipatory guidance to support healthy meal preparation in addition to usual care.

experimental: Food FARMacia intervention

Participants will enroll in the Food FARMacia program and receive groceries twice monthly for 6 months. They will also receive nutrition education and anticipatory guidance to support healthy meal preparation.

Interventions

Food FARMacia Program

Twice monthly delivery of groceries with about 12 meals per household member for up to 4 household members for 6 months.

Self-directed meal preparation support

Nutrition education and anticipatory guidance to support healthy meal preparation

Primary outcome measure

Recruitment feasibility [ Time Frame: 24 months ]
Retention Rate [ Time Frame: 6 months ]
Attendance Rate (Proportion of food distributions attended/received) - Intervention Arm [ Time Frame: 6 months ]
Intervention Satisfaction - Intervention Arm [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Study Coordinator

646-369-5048 cropnutrition@stanford.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Ali Mencin, MD

am2363@cumc.columbia.edu

Principal Investigator:

Ali Mencin, MD

More Information

Sponsor

Stanford University

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

Childhood Obesity
Food Insecurity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-03-05.