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RecruitingNCT06051591Updated Mar 5, 2026

Food FARMacia: Reducing Childhood Obesity in Households With Food Insecurity

An interventional study of Food FARMacia Program and Self-directed meal preparation support in Nutrition, Healthy, sponsored by Stanford University. Recruiting at 2 sites in United States. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2026-03-05.

Sponsored by Stanford University · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Dec 2023; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
6 Months and older
Sex
All
01

Study 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.

Read the detailed description

Childhood obesity remains highly prevalent and originates early in life. Efficacious early life interventions to prevent childhood obesity are lacking, particularly among populations most burdened by childhood obesity. Food insecurity - defined as lack of enough food for an active, healthy life - may play key upstream roles in etiologies of obesity through establishment of unhealthy dietary patterns and stress-related metabolic perturbations. Household food insecurity during the first 24 months of life is a risk factor for later childhood obesity. Professional organizations recommend integration of household food insecurity screening into routine pediatric primary care. Yet, a critical gap exists in identification of efficacious clinical interventions to reduce food insecurity. Another gap exists in understanding relationships between food insecurity and etiologies of obesity. Food FARMacia is a clinically based mobile food pantry intervention developed to address the high prevalence of food insecurity among pediatric patients. No randomized trials of a clinically-based mobile food pantry intervention in pediatric primary care exist. To understand the role of food insecurity in etiologies of childhood obesity, efficacious interventions to reduce food insecurity are needed.

Household food insecurity during infancy is a risk factor for later childhood obesity. In this pilot and feasibility study, the investigators will randomly assign infants and their parent in households with food insecurity to either 1) the Food FARMacia mobile food pantry intervention with twice monthly food distributions and self-directed meal preparation support or 2) self-directed meal preparation support. Infants age 6 to \<18 months who are patients at Stanford University/Stanford Health Care who screen positive for food insecurity will potentially be eligible participants for recruitment. Parents will be asked to respond to survey questions about health behaviors for themself and their infant at baseline and follow-up.

The investigators will measure vital signs (e.g., weight and height/length) for parents and infants at baseline and follow-up. The investigators will examine feasibility, acceptability, and satisfaction with the study procedures and intervention materials. The investigators will estimate intervention effects on infant weight characteristics and explore potential mediators such as reduction in food insecurity and changes in nutrition and other established obesity risk factors to inform a subsequent full-scale trial. If successful, results will lead to a full-scale trial to test effects of the intervention on food insecurity, nutrition, and infant growth. Eventually, these study results could transform clinical care to reduce childhood obesity.

02

Conditions studied

  • Nutrition, Healthy

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Keywords

  • Childhood Obesity
  • Food Insecurity
03

In context

Pediatric Obesity

1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.

This study's planned enrollment of 80 is below the median of 103 across 862 interventional studies indexed under Pediatric Obesity.

Browse Pediatric Obesity studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    Attention Control

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

    Behavioral: Self-directed meal preparation support

  • 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.

    Behavioral: Food FARMacia Program · Behavioral: Self-directed meal preparation support

Interventions

  • BehavioralFood FARMacia Program

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

  • BehavioralSelf-directed meal preparation support

    Nutrition education and anticipatory guidance to support healthy meal preparation

06

What researchers measure

Primary outcomes

  1. Recruitment feasibility

    Completion of enrollment of 80 households within the study timeframe

    Time frame: 24 months

  2. Retention Rate

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

    Time frame: 6 months

  3. Attendance Rate (Proportion of food distributions attended/received) - Intervention Arm

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

    Time frame: 6 months

  4. Intervention Satisfaction - Intervention Arm

    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

    Time frame: 6 months

07

Study locations

1 of 2 sites recruiting
  • Stanford University School of Medicine
    Stanford, California 94305, United States
    • Jennifer Woo Baidal, MD · Contact · jwoo1@stanford.edu
    • Jennifer Woo Baidal, MD · Principal investigator
    Not yet recruiting
  • Columbia University Irving Medical Center
    New York, New York 10032, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — De-identified participant level data

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06051591
Lead sponsor
Stanford University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Jennifer Woo Baidal (Associate Professor of Pediatrics, Stanford University) — Principal investigator
First posted
Sep 25, 2023
Start date
Dec 1, 2023
Primary completion
Jan 15, 2027 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Mar 5, 2026

Study contacts

Study Coordinator
Contact
cropnutrition@stanford.edu
646-369-5048
Jennifer Woo Baidal, MD
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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