Actively Recruiting

Phase Not Applicable
Age: 6Months +
All Genders
NCT06051591

Food FARMacia: Reducing Childhood Obesity in Households With Food Insecurity

Led by Stanford University · Updated on 2026-03-05

80

Participants Needed

2

Research Sites

173 weeks

Total Duration

On this page

Sponsors

S

Stanford University

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Food FARMacia: Reducing Childhood Obesity in Households With Food Insecurity

Who Can Participate

Age: 6Months +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Child aged 6 to less than 18 months at enrollment
  • Child born at gestational age 37 weeks or later without signs of undernutrition at routine healthcare visits
  • Child lives in a household with food insecurity based on the 2-item Hunger Vital Signs14 screening tool
  • Child is a primary pediatric care patient at Stanford University/Stanford Health Care Network
  • Planned continuation of primary pediatric care at Stanford University/Stanford Health Care
  • Child lives in a community setting with a caretaker enrolled in this study
  • Primary caretaker of eligible infant with planned enrollment in this study
  • Caretaker aged 18 years or older
  • Caretaker able to respond to questions in English and/or Spanish
  • Caretaker willing for self and infant to be randomized and to complete all study parts
  • Caretaker agrees to receive messages on mobile device, email, or place of residence
  • Caretaker agrees to complete all study procedures for self and infant
  • Caretaker capable of providing informed consent for self and infant
Not Eligible

You will not qualify if you...

  • Child born before 37 weeks gestation
  • Child was small-for-gestational age at birth (birth weight less than 10th percentile)
  • Child weight-for-length less than 3rd percentile
  • Child body mass index less than 5th percentile for age and sex
  • Child or household previously enrolled in this study or Food FARMacia program
  • Child has conditions that interfere with growth or mobility (e.g., complex congenital heart disease, cystic fibrosis)
  • Child has special diets (e.g., tyrosinemia, enteral tube feeding)
  • Child has chronic diseases that interfere with nutrition and growth as determined by investigators
  • Primary caretaker is pregnant at baseline visit
  • Primary caretaker younger than 18 years at baseline
  • Primary caretaker unable to complete study visits or intervention components
  • Primary caretaker unwilling or unable to commit to a 6-month study for self or infant
  • Primary caretaker unable to give informed consent
  • Primary caretaker has underlying disease or treatment that might interfere with study participation (e.g., significant gastrointestinal conditions, major psychiatric disorders)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Stanford University School of Medicine

Stanford, California, United States, 94305

Not Yet Recruiting

2

Columbia University Irving Medical Center

New York, New York, United States, 10032

Actively Recruiting

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Research Team

S

Study Coordinator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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