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NCT06051591Recruiting

Food FARMacia: Reducing Childhood Obesity in Households With Food Insecurity

Source: ClinicalTrials.gov · Last updated 5 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
80 (estimated)
First submitted
18 Sept 2023
Start date
1 Dec 2023
Primary completion date
15 Jan 2027
Lead sponsor
Stanford University
Diseases
Obesity
NCT number
NCT06051591

What you commit to

  • Study type: Interventional
  • Planned participants: 80
  • From 1 Dec 2023 to the primary completion date, 15 Jan 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Children in household previously enrolled in this study or the Food FARMacia program

Other illness

  • Conditions that substantially interfere with growth or mobility (e.g., complex congenital heart disease, cystic fibrosis)
  • Children with chronic diseases that interfere with nutrition and growth as determined by investigators
  • 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)

Age

  • Gestational age \< 37 weeks
  • Small-for-gestational age at birth (birth weight for gestational age less than 10th percentile)
  • Body Mass Index \< 5th percentile for age and sex
  • Age \< 18 years at baseline because of unique developmental differences of adolescents and New York State regulations

Other

  • Weight-for-length \< 3rd percentile
  • Children with special diets (e.g., tyrosinemia, enteral tube feeding)
  • Pregnancy at baseline visit because of unique nutritional needs
  • 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

Who the study is looking for

  • 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

Age in the registry: 6 months to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Columbia University Irving Medical Center
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Stanford University School of Medicine
Coordinator of this site? Confirm its status
StanfordUnited StatesNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.