Food FARMacia: Reducing Childhood Obesity in Households With Food Insecurity
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 at Columbia / New York-Presbyterian Ambulatory Care Network. All participants will receive nutrition education and anticipatory guidance to support healthy meal preparation in addition to usual care.
Conditions:
🦠 Nutrition, Healthy
🗓️ Study Start (Actual) 1 December 2023
🗓️ Primary Completion (Estimated) March 2025
✅ Study Completion (Estimated) March 2026
👥 Enrollment (Estimated) 80
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

  • Inclusion Criteria for Child:
  • * Age 6 to \< 18 months at enrollment
  • * In household with food insecurity documented in the electronic health record (EHR) before infant age 18 months
  • * 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 in the Columbia / NYP Ambulatory Care Network
  • * Planned continuation of primary pediatric care at Columbia/NYP
  • * 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, including plans to move \>25 miles from CUIMC within the next 6 months
  • * 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)
Ages Eligible for Study: 6 Months to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 September 2023
  • First Submitted that Met QC Criteria 18 September 2023
  • First Posted 25 September 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 12 February 2024
  • Last Update Posted 13 February 2024
  • Last Verified February 2024