Food FARMacia: Reducing Childhood Obesity in Households With Food Insecurity

Launched by STANFORD UNIVERSITY · Sep 18, 2023

Keywords

ClinConnect Summary

The Food FARMacia study is testing a program designed to help families with young children who are struggling with food insecurity, which means they may not have enough healthy food to eat. This trial is looking for families with infants aged 6 to 18 months who receive care at Columbia / New York-Presbyterian. Participants will receive nutrition education and guidance on how to prepare healthy meals, along with their usual medical care.

To be eligible, children must be between 6 and 18 months old and come from households that have been identified as food insecure. Their mothers or primary caregivers must be at least 18 years old and able to participate in the study. Families can expect to learn about healthy eating and get support for preparing meals over a 6-month period. This trial is currently recruiting participants, and it's a great opportunity for families looking to improve their nutrition and overall health.

Gender

ALL

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)