RecruitingNot ApplicableNCT06051591

Food FARMacia: Reducing Childhood Obesity in Households With Food Insecurity

Sponsor

Stanford University

Enrollment

80 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Nutrition, Healthy

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.

Eligibility

Min Age: 6 Months

Inclusion Criteria13

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

Exclusion Criteria14

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
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)