Status:
RECRUITING
Food FARMacia: Reducing Childhood Obesity in Households With Food Insecurity
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Nutrition, Healthy
Eligibility:
All Genders
6+ years
Phase:
NA
Brief 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 receivin...
Detailed Description
Childhood obesity remains highly prevalent and originates early in life. Efficacious early life interventions to prevent childhood obesity are lacking, particularly among populations most burdened by ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06051591
Start Date
December 1 2023
End Date
March 31 2026
Last Update
November 26 2024
Active Locations (2)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305
2
Columbia University Irving Medical Center
New York, New York, United States, 10032