Reducing childhood obesity in families facing food insecurity
Food FARMacia: Reducing Childhood Obesity in Households With Food Insecurity
NA · Stanford University · NCT06051591
This study is testing a new program that helps families with young children who don’t have enough food learn about nutrition and prepare healthy meals to see if it can reduce childhood obesity.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 6 Months and up |
| Sex | All |
| Sponsor | Stanford University (other) |
| Locations | 2 sites (Stanford, California and 1 other locations) |
| Trial ID | NCT06051591 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the feasibility and acceptance of the Food FARMacia intervention, which provides nutrition education and meal preparation support to families with infants aged 6 to less than 18 months who are experiencing food insecurity. The intervention is designed to address the high prevalence of food insecurity and its link to childhood obesity by integrating a mobile food pantry into pediatric primary care. Participants will receive both the Food FARMacia program and usual care to promote healthy dietary habits and reduce the risk of obesity. The study seeks to fill critical gaps in effective interventions for food insecurity and its impact on childhood obesity.
Who should consider this trial
Good fit: Ideal candidates for this study are infants aged 6 to less than 18 months living in households identified as food insecure.
Not a fit: Patients who are not experiencing food insecurity or those with specific health conditions that disqualify them from the study may not benefit.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the risk of childhood obesity in families facing food insecurity.
How similar studies have performed: While no randomized trials of a clinically-based mobile food pantry intervention in pediatric primary care exist, the approach is innovative and aims to address a significant public health issue.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Stanford, California and 1 other locations
- Stanford University School of Medicine — Stanford, California, United States (NOT_YET_RECRUITING)
- Columbia University Irving Medical Center — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Jennifer Woo Baidal, MD — Stanford University
- Study coordinator: Study Coordinator
- Email: cropnutrition@stanford.edu
- Phone: 646-369-5048
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nutrition, Healthy, Childhood Obesity, Food Insecurity