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Official title Food FARMacia: Reducing Childhood Obesity in Households With Food Insecurity
ClinicalTrials.gov ID: NCT06051591
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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 assigned by chance 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...
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
- New York, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.