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Food FARMacia: Reducing Childhood Obesity in Households With Food Insecurity

Food FARMacia: Reducing Childhood Obesity in Households With Food Insecurity

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06051591
Enrollment
80
Registered
2023-09-25
Start date
2023-12-01
Completion date
2027-03-31
Last updated
2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition, Healthy

Keywords

Childhood Obesity, Food Insecurity

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 receiving pediatric primary care. All participants will receive nutrition education and anticipatory guidance to support healthy meal preparation in addition to usual care.

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 childhood obesity. Food insecurity - defined as lack of enough food for an active, healthy life - may play key upstream roles in etiologies of obesity through establishment of unhealthy dietary patterns and stress-related metabolic perturbations. Household food insecurity during the first 24 months of life is a risk factor for later childhood obesity. Professional organizations recommend integration of household food insecurity screening into routine pediatric primary care. Yet, a critical gap exists in identification of efficacious clinical interventions to reduce food insecurity. Another gap exists in understanding relationships between food insecurity and etiologies of obesity. Food FARMacia is a clinically based mobile food pantry intervention developed to address the high prevalence of food insecurity among pediatric patients. No randomized trials of a clinically-based mobile food pantry intervention in pediatric primary care exist. To understand the role of food insecurity in etiologies of childhood obesity, efficacious interventions to reduce food insecurity are needed. Household food insecurity during infancy is a risk factor for later childhood obesity. In this pilot and feasibility study, the investigators will randomly assign infants and their parent in households with food insecurity to either 1) the Food FARMacia mobile food pantry intervention with twice monthly food distributions and self-directed meal preparation support or 2) self-directed meal preparation support. Infants age 6 to \<18 months who are patients at Stanford University/Stanford Health Care who screen positive for food insecurity will potentially be eligible participants for recruitment. Parents will be asked to respond to survey questions about health behaviors for themself and their infant at baseline and follow-up. The investigators will measure vital signs (e.g., weight and height/length) for parents and infants at baseline and follow-up. The investigators will examine feasibility, acceptability, and satisfaction with the study procedures and intervention materials. The investigators will estimate intervention effects on infant weight characteristics and explore potential mediators such as reduction in food insecurity and changes in nutrition and other established obesity risk factors to inform a subsequent full-scale trial. If successful, results will lead to a full-scale trial to test effects of the intervention on food insecurity, nutrition, and infant growth. Eventually, these study results could transform clinical care to reduce childhood obesity.

Interventions

BEHAVIORALFood FARMacia Program

Twice monthly delivery of groceries with about 12 meals per household member for up to 4 household members for 6 months.

BEHAVIORALSelf-directed meal preparation support

Nutrition education and anticipatory guidance to support healthy meal preparation

Sponsors

Stanford University
Lead SponsorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Masking description

Participants will not be masked as they will be receiving twice monthly groceries if they are enrolled in the Food FARMacia program.

Intervention model description

Participants will be randomized and assigned to enroll in the Food FARMacia program for the duration of the study period or to receive usual care.

Eligibility

Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recruitment feasibility24 monthsCompletion of enrollment of 80 households within the study timeframe
Retention Rate6 monthsAt least 70% with complete follow-up visits at 6-month follow-up
Attendance Rate (Proportion of food distributions attended/received) - Intervention Arm6 monthsAt least 70% median attendance rate for twice monthly food distributions at 6-month follow-up
Intervention Satisfaction - Intervention Arm6 monthsAverage report of agree or strongly agree (mean score 4 or higher on a 5-point scale) with intervention satisfaction at 6-month follow-up

Countries

United States

Contacts

CONTACTStudy Coordinator
cropnutrition@stanford.edu646-369-5048
PRINCIPAL_INVESTIGATORJennifer Woo Baidal, MD

Stanford University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026