Food FARMacia: Reducing Childhood Obesity in Households With Food Insecurity

NCT06051591 | Recruiting DMC

• 2 other identifiers: 76726R01DK134463
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Nutrition, Healthy

Keywords

Childhood Obesity; Food Insecurity

Outcome Measures

Primary Outcomes (4)

• Recruitment feasibility

  Completion of enrollment of 80 households within the study timeframe

  24 months

• Retention Rate

  At least 70% with complete follow-up visits at 6-month follow-up

  6 months

• Attendance Rate (Proportion of food distributions attended/received) - Intervention Arm

  At least 70% median attendance rate for twice monthly food distributions at 6-month follow-up

  6 months

• Intervention Satisfaction - Intervention Arm

  Average report of agree or strongly agree (mean score 4 or higher on a 5-point scale) with intervention satisfaction at 6-month follow-up

  6 months

Study Arms (2)

Attention Control

ACTIVE COMPARATOR

Participants will receive nutrition education and anticipatory guidance to support healthy meal preparation in addition to usual care.

Behavioral: Self-directed meal preparation support

Food FARMacia intervention

EXPERIMENTAL

Participants will enroll in the Food FARMacia program and receive groceries twice monthly for 6 months. They will also receive nutrition education and anticipatory guidance to support healthy meal preparation.

Behavioral: Food FARMacia Program; Behavioral: Self-directed meal preparation support

Interventions

Food FARMacia Program BEHAVIORAL

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

Food FARMacia intervention

Self-directed meal preparation support BEHAVIORAL

Nutrition education and anticipatory guidance to support healthy meal preparation

Attention Control; Food FARMacia intervention

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Stanford University School of Medicine

Stanford, California, 94305, United States

NOT YET RECRUITING

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Woo Baidal, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

646-369-5048; cropnutrition@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will not be masked as they will be receiving twice monthly groceries if they are enrolled in the Food FARMacia program.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months after peer-reviewed publication and up to 36 months after publication.
• Access Criteria: Investigators who provide a proposal for data use that is approved by the study investigators. Information on submitting proposals and accessing data may be obtained by emailing the study PI and coordinator. A signed data use agreement will be required.

Locations

US (2)