Food FARMacia: Reducing Childhood Obesity in Households With Food Insecurity

NCT ID: NCT06051591

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2026-03-31

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.

Conditions

Nutrition, Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Attention Control

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

Group Type: ACTIVE_COMPARATOR

Self-directed meal preparation support

Intervention Type: BEHAVIORAL

Nutrition education and anticipatory guidance to support healthy meal preparation

Food FARMacia intervention

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.

Group Type: EXPERIMENTAL

Food FARMacia Program

Intervention Type: BEHAVIORAL

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

Self-directed meal preparation support

Intervention Type: BEHAVIORAL

Nutrition education and anticipatory guidance to support healthy meal preparation

Interventions

Food FARMacia Program

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

Intervention Type: BEHAVIORAL

Self-directed meal preparation support

Nutrition education and anticipatory guidance to support healthy meal preparation

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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)

• Minimum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Woo Baidal

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Woo Baidal, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Site Status: NOT_YET_RECRUITING

Columbia University Irving Medical Center

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Study Coordinator

Role: CONTACT

cropnutrition@stanford.edu

646-369-5048

Facility Contacts

Jennifer Woo Baidal, MD

Role: primary

jwoo1@stanford.edu

Ali Mencin, MD

Role: primary

am2363@cumc.columbia.edu

Other Identifiers

R01DK134463

Identifier Type: NIH

Identifier Source: secondary_id

View Link

76726

Identifier Type: -

Identifier Source: org_study_id