Food FARMacia: Reducing Childhood Obesity in Households With Food Insecurity
- Conditions
- Nutrition, Healthy
- Interventions
- Behavioral: Self-directed meal preparation supportBehavioral: Food FARMacia Program
- Registration Number
- NCT06051591
- Lead Sponsor
- Stanford University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Attention Control Self-directed meal preparation support Participants will receive nutrition education and anticipatory guidance to support healthy meal preparation in addition to usual care. Food FARMacia intervention Self-directed meal preparation support 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. Food FARMacia intervention Food FARMacia Program 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.
- Primary Outcome Measures
Name Time Method Recruitment feasibility 24 months Completion of enrollment of 80 households within the study timeframe
Retention Rate 6 months At least 70% with complete follow-up visits at 6-month follow-up
Attendance Rate (Proportion of food distributions attended/received) - Intervention Arm 6 months At least 70% median attendance rate for twice monthly food distributions at 6-month follow-up
Intervention Satisfaction - Intervention Arm 6 months 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Stanford University School of Medicine
🇺🇸Stanford, California, United States
Columbia University Irving Medical Center
🇺🇸New York, New York, United States