Food Security Program for Food Insecurity
(I-FRESH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to improve health outcomes for children by connecting families experiencing food insecurity (lacking consistent access to enough food) with community-based nutrition support programs. It targets families with children attending specific clinics for conditions like type 2 diabetes, obesity, high blood pressure, or liver problems, who need better access to healthy foods. The trial seeks to refine methods for linking healthcare with food support systems, promoting healthier eating habits and empowering families to manage their health. Families with children attending certain clinics and facing food insecurity may be well-suited for this study. As a Phase 2 trial, this research measures the intervention's effectiveness in an initial, smaller group, offering families a chance to benefit from targeted support.
Do I have to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on food security and nutrition support, so it's unlikely that medication changes are required.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that programs addressing food insecurity can be safe and beneficial for individuals with certain health conditions. For instance, studies have explored how food programs can improve health in those with type 2 diabetes, obesity, heart problems, and digestive issues.
In the Type 2 Diabetes Clinic, research indicates that addressing food insecurity can lead to better diabetes outcomes, such as improved blood sugar levels, without major safety concerns.
In the Obesity Clinic, research presents mixed evidence on the effectiveness of these programs, but they do not pose significant safety risks.
In the Preventive Cardiology Clinic, studies have shown that food insecurity is linked to a higher risk of heart problems. Programs providing food support aim to reduce these risks, and no major safety issues have been reported.
In the Gastroenterology Clinic, food insecurity is associated with consuming unhealthy, high-calorie foods. Programs that identify and support families can help reduce this risk without known safety concerns.
Overall, these programs appear well-tolerated and do not report serious safety problems. They focus on improving access to healthy foods, which can lead to better health outcomes.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores the impact of addressing food insecurity as a way to improve health outcomes for children with conditions like type 2 diabetes, obesity, hypertension, high cholesterol, malnutrition, and MASLD. Unlike traditional treatments that focus solely on medication or lifestyle changes, this approach integrates food referrals into healthcare, aiming to tackle the root cause of food-related health issues. By providing families with access to nutritious food, the trial hopes to not only manage these conditions more effectively but also promote long-term health and equity. This method could revolutionize how we think about treating chronic health conditions by emphasizing the importance of nutrition and food security.
What evidence suggests that this trial's treatments could be effective for improving food security and health outcomes in children?
This trial will explore the impact of food insecurity on health across various clinics. Research has shown that insufficient food can harm health, especially in children. In the Type 2 Diabetes Clinic arm, participants will be assessed for how better access to healthy foods can improve diet quality and health, such as better blood sugar control. The Obesity Clinic arm will focus on how food insecurity might affect weight loss, emphasizing the benefits of eating more fruits and vegetables. The Preventive Cardiology Clinic arm will examine the link between food insecurity and heart health, with food support programs potentially helping manage blood pressure. Lastly, the Gastroenterology Clinic arm will investigate how improving access to nutritious foods could benefit digestive health, although more research is needed in this area.12567
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Program Refinement
Refinement of the I-FRESH program based on input from stakeholders before clinic roll-out
Implementation
Roll-Out Implementation Optimization (ROIO) of the I-FRESH program in clinics
Follow-up
Follow-up assessments to determine fit, track utilization, and determine need for additional referrals
What Are the Treatments Tested in This Trial?
Interventions
- Food Referrals
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Families with children who attend the Gastroenterology Clinic for malnutrition or MASLD and indicate that they are experiencing food insecurity on the 2-item screener will be eligible for participation in this group.
Families with children who attend the Preventive Cardiology Clinic for hypertension and/or high cholesterol and indicate that they are experiencing food insecurity on the 2-item screener will be eligible for participation in this group.
Families with children who attend the Obesity Clinic in Endocrinology and indicate that they are experiencing food insecurity on the 2-item screener will be eligible for participation in this group.
Families with children who attend the Type 2 Diabetes Clinic and indicate that they are experiencing food insecurity on the 2-item screener will be eligible for participation in this group.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Rady Children's Hospital, San Diego
Collaborator
Citations
Food Insecurity in Digestive Diseases
Although, studies are still needed to determine if these interventions improve patients' health, they have been shown to improve the resources ( ...
Food insecurity screening practices in a pediatric ...
Among patients evaluated at a pediatric gastroenterology clinic, 10%−15% of caregivers report being asked about food insecurity. · Among providers, more than 53% ...
3.
journals.lww.com
journals.lww.com/ajg/fulltext/2025/10002/s816_food_insecurity__the_impact_of_food_deserts.817.aspxThe Impact of Food Deserts in IBD Malnutrition Screening
Food deserts often lack transportation to obtain healthy food. Guidelines recommend annual screening for micronutrient deficiencies to lessen disease burden. We ...
Feeding hope: A quality improvement initiative to ...
Food insecurity screening can be implemented in a pediatric gastroenterology clinic using quality improvement methods. Interventions that ...
Preventive Services for Food Insecurity: Evidence Report ...
Results One RCT (n = 789) examined the impact of screening for food insecurity and found no difference in food insecurity after 6 months (29.6% ...
Screening for Food Insecurity: US Preventive Services ...
At the end of the study period (24 weeks), the intervention was associated with reduced food insecurity (41.9% with food insecurity while ...
Retrospective review of food insecurity screening in an ...
Food insecurity affects stroke survivors at a rate ranging from 8 % to 42 %, with the higher end being four times the national average of 10.2 % ...
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