Food Navigation for Chronic Childhood Diseases

(FAME Trial)

Overseen By Meera Patel, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Parkland Health and Hospital System

Must not be taking: GLP-1, Antipsychotics

Disqualifiers: Intellectual disability, Autism, Type 1 diabetes, Bariatric surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a "Food as Medicine" approach can help children from lower-income backgrounds improve their eating habits and overall health. It compares a new program, which uses community health workers to connect families with local food resources, to the usual care that includes dietitian consultations and nutrition education. The trial aims to determine if the new program more effectively improves dietary quality, food behaviors, and health outcomes than the usual care. Children aged 8–15 with a high BMI (body mass index) who visit certain Parkland clinics may be suitable participants. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could lead to better health solutions for children.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking a GLP-1 or anti-psychotics, you are not eligible to participate.

What prior data suggests that the FAME intervention is safe for improving dietary quality in youth?

Research shows that using food to improve health is generally safe for both children and adults. Studies have found that these methods can enhance diet quality and health without major risks. In programs where food is part of a health plan, participants have experienced benefits like lower A1C levels, indicating better blood sugar control.

The idea of using food as medicine aims to prevent or help treat health issues through better nutrition. This approach is well-accepted because it focuses on improving diet rather than adding new medications. While insufficient food is linked to health problems in children, programs providing healthier food options have not reported serious side effects. Overall, using food as medicine is considered a safe way to boost health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Food as Medicine (FAME) approach because it introduces a novel way to manage chronic childhood diseases through community-driven food resources. Unlike the usual care, which primarily involves consultations with dietitians and nutrition education, FAME leverages community health workers as food navigators. These navigators help connect families directly to local food hubs, making nutritious food more accessible and personalized to the needs of the child. This method not only addresses dietary needs but also aims to create a sustainable, community-based support system, potentially leading to better health outcomes for children.

What evidence suggests that the FAME intervention could improve dietary quality in at-risk youth?

Research has shown that "Food as Medicine" programs can improve health, particularly for individuals with long-term illnesses. Studies indicate these programs can help reduce body weight and enhance overall well-being by focusing on better eating habits, which can lower the risk of chronic health problems. In this trial, participants will be divided into two groups: the Usual Care group, reflecting current clinical practices, and the FAME intervention group. The FAME intervention employs a community health worker food navigator embedded in clinical settings to provide education and connect participants to a community-based food hub. A review found that several "Food is Medicine" trials in the U.S. positively affected non-communicable diseases. These programs often link medical care with community food resources, helping people access healthier food options. ^{3 6 7 8 9}

Who Is on the Research Team?

Jaclyn Albin, MD

Principal Investigator

Parkland Health

Are You a Good Fit for This Trial?

This trial is for lower income, primarily ethnic minority youth aged 8-15 with chronic childhood diseases and their caregivers. Participants must be at risk of poor dietary quality. Specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

Participants must be seen at one of the selected Parkland COPC clinics

I am between 8 and 15 years old.

My BMI is above the 85th percentile.

Exclusion Criteria

Participant has seen a dietitian within the last year

Participant has presence of an intellectual disability

Participant has severe food allergies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the FAME intervention, which includes food navigation and education to improve dietary quality and health outcomes

12 months

Regular visits for intervention and monitoring

Follow-up

Participants are monitored for changes in dietary quality, health outcomes, and cost-effectiveness after the intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Food as Medicine Study

Trial Overview The study tests a 'Food as Medicine' intervention designed to improve diet through food navigation connecting clinical care with community resources. It compares the effects on diet, health outcomes, and cost-effectiveness against usual care in a randomized setup.

How Is the Trial Designed?

Group I: FAME Experimental Treatment 1 Intervention

The FAME intervention will be evaluated with a pragmatic randomized clinical trial. FAME will use a community health worker food navigator embedded in clinical settings to provide education and linkage to a community-based food hub that provides access to community driven food resources.

Group II: Usual Care Active Control 1 Intervention

The Usual Care control group reflects current clinical practices given to patients. This includes having access to routine wrap around services such as consultation with a dietitian and nutrition education materials. Providers provide references to applicable wrap around services; however, it is ultimately up to the patient to decide to utilize the resources.

Who Is Running the Clinical Trial?

Parkland Health and Hospital System

Lead Sponsor

Trials

20

Recruited

99,300+

University of Texas Southwestern Medical Center

Collaborator

Trials

1,102

Recruited

1,077,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12051899/

Food is Medicine: The Effectiveness of Delaware's Feeding ... The Feeding Families program contributes to improving health outcomes among populations with chronic diseases, particularly in reducing BMI and promoting ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2161831325000572

Advances in Food-As-Medicine Interventions and Their ... FAM thereby aims to 1) promote health, improve overall well-being, and reduce risk of developing chronic diseases [15], 2) reduce healthcare and medication ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001343

A Systematic Review of “Food Is Medicine” Randomized ... This review identified a total of 14 randomized controlled trials of Food Is Medicine interventions in the United States with noncommunicable disease outcomes.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07221045

NCT07221045 | A Food As Medicine Approach to Address ... This project will pilot test and explore the impact of PhytoRx Families (PhtyoRxF) on nutrition-related, health-related, and healthcare utilization outcomes.

5. binasss.sa.cr binasss.sa.cr/feb24/15.pdf

food as medicine across the pediatric age continuum Purpose of review. Poor diet and food insecurity contribute to the dramatic rise in diet-related chronic disease and increasing cost of healthcare.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10763717/

Narrative review: food as medicine across the pediatric age ... Data from adult and population-level interventions provide evidence that FAM interventions positively impact diet quality, food security, health outcomes, and ...

7. feedingamerica.org feedingamerica.org/about-us/press-room/feeding-america-and-elevance-food-as-medicine-initiative

Food as Medicine Report Patients participating in our 'Food as Medicine' programs have experienced measurable improvements, including an average 1.5% reduction in A1C ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2839376

Chronic Conditions and Food Insecurity in US Children Food insecurity is associated with several adverse child health outcomes, including asthma, anemia, and poor mental health. National nutrition ...

9. healthaffairs.org healthaffairs.org/doi/10.1377/hlthaff.2024.00585

'Food Is Medicine' In The US: A National Survey Of Public ... We conducted the first national survey on knowledge, perceptions, and experiences around Food Is Medicine during February–April 2023.