Food as Medicine Study (FAME)

Parkland Health and Hospital System

Status: Not yet enrolling

Conditions: Chronic Diseases in Children

Treatments: Behavioral: Food Navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT07162350

STU20251104

Details and patient eligibility

About

The Food as Medicine (FAME) intervention aims to improve dietary quality in lower income, primarily ethnic minority youth through food navigation that bridges clinical care and community food resources. This study will evaluate the FAME intervention on dietary quality, food behaviors, health outcomes, and cost-effectiveness, using a pragmatic randomized clinical trial design in 250 at risk youth (8-15 years of age) and their caregiver(s) as compared to Usual Care through the following aims:

Aim 1: To evaluate the impact of the FAME intervention on child and caregiver(s) dietary quality at 6 and 12 months as compared to Usual Care. Hypothesis: FAME participants will have increased dietary quality as measured by ASA-24/DQI.

Aim 2: To assess the intervention's impact on food behaviors, food insecurity, healthy food sourcing, knowledge, self-efficacy, health outcomes and cost-effectiveness at 6 and 12 months as compared to Usual Care.

Aim 3: Evaluate implementation outcomes including dose, satisfaction, and individual interviews and focus groups with youth, parents, physicians, clinic staff, community partners, and CHWs.

Enrollment: 250 estimated patients

Sex: All

Ages: 8 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• between the ages of 8-15 years,
• BMI > 85th percentile, and
• be seen at one of the selected Parkland COPC (Community Oriented Primary Care) clinics.
• Both the participant and caregiver must be fluent in English or Spanish (read, write, and speak) and be willing to participate in the study over a 12-month duration.

Exclusion criteria

• has seen a dietitian within the last year,
• presence of an intellectual disability,
• diagnosed with autism with severe feeding difficulties,
• past medical history of severe feeding difficulties over the age of 2 years,
• has had bariatric surgery
• is taking a GLP-1
• diagnosed with type 1 diabetes
• is taking anti-psychotics
• has severe food allergies
• has a severe psychiatric disorder
• has a disease that would not allow the individual to change their diet, and
• any other reason the PIs deem someone ineligible.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Usual Care

No Intervention group

Description:

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.

FAME

Experimental group

Description:

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.

Treatment:

Behavioral: Food Navigation