NCT07162350NARecruiting

Food as Medicine Study

Parkland Health and Hospital System

Start Date

6/1/2026

Completion Date

6/30/2028

Summary

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.

Eligibility Criteria

Age Range: 8 years to 15 years

Eligibility Criteria: Inclusion criteria for the participant include: 1. Between the ages of 8-15 years, 2. Have risk factors of chronic disease based on elevated BMI (\>25; 85th percentile), 3. Be seen at one of the selected Parkland COPC clinics, 4. Have not completed a dietitian visit within the last 12 months, 5. 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 for the participant include presence of any of the following: 1. Autism with feeding difficulties 2. Intellectual disability 3. Cushing Disease 4. Severe feeding difficulties for over 2 years 5. Dietary restrictions (medically prescribed) 6. Severe food allergy 7. Severe psychiatric disorders 8. Non-alcoholic fatty liver disease 9. Non-alcoholic steatohepatitis 10. Metabolic-associated fatty liver disease 11. Metabolic-associated steatohepatitis 12. Type 1 Diabetes 13. Antipsychotics 14. GLP1 Medication Prescribed 15. Bariatric Surgery 16. Pregnancy

Interventions

BEHAVIORAL

Food Navigation

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Conditions

Chronic Diseases in Children

Locations

Parkland Health & Hospital System

Dallas, Texas 75390

United States