RECRUITING Not applicable ClinicalTrials.gov

Food as Medicine Study

Sponsor: Parkland Health and Hospital System • ClinicalTrials.gov ID: NCT07162350

Registry updated: 2026-09-03

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Description

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.

Interventions

Food Navigation (Behavioral)
For those randomized to the FAME Intervention, it will begin with a Community Health Worker (CHW) Food Navigator consultation. The role of the Food Navigators is as follows: 1. Identify the top dietary and food needs of the participant and their family. The Food Navigator will perform a needs assessment to define food access, kitchen resources/capacity, and other social determinants of health. 2. Set realistic, participant and family-driven nutrition goals. The Food Navigator will utilize Motivational Interviewing (MI), an evidence-based method of counseling that promotes motivation for change. 3. Provide nutrition resources and referrals. 4. Support children and families for up to 12 months.

Eligibility criteria

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

Conditions

Chronic Diseases in Children

Locations

Parkland Health & Hospital System — Dallas, Texas, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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